Effect of One-Suture and Sutureless Techniques on Postoperative Healing After Third Molar Surgery

Accepted Manuscript The effect of one-suture and suture-less techniques on post-operative healing following third molar surgery. Dr. Saleh Alkadi, BDS(Hons), MFDS RCSI, D.Ch.Dent, FFD RCSI, Prof. Leo Stassen, FRCS(I), FDSRCS, MA, FTCD, FFSEM, FFDRCSI, FICD PII:

S0278-2391(18)31298-9

DOI:

https://doi.org/10.1016/j.joms.2018.12.001

Reference:

YJOMS 58543

To appear in:

Journal of Oral and Maxillofacial Surgery

Received Date: 21 March 2018 Revised Date:

26 October 2018

Accepted Date: 1 December 2018

Please cite this article as: Alkadi S, Stassen L, The effect of one-suture and suture-less techniques on post-operative healing following third molar surgery., Journal of Oral and Maxillofacial Surgery (2019), doi: https://doi.org/10.1016/j.joms.2018.12.001. This is a PDF file of an unedited manuscript that has been accepted for publication. As a service to our customers we are providing this early version of the manuscript. The manuscript will undergo copyediting, typesetting, and review of the resulting proof before it is published in its final form. Please note that during the production process errors may be discovered which could affect the content, and all legal disclaimers that apply to the journal pertain.

ACCEPTED MANUSCRIPT Title: The effect of one-suture and suture-less techniques on post-operative healing following third molar surgery.

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Author: Dr. Saleh Alkadi BDS(Hons), MFDS RCSI, D.Ch.Dent, FFD RCSI Specialist Oral Surgeon, Dept of Oral and Maxillofacial Surgery, St. Finbarr's Hospital, Cork, Ireland. Email: [email protected] Tel: +353860875470 Co-author: Prof. Leo Stassen FRCS(I), FDSRCS, MA, FTCD, FFSEM, FFDRCSI, FICD

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Professor/Chair of Oral and Maxillofacial Surgery, Dept of Oral and Maxillofacial Surgery, St James's Hospital, Dublin 8, Ireland; Department of Oral and Maxillofacial Surgery, Dublin Dental University Hospital, Lincoln Place, Dublin 2, Ireland.

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Abstract Objective: Wound closure technique for lower third molar surgery (LTMS) is an operative factor that influences wound healing and early post-operative complications. This study investigates two closure techniques; partial closure using one suture and the suture-less

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technique, after using a modified buccal envelope flap for LTMS.

Materials and methods: This is a prospective, randomized, double-blind, split mouth controlled trial. Partial closure using one suture was compared to the suture-less technique. Surgical sites were divided into two groups, Group A: one suture, and Group B: suture-less.

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Each patient received both treatments at the same time. During the first post-operative week, all patients were asked to daily assess pain, facial swelling, and bleeding, using self-

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assessment scales. All patients attended follow-up appointment at one week, to objectively assess facial swelling and wound healing, and at one month, to assess wound healing. Analysis of data was carried out using the statistical package SPSS (IBM SPSS Statistics 24). A p value ≤ 0.05 was accepted as statistically significant.

Results: Thirty- seven patients, who had bilateral impacted third molars of similar surgical difficulty,

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were recruited. Thirty-four successfully completed the study. The results showed a statistically

significant difference between the two techniques in a) post-operative pain at day five (p = 0.046), and six (p = 0.034), b) socket healing at one week (p = 0.002), and one month (p =

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0.014), and c) soft tissue healing at one week (p = 0.016).

Conclusion: One-suture technique for LTMS is superior to the suture-less technique in

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reduction of post-operative pain, and improving wound healing during early post-operative period. There is no difference between the two techniques in reduction of post-operative swelling.

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Introduction

Lower third molar surgery is one of the most common surgical procedure in oral and

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maxillofacial surgery.[1] As for any other surgical procedures, it has its own risks and postoperative complications, that influence the recovery period, and affect the patient’s quality of life.[2, 3] Pain, limitation of mouth opening, and clinical evidence of facial swelling have a

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significant effect on the oral health related quality of life during the immediate post-operative period.[4] Wound healing after lower third molar surgery has a significant clinical

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importance for the clinician, as delayed healing and wound dehiscence make hygiene more difficult and may require more intense follow-up treatment, which potentially extends the time of post-surgical care.[5]

The type of healing of the surgical wound is one of the factors most closely linked to post-

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operative complication, following lower third molar surgery. [6] There are two mechanisms for healing in the surgical site that can take place, primary or secondary. The type of wound healing is determined by the closure technique utilized, and the number of sutures used by the

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surgeon. In secondary healing, a communication between the socket and the oral cavity is

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maintained by using no suture, or by closing the flap partially, using a small number of sutures.[7-19] This secondary healing could also be achieved by removing a wedge of mucosa over the extraction socket. [6, 20-25] In primary healing, the socket is closed completely (primary closure/complete closure), with the overlying mucosal flap hermetically sealed, to achieve primary healing of the socket. A surgeon uses two to three sutures to achieve this primary closure, and, sometimes, a modification to the flap design is necessary to facilitate advancing the flap over the extraction socket. [13, 15, 20, 21] Placement of a

