Clinical performance of 3 endodontic sealers Tuomas M. T. Waltimo, DDS, PhD,a Jan Boiesen, DDS,b Harald M. Eriksen, DDS, PhD,c and Dag Ørstavik, DDS, PhD,d Bern, Switzerland, and Oslo and Haslum, Norway NIOM (SCANDINAVIAN INSTITUTE OF DENTAL MATERIALS), UNIVERSITY OF BERN, AND UNIVERSITY OF OSLO
Objective. Calcium hydroxide is used in endodontics as an interappointment dressing. Its inclusion in salicylate resin or zinc oxide-eugenol–based sealers for filling root canals also may lead to a better treatment outcome. The purpose of the present study was to compare the clinical/radiographic treatment outcome of 3 sealers, 2 of which contain calcium hydroxide. Study design. Two hundred and four teeth underwent a standardized endodontic treatment regimen and were assigned to 1 of 3 groups at the time of root filling: group PS, teeth filled with gutta-percha and Procosol sealer; group CR, teeth filled with gutta-percha and CRCS sealer; and group SA, teeth filled with gutta-percha and Sealapex sealer. The results of the treatment were assessed yearly for up to 4 years by clinical and radiologic (periapical index scores) controls. The ridit statistic (r) was used to compare PAI scores among the groups. Results. The overall treatment results were comparable with, but slightly poorer than, results previously obtained from patients seen at the Dental School at the University of Oslo. During the first year after filling, the mean ridit value decreased from .51 ± .039 to .31 ± .042 (∆r = .20) in the SA group. Corresponding values went from .43 ± .030 to .38 ± .035 (∆r = .05) in the PS group and from 37 ± .045 to .34 ± .050 (∆r = .03) in the CR group. At the 2-year examination, teeth in group SA had slightly better periapical conditions (r = .22 ± .045) than did teeth in group PA (r = .30 ± .037) or in group CR (r = .30 ± 052). The difference was statistically significant at P = .01. By years 3 and 4, no significant difference among the groups was detected. Conclusions. The overall influence of the sealer on treatment outcome was small. Root fillings with salicylate resin containing Ca(OH)2 may support more rapid healing of apical periodontitis or operative trauma, but the results after 3 and 4 years were as good for zinc oxide-eugenol–based sealers with or without Ca(OH)2.
(Oral Surg Oral Med Oral Pathol Oral Radiol Endod 2001;92:89-92)
Control and elimination of root canal infection are achieved by the combined action of several host and treatment factors. Chemomechanical preparation and disinfectant medicament dressing eliminate microorganisms in the root canal system. Host defense factors—sometimes supported by the systemic administration of antibiotics—limit the spread of infection. Furthermore, permanent obturation of the root canal prevents recurrent infection. For decades, gutta-percha has been considered the most adaptable and compatible core material for root fillings.1,2 On the other hand, a number of different formulations of sealer cements are used in conjunction with gutta-percha.3 Several investigations have been carried out with respect aVisiting Scientist, NIOM (Scandinavian Institute of Dental Materials), Haslum, Norway; Postdoctoral Fellow, Department of Conservative Dentistry, School of Dental Medicine, University of Bern, Bern, Switzerland. bAssistant Professor, Department of Endodontics, University of Oslo, Oslo, Norway. cProfessor, Department of Endodontics, University of Oslo, Oslo, Norway. dSenior Scientist, NIOM (Scandinavian Institute of Dental Materials), Haslum, Norway. Received for publication Dec 20, 2000; returned for revision Feb 1, 2001; accepted for publication Mar 19, 2001. Copyright © 2001 by Mosby, Inc. 1079-2104/2001/$35.00 + 0 7/15/116154 doi:10.1067/moe.2001.116154
to the mechanical and biological properties of different sealers.4-9 This reflects the clinical interest in these materials and the belief that the type of sealer used will influence the outcome of endodontic treatment.5,10-12 Calcium hydroxide has been widely used in the treatment of various pathologic conditions in teeth.13 Many of its advantages are presumably based on its prolonged release of calcium and hydroxide ions.14 Calcium hydroxide is believed to aid in the production of secondary dentin,15 the induction of apical closure of immature teeth, and the healing of periapical lesions.16-18 It may also prevent root resorption19 and repair perforations resulting from internal root resorption.20 Calcium hydroxide is commonly used as an interappointment root canal dressing because of its effectiveness in disinfecting the root canal system before permanent filling.13,21 In addition, it is also incorporated in some root canal sealers. The inclusion of calcium hydroxide in salicylate resin or zinc oxide-eugenol (ZOE)–based sealers for filling root canals may lead to a better treatment outcome.22 It is difficult to compare the results of different studies that use success/failure analyses in the radiographic assessment of treatment results of apical periodontitis. Therefore, comparisons among sealers should not be based on different studies. The periapical index (PAI) has been found to be a useful and reliable tool for assessing the outcome of endodontic therapy.10,23 The aim of our 89
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ORAL SURGERY ORAL MEDICINE ORAL PATHOLOGY July 2001
Fig 1. Sealer effect on periapical status. Fig 2. Periapical change in 3 sealer groups. Only teeth that could be followed for 2 years or more are included.
