Intraoral adhesive bandage

Section

of the

Federal dental services

Intraoral adhesivebandage Charles A. Babbush, Lieutenant DENTAL

DETACHMENT,

MARINE

(DC) USNR* CORPS

RECRUIT

DEPOT,

PARRIS

ISLAND,

S. C.

I

t is well established that the protection of wounds from mechanical disturbance permits rapid, uncomplicated healing. I-6 At the present time there is no special device available for use a~ a surgical dressing on mucous surfaces, but, an intraoral adhesive bandage has been proposed as an effective means of protecting minor surgical wounds of the oral mucosa, and laboratory studies have been made to determine its safety. In three studies, the intraoral bandage, prepared as a 4 per cent suspension in distilled water, was administered to thirty mice (twenty females and t-en males). With the exception of a temporary weight loss in two mice, the administered dose (1,600 mg. per kilogram of body weight) evoked no signs of toxicity during a lo-day observation period. 7-QThe 4 per cent aqueous suspension was also administered (1,600 mg. per kilogram) intraperitoneally to ten female mice, and no signs of toxicity were noted during the IO-day observation period.” Strips (1 by 2.5 cm.) of the intraoral bandage were also applied to the intact oral mucous membranes of two mature mongrel dogs. A strip was applied in the left buccal fold of each dog, while the right buccal fold was left as a negative control. Examination of the mucous membrane 2, 4, 6, and 24 hours after application of the bandage revealed no evidence of irritation to the oral mucous membrane.lO The prototype bandage is contraindicated as a classic periodontal pack, for tongue or cheek applications, and where acute infection is involved. The opinions or assertions contained herein are the private ones of the author and are not to be construed as official or reflecting the views of the Navy Department or the naval service at large. *Visiting Oral Surgeon, Department of Dentistry and Oral Surgery, Mount Sinai Hospital, University Circle, Cleveland, Ohio 44106.

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PURPOSE

This study was undertaken to make a clinical assessment of the usefulness of the intraoral adhesive dressing* for its intended purpose. The primary purpose of the study was to evaluate the efficacy of the bandage in protecting postoperative wounds from additional trauma, in controlling hemorrhage, and as a means of reducing the need for postoperative analgesic agents. A secondary purpose was to study tissue tolerance, patient acceptance, and duration of adhesion. MATERIALS AND METHODS

The intraoral adhesive dressing is presently available in the form of an odorless, light tan, compressed wafer measuring approximately 3 by 4 by 3/3z inches. There are eight wafers in a package, which is sufficient material for 50 to 100 applications. The wafer has a polyethylene film backing on one side and a layer of removable release paper on the other side. The adhesive wafer is composed of gelatin, pectin, sodium carboxymethyl cellulose, and polyisobutylene. Randages of varying sizes and shapes may be cut from the wafer to fit the needs of the particular application. A portion of sufficient size to cover the wound area may be cut from the standard 3 by 4 by 3/3zinch bandage. It was found that the most convenient and sterile way to use the bandage was to keep a wafer and a straight bandage scissors in a sterile covered pan. After scrubbing for an operation and prior to instituting surgical manipulation, a piece of bandage large enough to cover the anticipated wound was cut from the wafer and placed on a sterile tray. Thus, the wafer was not contaminated, and the remainder could be used for other cases. At the conclusion of the surgical procedure, the bandage was cut and molded to cover the wound adequately. The release paper (an opaque sheet) was removed to expose the adhesive, and the bandage was applied to the mucous surface, with the adhesive side facing the wet tissue. The bandage was held firmly in place for l/z to 1 minute to initiate adhesion, which was then sustained as a result of the extremely hydrophilic properties of the component materials. Since bleeding enhances adhesion, it was not necessary to sut,ure the wounded area. None of the patients were instructed to abstain from food or fluids while the bandage was in place. Preliminary

study

A preliminary study was made of 400 patients selected at random from the recruits, permanently assigned personnel, and dependents undergoing oral surgical procedures at the Dental Department, Marine Corps Recruit Depot, Parris Island, South Carolina. During the course of this study, the oral adhesive dressing was applied to 474 surgical wounds. *Orahesive bandage (intraoral bandage) for application to the oral mucosa and gingiva. Lot No. BA 311-68/l&AB-3, E. R. Squibb & Sons, New York, Division of Olin Mathieson Chemical Corporation. Made in the U. 8. A.; supplied by E. R. Squibb & Sons Co,, Inc.