ACCEPTED MANUSCRIPT dressing, or insertion of a drain into the lower third molar surgical wound have been used to modify wound healing, and alleviate post-operative complications. [26-29] Surgeons in favor of primary closure claim that it decreases the risk of post-operative infection, while those who are supporting secondary closure suggest that it allows for better

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drainage of inflammatory exudates, which results in reduced pain, and less swelling. [30] This conflicting opinions have evolved into a wide variety of partial closure techniques, that have been tested, and compared to the traditional complete closure technique in several

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recent clinical trials. [30]

Materials and Methods

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The purpose of this study was to investigate the effect of a partial wound closure technique, using different number of sutures, on post-operative complications, following lower third molar surgery. We hypothesized that there is no difference between using one suture after lower third molar surgery and suture-less lower third molar surgery, in terms of degree of wound healing and post-operative complications. The specific aims of the study were to compare the two techniques in terms of the following outcomes: 1) post-operative pain during the first week, 2) post-operative facial swelling during the first week, 3) wound healing at one week and at one month post-surgery, 4) periodontal condition of the adjacent lower second molar at one month, 5) post-operative bleeding during the first week, and 6) post-operative infection and dry socket during the first week.

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Ethical approval for this clinical trial was granted from SJH/AMNCH Research Ethics Joint

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Committee in Ireland.

Sample and study design

In order to investigate the effect of wound closure technique, through using different number of sutures, on the post-operative complications, following lower third molar surgery, we carried out this prospective, randomised, double-blind, split-mouth controlled study. The study population was composed of all patients who require the removal of both lower third molars only, at the Department of Oral and Maxillofacial Surgery in the Dublin Dental University Hospital between May 2016 and April 2017. who require the removal of both lower third molars only. To be included in the study sample, patients had to fulfil the following requirements: 1) Patient is suitable for treatment under local anesthetic with intravenous conscious dental sedation

ACCEPTED MANUSCRIPT 2) Full thickness mucoperiosteal flap required, with bone removal, with or without tooth sectioning for removal of both lower third molars, which have similar eruptive state and similar difficulty

4) No known congenital or acquired bleeding tendency 5) Aged between 18 and 45

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3) ASA Grade I or II

6) Participants, who are willing to cooperate with the requirements of the study protocol.

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Patients were excluded as study subjects if :

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1) patient does not want to take part in the study, or is unable to give informed consent for the procedure involved 2) patient does not require the removal of both lower third molars in line with NICE guidelines 3) patient is not suitable for treatment under local anaesthetic with intravenous conscious sedation. 4) patient has a medical condition that could be complicated by the procedure (ASA >II). 5) Surgery does not require a full thickness mucoperiosteal flap or bone removal. 6) patient is under 18 years of age or over 45 years of age. 7) patient is pregnant or a nursing mother. 8) patient who has an allergy or cannot tolerate the antibiotic and the analgesics used in the study.

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Surgical sites were randomized into one of two Groups using random-numbers table generated using a random sequence generator: Group A: Sites received one suture, and Group

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B: suture-less sites.

Power calculation

The sample size in previous similar published studies have ranged from 19 to 50 patients, with an average of 37 patients, who required 74 surgical removals of lower third molars [912]. In order to detect a difference in the mean change in pain severity and facial swelling between the two treatment groups, a Power Calculation has shown that at least thirty-one

ACCEPTED MANUSCRIPT participants with sixty-two surgical sites, were needed to achieve an Alpha of 0.05 and Power of at least 0.9.

Variables and outcomes measurement

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Demographic variables

The following demographic variables were collected : age, gender, body mass index (BMI), smoking status, ASA grade, OCP use, and ethnicity distribution within the study population.

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Primary subjective outcomes

All participants were questioned as close as possible to post-operative hour 12, 24 and then

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daily up to the seventh day from completion of the surgery using a standardized questionnaire, to assess post-operative bleeding, post-operative discomfort, post-operative swelling, and the patient adherence to the use of post-operative medications and mouth rinse. The degree of pain and discomfort was rated by the participant for each side using an eleven-

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point Numeric Rating Scale (NRS) where 0 indicates “no pain” and 10 indicates worst imaginable pain (Fig.1). [31] The degree of facial swelling for each side was also evaluated by the participants using six-point Visual Analogue Scale (VAS), where 0 indicates “no

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swelling”, and 5 indicates “extreme severe swelling” (Fig. 2).[32] The degree of bleeding

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was evaluated for each side by counting the number of gauzes needed to stop bleeding on the day of surgery and the following post-operative days. Also, participants recorded the day on which they felt bleeding had stopped completely.

Primary objective outcomes Facial swelling was evaluated using the method described by Montebugnoli et al in 2004, and by Szolnoky et al in 2007 [33, 34]. In this method the patient is placed in neutral head

ACCEPTED MANUSCRIPT position, six baseline linear measurements are recorded in (mm) on each side of the face by using a special measuring tape to measure the linear distances between six reproducible anatomical landmarks (Fig. 3).[35] One examiner recorded all measurements for all participants pre-operatively, and at one week post-operatively. The difference between the

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two reading was used to give an objective evaluation of the amount of residual facial swelling, at one week post-operatively.