Table I. Sealers used in study Sealer
Group
Manufacturer
Principal constituents Salicylate, sulfonamide, calcium hydroxide ZOE, rosin
Sealapex
SA
Kerr (Orange, Calif)
ProcoSol
PS
CRCS
CR
DentalEZ Group (Malvern, Pa) Coltène/Whaledent Inc (Mahwah, NJ)
previously described.23 Briefly, in the PAI system, a score of 1 to 5 is assigned to each root. Score 1 denotes radiographically healthy periapex, whereas scores 2 to 5 represent increasing severity of apical periodontitis.
ZOE, calcium hydroxide
prospective study was to compare 3 different sealers used in endodontic therapy and evaluate the effect of incorporated calcium hydroxide on the outcome of therapy.
MATERIAL AND METHODS In the present study, 204 teeth underwent a standardized endodontic treatment regimen and were assigned to 1 of 3 groups at the time of root filling: group PS, teeth filled with gutta-percha (GP) and Procosol sealer; group CR, teeth filled with GP and CRCS sealer; and group SA, teeth filled with GP and Sealapex sealer (Table I). Treatment was provided by undergraduate students at the University of Oslo who used each of the 3 sealers in a minimum of 2 cases. The results of the treatment were assessed yearly, for up to 4 years, at clinical and radiologic follow-up examinations (by using PAI scores). Examination and diagnosis The initial examination entailed registration of the following: (1) soft tissue status; (2) percussion sensitivity; (3) tooth mobility; (4) coronal and radicular restorations present; (5) presence of approximal contacts, antagonists, and prosthetic involvement; and (6) marginal bone level. The pulpal diagnosis was made on the basis of anamnesis, x-ray analysis, and examination of pulpal contents. The periapical status was assessed by means of the PAI scoring system, as
Endodontic treatment Root canal instrumentation was performed with hand instruments according to a standardized method, as previously described.24 The student learned of the sealer to be used at the time the tooth was ready to be filled. A standardized GP master point was used, and cold lateral condensation and insertion of accessory points completed the root filling of each root. The root filling was characterized with respect to the size of the GP point, the type of sealer, and the quality and extension of the root filling as assessed radiographically. Control examination The patients participated in a yearly recall program of clinical/radiologic examination for 4 years. The clinical examination was carried out as described earlier. The periapical situation was assessed by viewing a radiograph of each tooth, and each tooth was assigned a PAI score. The scores were used for quantitative analysis of the treatment results. The PAI scores were recorded by an investigator who did not know either which sealer was used or the scores obtained with previous radiographs of the same root. Design of the study and data treatment The sealer was considered the dependent variable of the study. The other clinical and radiologic variables of known or possible influence on treatment prognosis were recorded for description or stratification of the material. The ridit statistic (r) was used to compare PAI scores of the 3 groups of sealers.10,25 The PAI scores
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Waltimo et al 91
Table II. Patient attendance Available for examination Year 0 1 2 3 4
No. 204 151 133 115 59
Teeth extracted*
No data available
%
No.
%
No.
100 74 65 56 29
0 1 3 3 0
0 1 2 3 0
%
0 52 68 86 145
0 25 33 42 71
*The percentage of extracted teeth was calculated with respect to the total number of teeth available for examination in that year.
Table III. Patient attendance in different groups Groups Time (y)
SA
PS
CR
0 1 2 3 4
56 48 41 37 16
95 68 60 49 29
42 34 31 28 14
were analyzed for the total number of teeth at start and at the yearly exams. Separate analyses were performed on patients who could be followed for a period of 2 years or more. Each patient was assigned an endpoint PAI score at the last examination.