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study

Following the preliminary study, a blind controlled study was instituted. To ensure random sampling, this study included the next 100 patients who required extractions in more than one quadrant. Each patient served as his own control. Random chance determined which site in each patient would be the experimental site. Experimental sites and control sites were as similar as possible. Thus, if the experimental site was in the premolar region, the control site usually was in the same region. The oral adhesive dressing was applied to the experimental site or wound ; the control site or wound received no dressing other than a gauze pressure pack. Postoperative

evaluation

A standard evaluation form was devised for this study to ensure impart.ial analysis of the postoperative condition of the patients. Only after completion of the controlled study were the notations compared with the patients’ reeords to determine which had been the experimental site and to establish which site was superior. Each patient returned to the clinic on the first postoperative day and was questioned as to duration of adhesion, hemorrhage, and analgesics required. All these factors were noted on the form. The examiner inspected both sites and noted the relative rates of healing, which were graded as follows: A. Speed of healing 1. More rapid healing-wound had the appearance of 5 to 6 days’ postoperative healing 2. Same speed of healing-self-explanatory 3. Delayed healing-wound had a discolored appearance, or a considerable clot was present B. Degree of healing 1. Marked improvement-wound was clean, had good coloration of the tissues, and was clinically asymptomatic 2. Moderate improvement-advanced healing, but not of the outstanding quality of the first category 3. Slight improvement-very difficult to differentiate from no change 4. No change-self-explanatory 5. Slight retardation-poorly colored tissues with possibility of a breakdown or postoperative infection 6. Marked retardation-any case with infection or in need of a secondary procedure On the same form, the factors of swelling, tenderness, bleeding, and color were assigned numerical values for degrees or categories, as follows: A. Swelling O-None, or extremely slight l-Slight to moderate 2-Moderate to moderately severe 3-Severe

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13. Tenderness O-Patient required no postoperative pain medication l-Patient required one or two doses of postoperative pain medication 2-Patient required postoperative pain medication for 24 hours 3-Patient required postoperative pain medication for 48 hours or longer C. Bleeding O-No further postoperative bleeding after patient left the office l-Oozing and bleeding over the first several hours postoperatively 2-Hemorrhage from the surgical site during the first 24 hours postoperatively 3-Hemorrhage from the surgical site after the first 24 hours, or bleeding during the second postoperative day D. Color 0-Mucosa appeared normal or nearly normal l--Slight color tinges at the gingival crest 2-Socket appeared reddened and somewhat irritated 3-Moderately severe or severe typical inflammatory reaction of the surgical area, socket, and adjacent tissues The grades and numerical values were collated and analyzed statistically by means of the t-test. RESULTS Preliminary

study

The average age of the 400 patients was 19.2 years. During the preliminary study, a total of 655 teeth were removed and 474 intraoral adhesive dressings were applied. The number of teeth extracted ranged from twenty-four in one patient (sixteen in a full maxillary arch extraction) to only one in some patients. The average duration of adhesion was 14.67 hours, the extremes being 1 hour and 52 hours. In one case (Case 152) the polyethylene film backing remained on the extraction site of a lower first molar for 8 days. Only 28.7 per cent of the patients had postoperative bleeding, and only 53.4 per cent required postoperative analgesic agents for pain or discomfort. Clinical observations made on the first postoperative day are shown in Tables I, II, and III.

Table I. Clinical evaluation of speed of healing in 474 wounds bandaged with intraoral adhesive dressings, first postoperative day

“E:&,f More rapid Same Delayed

Number of wounds 329 139 6

Per cent 69.4 29.3 1.3

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E’OUP representative 1 through 9.

cases (Cases 97, 216, 294, and 48) are shown in Figs.