Three clinicians, who are specialist oral-maxillofacial surgeons, evaluated the post-operative

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wound healing independently. All clinicians were informed of the study protocol, and were calibrated, and trained on using the indices according to the description of the evaluation

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criteria using clinical photos. All clinicians were independent observers and were not involved in any aspects of the surgical procedure, or site allocation to either group. Agreement on evaluation was achieved between the assessors when they were asked to assess the same patient. The surgeon, who performed the surgery, removed the suture before the

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other assessors carried out the wound healing assessment.

The degree of socket epithelization was graded by the examiner at one week and one month post-operatively using standardized tick sheet (Fig. 4).

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The extent of soft tissue healing at the surgical site was evaluated at one week post-

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operatively using the Healing Index for Soft Tissue by Landry in 1985. [36] This index grades healing into five grades, depending on the color of tissues, epithelialization of wound margins, presence of bleeding on palpation, granulation, and suppuration (Fig. 5). One examiner carried out periodontal examination for lower second molar using a William’s probe. Pocket depth (PD) and Clinical Attachment Level (CAL) were recorded at three buccal sites; mesio-buccal, mid-buccal and disto-buccal. All measurements were recorded pre-operatively, and at one month post-operatively.

ACCEPTED MANUSCRIPT Secondary outcomes Operative time The duration of surgery for each side was recorded in minutes, which corresponded to the period between starting the incision and placement the suture in Group A, and between

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starting the incision and replacing the flap to its original position in Group B. Surgical difficulty

The difficulty level of the surgery as perceived by the surgeon, was rated by the surgeon

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at the completion of each surgery using a four-point category rating scale: low, medium,

difficult, and very difficult. Also, the level of surgical trauma was recorded based on three

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grade difficulty scale: easy, medium, and difficult.

Surgical protocol

Each participant underwent surgical removal of bilateral lower third molars only, under local

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anesthetic and IV conscious sedation, at the same operative visit. All procedures were performed by the same surgeon (3rd Specialist Registrar in Oral Surgery), and under similar operative conditions. Each participant received the following pre-operative oral medications:

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mouth wash.

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amoxicillin 500 mg, paracetamol 1 g, ibuprofen 400 mg and 10 mL of 0.2% chlorhexidine

In theatre, and immediately before the removal of both lower third molars, the surgical sites were allocated to the two intervention groups using the aforementioned randomization method. This allocation was carried out by a nurse and was informed to the surgeon immediately before starting the surgery. Additionally, a coin was tossed to randomly determine which side the surgeon would start the surgical procedure on. Heads indicated the right side, and tails indicated the left side. After IV access was established using a 22G or a 20 G cannula, a conscious sedation agent, midazolam, was administered incrementally and

ACCEPTED MANUSCRIPT titrated against the patient’s response. Surgical drapes were placed with the patient’s eyes totally covered. Anesthesia was achieved using lidocaine hydrochloride 2% with epinephrine 1:80,000. Two 2.2 mL cartridges were administered – one for the inferior alveolar and lingual nerves, and one for buccal nerve. A buccal envelope flap using Stassen’s modification (Fig.

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6) was raised through crevicular incision from the distal of the third molar to the papilla between the first and second molar, including the papillae between the first, second and third molars. A small distal reliving incision was made from the position that the distobuccal cusp

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of the third molar would occupy if the tooth were in a vertical position to a maximum of 5 mm in length. Lingual nerve protection, when needed, was provided by raising a lingual flap

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using a Mitchell’s trimer and protected using a Howarth’s retractor as advised by Rogers and Stassen [37]. Bone removal was carried out using a tungsten carbide fissure bur (HP Oral Surgery TF 702, DENTSPLY, Switzerland), in a straight handpiece, under sterile 0.9 normal saline continuous irrigation. When necessary, sectioning of the crown and roots was

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performed. Once the tooth removal has been completed, removal of granulation tissue and gentle curettage of the socket were carried out, and followed by gentle irrigation using a twenty-mL sterile saline wash. The flap was then repositioned. Surgical sites in Group A

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received one suture just distal to the lower second molar placed through the buccal and

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lingual papilla (Ethicon, 3-0 coated vicryl rapide W9935, Johnson & Johnson, Belgium) (Fig. 7). Surgical sites in Group B did not receive any suture. Direct pressure was applied to the surgical site using sterile gauze moistened with 0.9 normal saline. Once the first site had been completed, the surgeon performed the surgical removal on the opposite side using the same technique. For each surgical site, the operator recorded operative details, operative time, perceived level of difficulty, and degree of surgical trauma using a three-grade difficulty scale described by O’Neill and Stassen in 2014 (Fig. 8).[38] Post-operatively, participants were instructed to use the following oral medications: amoxicillin 500 mg, three

ACCEPTED MANUSCRIPT times daily for five days, paracetamol 1 g and ibuprofen 400 mg, six hourly for three days, and then as needed. They were also instructed to use chlorhexidine mouth wash 0.2%, 10mL, once daily, and salty mouth rinse, three times daily, for one week. Patients were reviewed at

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one week, and one month following the procedure.

Statistical methods

Analysis of data was carried out using the statistical package SPSS (IBM SPSS Statistics 24).