RESULTS Patient attendance over the 4-year period is reported in Tables II and III. During the first year after filling, the mean ridit value decreased from .51 ± .039 to 31 ± .042 (∆r = .20) in the SA group. Corresponding values went from .43 ± .030 to 38 ± .035 (∆r = .05) in the PS group and from 37 ± .045 to .34 ± .050 (∆r = .03) in the CR group. At the 2-year exam, teeth in group SA had slightly better periapical conditions (r = .22 ± .045) than did teeth in group PA (r = .30 ± .037) or in group CR (r = .30 ± 052). The difference was statistically significant at P = .01. This tendency was apparent in teeth with preoperative apical periodontitis as well as in teeth without preoperative apical periodontitis. By years 3 and 4, this difference was no longer detectable (Fig 1). The periapical change in the 3 groups at the beginning and at the last recall is shown in Fig 2. No significant difference was detected among the groups. When the groups were stratified according to the pretreatment PAI scores, the success rates were congruent in the 3 groups (Fig 3). DISCUSSION The sealers used in the present study were chosen because of their different chemical formulas: (1) Procosol sealer is based on ZOE and contains no
Fig 3. Success rates in 3 sealer groups with different pretreatment PAI scores. Teeth with initial PAI scores of 3, 4, or 5 have been pooled in category 3+. PAI scores 1 or 2 at final follow-up define success.
calcium hydroxide, (2) CRCS is a ZOE-based sealer with incorporated calcium hydroxide, and (3) Sealapex is a salicylate-based sealer that contains calcium hydroxide. All of the 3 sealers are widely used in endodontic practice. The PAI scoring system ensures unbiased assessment of the periapical condition, with reproducible data for comparison of the variables that influence treatment outcome. The sealers were the important independent variable in this study. The PAI system has previously been shown to be a reliable endpoint dependent variable for such comparative studies.10,23,26 The results with respect to the treatment outcome of all the teeth were comparable with previous results obtained from patients seen at the same clinic.10,27 At the 2-year examination, teeth in group SA had significantly better periapical conditions than did teeth in groups PA or CR. By years 3 and 4, this difference was no longer detectable during examination (Fig 1). The results are well in agreement with animal testing reports of Sealapex sealer. Leonardo et al11 compared the histopathologic treatment outcome of dogs’ vital teeth treated with Sealapex, CRCS, Sealer 26, and Apexit sealers and stated that half a year after the treatment, Sealapex was the sealer that best permitted the deposition of mineralized tissue at the apical level. Furthermore, when Sealapex was used, no inflammatory infiltrate was observed and there was no reabsorption of mineralized tissues. On the contrary, inflammatory infiltrate was observed when CRCS sealer was used. In addition, in another report on induced apical periodontitis in dogs, the histopathologic analysis 270 days after root canal treatment showed significantly better periapical repair in teeth obturated with Sealapex than in teeth obturated with a ZOE-based sealer.12
92 Waltimo et al
The results of the present study and the previous reports, with respect to treatment outcome, with Sealapex can be partially explained by the differences between inflammatory responses to these sealers. Sealapex sealer seemed to induce a shorter period of detectable tissue necrosis than did CRCS, Apexit, or Sealer 26 sealers in investigations in mice.9 In the same study, a more pronounced differentiation of cells of the mononuclear phagocyte system into macrophages, epithelioid cells, and multinucleated giant cells was associated with the use of Sealapex sealer. The authors state that this is likely to be due to the release of calcium ions, which induce cell differentiation and macrophage activation.9 Similar findings were also reported by Tronstad et al.28 These findings are further in accordance with an in vitro report of the calcium hydroxide ionization of 4 root canal sealers, in which Sealapex showed significantly higher alkalinity, ionic calcium, and total calcium values than did CRCS, Apexit, and Sealer 26 sealers.8 Silva et al8,9 described macrophage and giant cell differentiation that occurred in conjunction with the use of Sealapex and CRCS sealers, and earlier results from our laboratory showed extensive giant cell responses to calcium hydroxide–forming sealers.6 This may have implications for the clearance of microbial infection in the periapical area.
CONCLUSIONS Root fillings with salicylate resin that contain Ca(OH)2 may ensure more rapid healing of apical periodontitis or operative trauma, but the results after 3 and 4 years were statistically indistinguishable from those obtained by using ZOE-based sealers with or without Ca(OH)2.
ORAL SURGERY ORAL MEDICINE ORAL PATHOLOGY July 2001
9. 10. 11.
12.
13.
14.
15. 16. 17. 18. 19. 20. 21.
22. 23.