Controlled

study

experimental

The average age of the 100 patients was 19.2 years. During the controlled study, a total of 227 teeth were removed and 100 intraoral adhesive dressings were applied to the experimental wound sites. Comparison of the evaluations of speed of healing of the experimental and control sites (Table IV) revealed that the bandaged site demonstrated more advanced healing in 89 per cent of t.he cases, retarded healing in 10 per cent, and equal healing in 1 per cent (one case). Table V shows the result of a comparison of degrees of healing. The average duration of adhesion of the bandage was 15.6 hours, the extremes being 1 hour and 41 hours. Only 15 per cent of the patients had postoperative bleeding from the bandaged site, whereas 67 per cent had postoperative bleeding from the control site. Statistical analysis proved these findings to be significant (P <

II. Clinical evaluation of degree of healing in 474 wounds bandaged with intraorals adhesive dressings, first postoperative day

Table

Number of wounds

I

Degree

Per cent

165 201 86 16 3 3

Marked improvement Moderate improvement Slight improvement No change Slight retardation Mayked retardation

34.8 43.5 7 8.2 3.4 n.nfi “.-0.05

Ill. Clinical evaluation of 474 wounds bandaged with dressings, first postoperative day

Table

intraoral

No. of woui~Xs with madfestatdons Category

Swelling

1 Ten&rness

1

of: )

Bleeding

adhesive

-COZOT

Y

452 20

243 221

338 122

449 23

32

:

100

131

:

Table IV. Clinical evaluation of speed of healing in 100 wounds bandaged with intraoral adhesive dressings as compared with 100 untreated wounds, first postoperative day Speed of healing

Nwrnber

More rapid Same Delayed

89 1 10

of

wozMza8

Per

oent

89 1;

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Babbush

0.01). Only 18 per cent required postoperative analgesic agents for pain or discomfort of the bandaged site, whereas 63 per cent required medication for pain or discomfort of the control site (P = 0.01). On the first postoperative day, only 1 per cent of the bandaged sites demonstrated swelling, as compared with 20 per cent of the control sites. Discoloration was noted in 10 per cent of the control sites, whereas there was no evidence of discoloration in any bandaged site (Table VI). DISCUSSION The study revealed numerous facts concerning the bandage. The fact that at no time was it necessary to perform a secondary procedure to stop postoperative bleeding attests to the effectiveness of the bandage as a hemostatic agent. Only one case (Case 136) was listed in category 3 (hemorrhage or bleeding after the first postoperative day) ; this patient was previously known to be a postoperative bleeder. Results of the controlled study were dramatic and offered most convincing evidence that the bandage is effective. There is no question that 6he incidence of postsurgical hemorrhage was greatly reduced. In some cases, when the patients ate soon after the surgical procedure and subsequent bandaging, the intraoral adhesive dressing was dislodged ; therefore, it might be advisable to recommend that the patient wait a few hours before eating. In several cases, a “Saran Wrap” film was observed covering the surgical

Table V. Clinical evaluation of degree of healing in 100 wounds bandaged with intraoral adhesive dressings as compared with 100 untreated wounds, first postoperative day Number of t00u9ta5

Degree

Per cent

24 60

Marked improvement Moderate improvement Slight improvement No change Slight retardation Marked retardation

24 60 5

; :, 0

ii

Tcible VI. Clinical evaluation of 100 wounds bandaged with intraoral dressings and 100 untreated wounds, first postoperative day Swelling Category !i 32

Experimental site 99 it+ o+

Tenderness

Control site +

adhesive

Ezperimental site

Control site

80 20

18 82

t+

60 37

0

0

:

ii

%jijqz21

E

1 15 85 o+

+

64 33 21

100 00”

+

909

+

;

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Fig.

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Pia.