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A p value ≤ 0.05 was accepted as statistically significant. A Wilcoxon Signed Ranks Test was used to assess for differences in pain and swelling, as rated by the patient, between the two

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groups. It was also used to assess for the difference between the two groups in socket healing and soft tissue healing. A McNemar’s Test was used to assess differences in food impaction. Dependent t-tests were conducted to assess for difference in swelling measured at one week, bleeding, and a change in periodontal condition for lower second molar. We used

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Spearman Rho Correlation test rather than multivariate analysis, to assess the effect of surgical difficulty and operative time on the measured outcomes, as the use of multivariate

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Results

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analysis requires a larger sample size.

Sample size and characteristics

Out of 37 participants enrolled in this trial, 35 participants underwent bilateral lower third molar surgeries. Two were excluded, and one was lost at one month follow-up. Of those, who were excluded, one was excluded as surgical procedure of one side took longer time than usual, and the surgery on the other side was postponed, another participant was excluded, as one of the inclusion criteria was lost on the day of surgery.

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The sample consisted of 25 females, and ten males, with an age range of 18 to 37, and a mean age of 26.6 (SD = 4.85). BMI of participants ranged from 18.7 to 39.9 (M = 25.25, SD = 4.87). All patients but one were Caucasian (97%) and one (3%) was Afro-American.

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Twenty-nine patients (83%) were ASA grade I, while six patients (17%) were graded ASA II. Seven patients (20%) were regular smokers. Of the female participants, ten (40%) were on the contraceptive pills. The use of the split-mouth design created no statistically significant

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difference between the two investigated groups in age, gender, BMI, OCP use, smoking, and

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ASA grade.

The mean operative time for the sutured side was 21.5 minutes with a range of 7 to 36 minutes; while the mean operative time for the suture-less side was 19.5 minutes with a range of 7 to 50 minutes. There was no statistical significant difference in operative time between

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the sutured side (M = 21.49, SD = 7.83) and the suture-less side (M = 19.51, SD = 9.15), t (34) = 1.022, p = 0.314. There was also no statistical significant difference in surgical

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difficulty between the two investigated groups (z = -0.660, p = 0.505).

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Dry socket and infection

Seven cases of dry socket were reported in this clinical trial (10%), three patients developed bilateral dry sockets, and one patient suffered dry socket at the suture-less side. No cases of infection arouse during the evaluation period.

ACCEPTED MANUSCRIPT Post-operative pain There was a statistically significant difference in post-operative pain between the two groups on the fifth day, z = -1.99, p = 0.046, and on the sixth day, z = -2.12, p = 0.034. Pain severity was greater on the non-sutured side (Table. 1; Fig. 9). The results of Spearman Correlation

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(Table. 2) indicate that, as the difference in the degree of surgical difficulty increased, so did the difference in severity of pain from day one to day six. In addition, as the difference in

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operative time increased, so did the pain severity at five of the seven measurement periods.

Facial swelling

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For post-operative facial swelling as perceived by the patient, there were no differences between the sutured and non-sutured sides at all evaluation days (all p > 0.05) (Table. 3; Fig. 10). The results of Spearman Correlation (Table. 4) indicate that the greater the difference between sutured and non-sutured sides in operative time and degree of surgical difficulty, the

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greater the difference in post-operative swelling perceived by the patient on day one through six (all p <0 .05). For post-operative facial swelling measured at one week, there was no significant differences between the suture and non-suture conditions at all measured lines (all

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p >0 .05) (Table. 5; Fig. 11).

Post-operative bleeding

There were no significant differences in the number of gauzes required to address the bleeding (all p >0 .05). There was also no significant difference in the duration of bleeding, t(34) = -1.14, p = 0.263( Table. 6).

Wound healing

ACCEPTED MANUSCRIPT For socket healing, there was greater degree of healing for the sockets under the suture condition when compared to the non-suture condition at one week, z = -3.10, p = 0.002, and one month z = -2.45, p = 0.014 (Fig.12; Fig.13). Also, surgical sites evidenced a greater level of soft tissue healing at one week under the suture condition, z = -2.41, p = 0.016 (Fig.14).

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The results of Spearman Rho Correlation showed no relationship between operative time or surgical difficulty, with degree of socket and soft tissue healing (all p >0 .05). Although nonsuture sites showed more food impaction than sutured sites at one week and one month, there

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was no significant difference between the two conditions at one week, p = 0.508 and at one month, p = 1.00. There were no differences between the two conditions in the three measures

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of periodontal status for lower second molar at one month, all p >0 .05 (Table. 7).

Discussion

Closure technique is an operative factor that has been linked to early post-operative

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complications after lower third molar surgery. [21, 26] When compared to primary closure, secondary closure techniques have shown better reduction in post-operative pain [6, 8-12, 1417, 19-27, 39], post-operative swelling [6, 8-14, 17, 19-27, 39], and trismus [8, 14-17, 22-24,

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27, 39, 40] following lower third molar surgery. has shown good

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Suture-less technique, a relatively new secondary closure technique,

outcomes following lower third molar surgery. [7] Regardless of the flap design used for lower third molar surgery, suture-less technique has proven to be superior to primary closure technique in reducing post-operative pain, swelling, and trismus. [8-12, 39] In addition to its desirable effect on post-operative complications, suture-less technique decreases surgical time, minimizes the trauma resulting from soft tissue manipulation, and decreases direct costs. [7] In this clinical trial, we investigated the effect of closure technique on post-operative

ACCEPTED MANUSCRIPT complications, and wound healing following lower third molar surgery. We compared two secondary closure techniques; partial wound closure using one suture and the suture-less technique, after using a modified buccal envelope flap for accessing lower third

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molar surgery.