REFERENCES 1. Anthony LP, Grossman LI. A brief history of rootcanal therapy in the United States. J Am Dent Assoc 1945;32:43-50. 2. Sundqvist G, Figdor D. Endodontic treatment of apical periodontitis. In: Ørstavik D, Pitt Ford TR, editors. Essential endodontology. Oxford, UK: Blackwell Science; 1998. p. 242-77. 3. Ørstavik D. Endodontic materials. Adv Dent Res 1988;2:12-24. 4. Ørstavik D. Physical properties of root canal sealers: measurement of flow, working time, and compressive strength. Int Endod J 1983;16:99-107. 5. Spångberg LSW. In vitro assessment of the toxicity of endodontic materials. Int Endod J 1981;14:27-34. 6. Ørstavik D, Mjör IA. Histopathology and X-ray microanalysis of the subcutaneous tissue response to endodontic sealers. J Endod 1988;14:13-23. 7. Abdulkader A, Duguid R, Saunders EM. The antimicrobial activity of endodontic sealers to anaerobic bacteria. Int Endod J 1996;29:280-3. 8. Silva LA, Leonardo MR, Faccioli LH, Figueiredo F.
24. 25. 26. 27. 28.
Inflammatory response to calcium hydroxide based root canal sealers. J Endod 1997;23:86-90. da Silva LA, Leonardo MR, da Silva RS, Assed S, Guimaraes LF. Calcium hydroxide root canal sealers: evaluation of pH, calcium ion concentration and conductivity. Int Endod J 1997;30:205-9. Ørstavik D, Kerekes K, Eriksen HM. Clinical performance of three endodontic sealers. Endod Dent Traumatol 1987;3:178-86. Leonardo MR, da Silva LA, Utrilla LS, Assed S, Ether SS. Calcium hydroxide root canal sealers–histopathologic evaluation of apical and periapical repair after endodontic treatment. J Endod 1997;23:428-32. Tanomaru Filho M, Leonardo MR, da Silva LA, Utrilla LS. Effect of different root canal sealers on periapical repair of teeth with chronic periradicular periodontitis. Int Endod J 1998;31:85-9. Byström A, Claesson R, Sundqvist G. The antibacterial effect of camphorated paramonochlorophenol, camphorated phenol and calcium hydroxide in treatment of infected root canals. Endod Dent Traumatol 1985;1:170-5. Rehman K, Saunders WP, Foye RH, Sharkey SW. Calcium ion diffusion from calcium hydroxide-containing materials in endodontically-treated teeth: an in vitro study. Int Endod J 1996;29:271-9. Zander HA. Reaction of the pulp to calcium hydroxide. J Dent Res 1939;18:465-87. Crabb HS. The basis of root canal therapy. Dent Pract 1965;15:397-401. Kennedy GD, McLundie AC, Day RM. Calcium hydroxide, its role in a simplified endodontic technique. Dent Mag Oral Top 1967;84:51-7. Kennedy GD, Simpson MS. The hollow tube controversy. J Brit Endod Soc 1969;3:51-7. Andreasen JO. Treatment of fractured and avulsed teeth. ASDC J Dent Child 1971;38:29-31. Frank AI, Weine FS. Non-surgical therapy for the perforation defect of internal root resorption. J Am Dent Assoc 1972:87:863-8. Cvek M, Hollender L, Nord CE. Treatment of non-vital permanent incisors with calcium hydroxide. VI. A clinical, microbiological and radiological evaluation of treatment in one sitting of teeth with mature or immature root. Odontol Revy 1976:27:93-108. Holland R, DeSouza V. Ability of a new calcium hydroxide root canal filling material to induce hard tissue formation. J Endod 1985;11:535-43. Ørstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol 1986;2:20-34. Kerekes K, Tronstad L. Long-term results of endodontic treatment performed with a standardized technique. J Endod 1979:5:83-90. Bross IDJ. How to use ridit analysis. Biometrics 1958:14:18-38. Ørstavik D. Reliability of the periapical index scoring system. Scand J Dent Res 1988;96:108-11. Ørstavik D, Hørsted-Bindslev P. A comparison of endodontic treatment results at two dental schools. Int Endod J 1993;26:348-54. Tronstad L, Barnett F, Flax M. Solubility and biocompatibility of calcium hydroxide-containing root canal sealers. Endod Dent Traumatol 1988;4:152-9.
Reprint requests: Dag Ørstavik, DDS, PhD NIOM, PO Box 70 N-1344 Haslum, Norway
[email protected]