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6

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Fig. 5

Fig. 1. Case 97, immediate postoperative view. Full maxillary arch extraction. One quadrant with silk sutures, the other with intraoral adhesive dressing. Fig. B. Case 97, 24-hour postoperative view. Note cleanliness of quadrant which was covered by bandage. Fig. 3. Case 216. All maxillary teeth extracted and alveoleetomy completed. adhesive dressing in position. Fig. 4. Case 216, immediate postoperative view. Intraoral Note relief for labial frenum. Fig. 5. Case 216, 46-hour postoperative view. Note cleanliness of wound and solid configuration of clots. Pig. 6. Case 294. Multiple apicoectomies of right and left maxillary central incisors. Mucoperiosteal flap reflected. Fig. 7. Case 294. Periapieal regions exposed. Fig. 8. Case 294, 4-day postoperative view of apicoectomy wound that was covered with intraoral adhesive dressing. Note migration of gingiva. Fig. 9. Case 48, 24-hour postoperative view of maxillary lateral incisor extraction wounds that were bandaged with intraoral adhesive dressing. Note good ridge form and cleanliness of wounds.

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wound. This represented the remains of the polyethylene backing after the bandage had ‘ ‘washed away. ” In four cases (Case 22, 36, 60, and 67) the alveolus was void of a clot on the first postoperative day. Lack of the clot may have been due to a sudden jarring of the bandage which displaced both clot and bandage. In most cases, the intraoral adhesive dressing was placed with results as good as could be obtained by anesthetizing the patient and placing a suture. In Case 74 the buccal mucosa of the maxillary tuberosity was torn and mutilated as a result of the extraction of a maxillary second molar. The bandage was applied after the tissue had been approximated, and there was no need for sutures. On the other hand, Case 59 involved removal of the maxillary central and lateral incisors, and the degree of approximation of the palatal and buccal mucosa was not as ideal as with sutures. In such cases it might be more beneficial to close the wounds with a single stay suture for better approximation. In Case 294 (Figs. 6, 7, and 8) multiple apicoectomies were performed. After termination of the surgical procedure, the buccal mucoperiosteal flap was repositioned and the intraoral adhesive dressing was then placed without any sutures. After several days it was noted that the flap was migrating in an apical direction. This might have been prevented had a stay suture been placetl in the midline. SUMMARY This study was based on clinical observation of the use of intraoral adhesive dressing in 500 patients. As a result of the favorable findings in a preliminary study of 400 cases, a .lOO-case controlled experimental study was carried out. The results of both the preliminary and experimental studies indicate that the intraoral adhesive dressing can be utilized as an effective oral bandage. The preceding statement is supported by the following observations concerning the effects of the bandage : (1) It promoted advanced healing and protected the postoperative wound, (2) it reduced postoperative hemorrhage, (3) it reduced the need for postoperative analgesics, and (4) in relation to the duration of adhesion, it was well tolerated by the tissues and acceptance by patients was good. Secondary properties of the intraoral dressing are as follows: (1) It is acceptable in its shelf-like properties, (2) it is easy to apply, (3) it is nontoxic, and (4) it is nonantigenic. REFERENCES

1. Shafer, W. G., Hine, M. K., and Levy, B. M.: A Textbook of Oral Pathology, ed. 2, Philadelphia, 19’63, W. B. Saunders Cornperry, pp. 487-506. 2. Robinson, H. B. G.: The Healing of Wounds, Especially Those of the Oral Cavity, J. P. Med. 17: 152-156, 1962. 3. Lyons, D. C.: The Physiology of Oral Surgical Convalescence, .J. D. Med. 17: 121-127, 1962. 4. Mittelman, H. R., Toto, P. D., Sicher, H., and Wentz, F. M.: Healing in the Human Attached Gingiva, Periodontics 2: 106-114, 1964. 5. Hut, M.: Panel Discussion: Complications in Post-extraction Healing, Internat. D. .J. 13: 440-442, 1963. 6. Heifetz, C. J., Lawrence, M. S., and Richards, F. 0.: Comparison of Wound Healing With and Without Dressings, Arch. Surg. 65: 746-751, 1952.

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Bab bush

7. Report from the Toxicology Research, Sept. 27, 1963. 8. Report from the Toxicology Research. Mav 25. 1964. 9. Report from the Toxicology Research, Dec. 23, 1964. 10. Report from the Toxicology Research, Dec. 15, 1964.

and Pathology

Section,

The Squibb

Institute

for

Medical

and Pathology

Section,

The Squibb

Institute

for

Medical

and Pathology

Section,

The Squibb

Institute

for

Medical

and Pathology

Section,

The Squibb

Institute

for

Medical