Post-operative pain

In this clinical trial, we used an 11-point Numeric Rating Scale (NRS), to assess pain

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severity, at seven different time points- hour twelve, day one, two, three, four, five and six. The validity of this pain scale has been demonstrated and proven to correlate significantly

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with other pain scales such as the Visual Analogue Scale (VAS).[41-44] In addition to its easy administration to the patient, it is more useful than other scales for audit ,and research. [45]

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Across seven evaluation time points in this clinical trial, the pain intensity was reported to be a maximum at twelve hours post-operatively, this is in agreement with findings from several studies in the literature which suggest that pain following lower third molar surgery reaches

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its maximum intensity in the first twelve hours. [46]

The difference in pain scores between the two techniques from day one to day four was not significant (p > 0.05) in this clinical trial. This is in agreement with the findings by De Brabander and Cattaneo in 1988, who compared two secondary closure techniques; wedge mucosa excision to wedge mucosa excision with tube drain, and found no statistical significant difference in pain intensity at day two and day seven between the two techniques. [47] This could be explained by the fact that acute inflammatory response peaks within

ACCEPTED MANUSCRIPT seventy-two hours after the surgery and then diminishes gradually, and in both techniques, there is an outlet for these inflammatory mediators to be washed out.

The results of this clinical trial demonstrated a significant difference in the median pain

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scores, between the two closure techniques, at day five and day six post-operatively (p ≤ 0.05). Greater pain scores were reported in the suture-less sides at day five (p = 0.046) and day six (p = 0.034). This could be related to the delayed wound healing being observed in the

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suture-less sites at one week following the surgery. Delayed healing could result in a longer period of discomfort and continuous pain which is caused by hypersensitivity in the exposed

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distal root surface of the adjacent second molar. [5]

In previous studies, the suture-less technique has been found to have a decreased pain

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intensity during the early few days following lower third molar surgery when compared to primary closure. [8-12, 39] These findings have been also reported when the one-suture technique is compared to the primary closure technique, one suture technique has

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demonstrated significant reduction in pain intensity during the first seventy-two hours after

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the surgery. [14] However, there are no previously published studies comparing the sutureless technique to the one-suture, or other secondary closure techniques.

Post-operative swelling There are different methods described in the literature to measure facial swelling following third molar surgery, some of them are easy to use, while the others are sophisticated or too complex for clinical use.[6] These methods use either subjective or objective evaluation.

ACCEPTED MANUSCRIPT Objective methods used in previous studies include photographic techniques [48], Magnetic Resonance Imaging (MRI) [49], stereo-photographic techniques [50, 51], ultrasound [52], facebow apparatus [26], cephalostat [32], 3-D optical scanning technique [53], and craniometrics measurements using different methods. [35, 47, 54] In 1982, Dubois et al used

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a two-grade scale as a self-assessment method by the patient to measure the swelling following lower third molar surgery. A few years later, Henrikson et al in 1985 proposed the use of VAS as a subjective method to measure facial swelling, when they compared the effect

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of two anti-inflammatory drugs, on the post-operative complications, following lower third molar surgery.[55] This self-assessment method has been proven to be reliable and accurate

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in assessing facial swelling, when compared to observer assessment [56], or 3-dimesional mechanical measurement using an extra-oral cephalostat. [32] In later clinical trials, subjective evaluation of swelling by the patient has been utilized using different scales, for

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measuring facial swelling, following lower third molar surgery. [6, 19, 20, 22, 24, 25, 28, 57]

In this clinical trial, we used two methods to evaluate facial swelling; 1) objective method to measure swelling at one week time using craniometrics measurements described by

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Montebugnoli et al in 2004 [33] and used also by Szolnoky et al in 2007 [34], and 2) a

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subjective self-assessment method using VAS described by Berge [32] , to assess swelling from post-operative day one to day six by the patient.

In the present study, the reported facial swelling reaches its maximum at forty-eight hours post-operatively, these results match those observed in earlier studies, which suggest that facial swelling following lower third molar surgery reaches its maximum intensity at fortyeight hours following the surgery. [14, 16, 19, 29, 58-60]

ACCEPTED MANUSCRIPT The result of this clinical trial revealed no significant difference between the two techniques in facial swelling as measured by the patient from day one to day six (p > 0.05). Also, there was no significant difference between the two techniques in the objective facial swelling measurements at one week (p > 0.05). These results are consistent with those of De

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Brabander and Cattaneo in 1988, who compared two secondary closure techniques, and found no statistical significant differences in facial swelling at day two, and day seven between the two techniques. [47] A possible explanation for this might be that both

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techniques investigated in the present study have an outlet for the accumulated fluids and the inflammatory exudates to escape, which results in reduced post-operative facial swelling.

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[30]

Wound healing

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Several studies have reported significantly less post-operative facial swelling in suture-less technique when compared to primary wound closure following lower third molar surgery. [812, 39] This significant reduction in facial swelling has been also reported in the one-suture technique when compared to the primary closure technique, where the former has shown significant reduction in facial swelling during the first seventy-two hours after lower third molar surgery. [14] Although these findings have been also reported when other partial closure techniques are compared to primary closure [13, 17, 19], other studies showed no benefits of secondary closure over primary closure technique in reducing facial swelling following lower third molar surgery. [15, 16, 18, 40]

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Different methods have been used in the literature to assess wound healing following lower third molar surgery, these methods include: recording dehiscence at the incision lines [6, 21, 24], time to achieve satisfactory healing [24, 26], mucosal attachment level and periodontal health around the adjacent lower second molar [11, 15, 21], presence of infection or dry socket [6, 11, 20, 21, 39, 57, 61], the need for additional treatment [26], food debris lodgment, and cleansablility of the extraction socket. [9, 21, 23, 39]

ACCEPTED MANUSCRIPT Unlike the previously mentioned studies, which did not use specific scale to assess wound healing, Rakprasitkul and Pairuchvej in 1997, described a four-grade index to assess wound healing following lower third molar surgery, this index depends

on degree of wound

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breakdown, and exposure of the extraction socket. [28]

The wound healing in the present clinical trial was assessed by measuring different clinical parameters. The parameters comprise degree of socket healing, soft tissue healing, presence

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of infection or dry socket, presence of food impaction within the socket, and periodontal

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health at the buccal site of the adjacent lower second molar.

The assessment of socket healing was carried out using a five-grade index to measure the degree of socket epithelization, which was designed specifically for the purpose to be used by

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investigators in this study.

The results of this trial demonstrated a statistically significant better socket healing on sites received one suture, at one week (p = 0.002) and one month (p = 0.014) following lower third

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molar surgery. Incision line dehiscence and flap displacement were reported at one week

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post-operatively in five suture-less flap (14.3%) and one sutured flap (2.9%).

The degree of soft tissue healing at the surgical site was evaluated using Landry’s index [36], in which each surgical site is given a score from one to five , the higher the score the better the healing of soft tissue at that surgical site. The results of this study showed a statistically significant better soft tissue healing at one week post-operatively, on sites received one suture, compared to suture-less sites (p = 0.016).

ACCEPTED MANUSCRIPT There are no previous published studies in the literature comparing wound healing between secondary closure techniques. Some investigators reported better wound healing associated with primary closure, when compared to various secondary closure techniques [21, 24, 26], Rakprasitkul and Pairuchvej in 1997 reported no difference in wound healing, when

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compared primary closure alone to primary closure with tube drain placement.[28]

Seven cases of dry socket were reported in this clinical trial (10%), three patients developed

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bilateral dry sockets, and one patient suffered dry socket at the suture-less side. No cases of infection arouse during the evaluation period. When compared to primary closure technique,

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Hashemi et al in 2012 reported no dry socket in the suture-less group, or the primary closure group [11], Ricard et al in 2015 reported two cases of dry socket and two cases of infection in the primary closure group, and no cases reported in the suture-less group. [39] Interestingly, a study by Akota et al in 1998 reported a significant increase in dry socket

gauze drain. [57]

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incidence when the wound closed primarily, when compared to the wounds that received

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A few studies have reported a higher incidence of food impaction in the suture-less technique

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[9, 39], and other secondary closure techniques [23], when compared to primary closure. The results of this trial showed no significant difference between the two techniques with food impaction within the socket at one week (p = 0.508) and one month (p = 1.00) postoperatively.

Looking at the periodontal condition buccal to the adjacent lower second molar at one month following the surgery, there were no statistically significant differences in the change from pre-operative values of the pocket depth (p = 0.484), and clinical attachment level (CAL) (p

ACCEPTED MANUSCRIPT = 0.875) between the two groups. Comparing suture-less technique to primary closure at six month following lower third molar surgery, Hashemi et al in 2012 reported no significant change in pocket depth around the lower second molar from pre-operative value on either technique. [11] Interestingly, three months following lower third molar surgery, Xavier et al

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in 2008 reported greater pocket depths at three sites on the buccal surface of lower second molar in primary closure compared to secondary closure, and this difference was statistically

SC

significant at one site. [15]

Post-operative bleeding

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A subjective method was used to compare post-operative bleeding between the two techniques in this clinical trial. The patient was asked to count the number of gauzes used to stop bleeding, for each surgical site, on each day post-operatively, also, the patient reported the time needed to achieve a bleeding-free surgical site. The results of this trial showed no

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significant difference between the two techniques in post-operative bleeding. There were no reported cases of excessive bleeding that needed any intervention through a local dentist or the emergency department at the dental hospital. These results are in line with those observed

EP

by Hashemi et al in 2012, who reported no cases of excessive bleeding, when they compared

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the suture-less technique to the primary closure. [11] The same observation was reported by Pasqualini et al in 2005, who compared secondary closure to the primary closure technique, they reported no cases of hemorrhage in either technique.[6] Contrary to Pasqualini et al , Bello et al in 2011 reported a significant higher incidence of reactionary bleeding at fortyeight hours in the secondary closure technique cases when compared to primary closure. [13]

ACCEPTED MANUSCRIPT Using a four-grade scale to measure post-operative bleeding , Rakprasitkul and Pairuchve in 1997 reported less bleeding in patients who received a tube drain when compared to patients receiving primary closure only. [28]

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Effect of surgical difficulty and operative time

In this clinical trial, we were able to demonstrate a strong correlation between the level of surgical difficulty measured on the difficulty index and the operative time measured in

SC

minutes. This finding seems to be consistent with other research, which stated that the duration of lower third molar surgery reflects its level of difficulty [62, 63], and hence

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operative time has been used in several studies as a tool to measure the difficulty of surgery. [3, 64-67]

The results of this trial showed that, as the difference in the degree of surgical difficulty

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increased between lower third molar surgeries, so did the difference in severity of postoperative pain from day one to day six. In addition, as the difference in operative time increased, so did the pain severity at five of the seven measurement periods.

EP

This agrees with most of the studies, which reported increased pain severity and discomfort

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when lower third molar surgery takes longer time [13, 47, 68-71], and when the lower third molar surgery reaches a higher level of difficulty. [70, 72-74]

The results demonstrate that differences in operative time and degree of surgical difficulty are related to differences in post-operative swelling; the greater the difference between lower third molar surgeries in operative time and degree of difficulty, the greater the difference in post-operative swelling. These results are in keeping with previous studies, which showed

ACCEPTED MANUSCRIPT more post-operative swelling in difficult lower third molar surgery [75], or when surgery takes longer time. [76, 77]

Limitations and future direction

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One of this study limitations is the short follow-up period which was not long enough to fully assess the periodontal condition around the lower second molar. We were unable

to measure the PD and CAL at the distal site of the second molar as the wound healing

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has not been completed at one month time following the surgery. Ideally, an additional three to six-month follow-up appointment is required to investigate the periodontal

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condition at the distal surface of the lower second molar. We were also unable to investigate the effect of the two closure techniques on the post-operative trismus, as both treatments were carried out at the same time. A clinical trial of parallel-group design is required in order to

Conclusion

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investigate the effect.

The results of this trial demonstrated that post-operative pain and wound healing are

EP

influenced by the type of the closure technique used by the surgeon. The results also showed

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that operative time and difficulty of surgery have an impact on the severity of post-operative complication.

The results of this clinical trial suggest that the placement of one suture, distal to the lower second molar, after raising a buccal envelope flap (Stassen modification) for lower third molar surgery, is superior to the suture-less technique, in decreasing post-operative pain and enhancing wound healing. Further research is required to compare the one-suture technique to suture-less technique and to the primary closure technique. A multi-centric, double blind trial with large cohort size, and split-mouth design would be the ideal.

ACCEPTED MANUSCRIPT

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ACCEPTED MANUSCRIPT 76.

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Figures legend

Fig. 1. Eleven-point Numeric Rating Scale (NRS) for pain (McCaffery and Pasero, 1999).

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Fig. 2. VAS scale for swelling with references given to patient (Berge, 1988). Fig. 3. Facial measurements for evaluation of facial swelling (Szolnoky et al., 2007). Fig. 4. Grades of socket healing.

Fig. 5. Healing Index for Soft Tissue by Landry (Landry, 1985).

Fig. 6. Modified buccal envelope flap for lower third molar surgery.

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a) Envelope incision, b) 5 mm disto-buccal extension from site of the distobuccal cusp with no extension into the cheek. It protects a high lying lingual nerve, if it lies over

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the retromolar triangle as it occasionally does, c) it allows subperiosteal dissection of the retromolar tissues from retromolar triangle with a Mitchell’s trimmer, d) it gives a

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very clean and clear access to the impacted lower third molar, the bone and provides easy access to the subperiosteal lingual tissue, if retraction is required.

Fig. 7. Suture site in one-suture technique. Fig. 8. Surgical Difficulty Scale (O’Neill and Stassen 2014). Fig. 9. Median pain ratings for suture and non-suture conditions. Fig. 10. Median facial swelling for suture and non-suture conditions. (0 = no swelling, 1 = slight swelling, 2= mild swelling, 3 = severe swelling, 4= very severe swelling).

ACCEPTED MANUSCRIPT Fig. 11. Means for differences between pre-operative and post-operative values for facial swelling measurements from lines 1 to 6. Fig. 12. Histogram of socket healing for suture and non-suture conditions at one week. Fig. 13. Histogram of socket healing for suture and non-suture conditions at one month.

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Fig. 14. Histogram of soft tissue healing for suture and non-suture conditions at one week.

ACCEPTED MANUSCRIPT Tables

Table 1. Means and standard deviations and results of the Wilcoxon Signed Rank Tests for pain perceived by patient on days one to six under suture and non-suture conditions.

48 Hours

72 Hours

Day 4

Day 5

Suture

4.85

2.45

Non-Suture

5.25

2.41

Suture

4.57

2.06

Non-Suture

4.34

2.09

Suture

4.65

2.09

Non-Suture

4.51

1.96

Suture

4.28

Non-Suture

4.45

Suture

3.80

Non-Suture

4.51

Suture

3.25

2.64

4.34

2.65

2.65

2.32

3.74

2.58

Non-Suture Day 6

Suture

AC C

EP

Non-Suture

* p ≤ 0.05

Deviation

z

p

-.628

.530

-1.10

.270

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24 Hours

Std.

-.811

.417

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12 Hours

Mean

SC

Condition

2.44

-.230

.818

-1.29

.196

-1.99

.046*

2.12

.034*

2.48

2.50 2.60

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Time

ACCEPTED MANUSCRIPT

Table 2. Spearman Rho Correlations between differences in operative time and difficulty of surgery with differences in pain perceived by the patient from day one to day six

12 Hours 24 Hours 48 Hours 72 Hours

Day 6

r

.372

.367

.522**

.321

.342

.386

.306

p

.028*

.030*

.001*

.060

.045*

.022*

.074

n

35

35

35

35

35

35

35

r

.365

.386

.516**

.541**

.535**

.519**

.514**

p

.031*

.022*

.001*

.001*

.001*

.001*

.002*

n

35

35

35

35

35

35

35

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EP

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* p ≤ 0.05 ** r = 0.4 to 0.59 indicates moderate correlation

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Difficulty Scale

Day 5

SC

Operative Time

Day 4

ACCEPTED MANUSCRIPT

Day 2

Day 3

Day 4

Day 5

Mean

Std. Deviation

Suture

2.62

1.330

Non-Suture

2.40

1.264

Suture

2.74

1.357

Non-Suture

2.48

1.291

Suture

2.28

1.250

Non-Suture

2.11

1.182

Suture

1.74

1.244

Non-Suture

1.60

Suture

1.05

Non-Suture

1.11

Suture

.828

Non-Suture

.742

EP AC C

p

-1.31

.190

-1.33

.183

-.835

.404

-.806

.420

1.034

.937

-.068

.946

-.847

.397

.963

.857 .852

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Day 6

z

SC

Day 1

Condition

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Time

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Table 3. Means and standard deviations and results of Wilcoxon Signed Rank Tests for swelling perceived by patient days one to six under suture and non-suture conditions.

ACCEPTED MANUSCRIPT

Table 4. Spearman Rho Correlations between differences in operative time and difficulty of surgery with differences in swelling perceived by patient from day one to day six. Day 3

Day 4

Day 5

Day 6

.501

**

.536

**

.538

**

.395

.478

*

.002

*

.001

*

.001

*

.019

*

.004

r

.537

p

.001

n

35

35

35

**

.426

*

.011

r

.514

p

.002

n

35

35

**

.469

*

.005

35

35

TE D EP AC C

35

**

.543

*

.001

*

35

**

.453

*

.006

35

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* p ≤ 0.05 ** r = 0.4 to 0.59 indicates moderate correlation

**

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Difficulty Scale

Day 2

**

SC

Operative Time

Day 1

35

**

.433

*

.009 35

** *

ACCEPTED MANUSCRIPT

Table 5. Means, standard deviations, and dependent t-tests for difference in facial swelling measurements.

Line 4

Line 5

Line 6

Total*

t

p

Suture

.1200

.272

1.062

.296

Non-Suture

.0657

.250

Suture

.1343

.341

Non-Suture

-.0171

.315

Suture

.0829

.434

Non-Suture

-.0086

.393

Suture

.1371

.548

Non-Suture

.0029

.586

Suture

.2200

Non-Suture

.1371

Suture

.0743

Non-Suture

-.1400

Suture Non-Suture

1.917

.064

.865

.393

1.172

.249

.576

.568

1.462

.153

1.893

.067

.586

.604 .796

2.102

.0400

2.001

EP AC C

.829

.7686

* Total = summation of lines 1 to 6.

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Line 3

Std. Deviation

SC

Line 2

Mean

M AN U

Line 1

Condition

TE D

Line

ACCEPTED MANUSCRIPT

Table 6. Means and standard deviations and results of the t-tests for number of gauzes used through days one to five and duration of bleeding under suture and non-suture conditions.

Mean

Std. Deviation

1.42

1.70

Non-Suture

1.74

2.22

Suture

.657

1.37

Non-Suture

.571

1.17

Suture

.057

.338

Non-Suture

.028

.169

Suture

.000

Non-Suture

.000

Suture

.000

Non-Suture

.000

Bleeding

Suture

1.31

duration

Non-Suture

Day 3

Day 4

Day 5

.000

1.40

-1.23

.227

.683

.499

.442

.661

a

.000

.000

a

.000

.529

TE D

Day 2

p

M AN U

Suture

Day 1

t

RI PT

Condition

SC

Time

-1.14

.263

.553

AC C

EP

a = no t-test could be computed due to no variation in gauze usage under both conditions.

ACCEPTED MANUSCRIPT Table 7. Means, standard deviations and results of the t-tests for measures of periodontal status of lower second molar at one month under suture and non-suture conditions.

Mean

Std. Deviation

Average PD

Suture

1.42

1.70

change

Non-Suture

1.74

2.22

CAL

Suture

.657

1.37

change

Non-Suture

.571

1.17

Suture

.057

.338

Non-Suture

.028

.169

Deepest PD

p

-.708

.484

-.159

-.903

AC C

EP

TE D

M AN U

change

t

RI PT

Condition

.875

.373

SC

Parameter

AC C

EP

TE D

M AN U

SC

RI PT

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AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT

AC C

EP

TE D

M AN U

SC

RI PT

ACCEPTED MANUSCRIPT