One-step partial or complete caries removal and bonding with antibacterial or traditional self-etch adhesives: study protocol for a randomized controlled trial

Cyril Villat, Jean-Pierre Attal, Nathalie Brulat, Franck Decup, Sophie Doméjean, Elisabeth Dursun, Hélène Fron-Chabouis, Bruno Jacquot, Michèle Muller Bolla, Nelly Plasse-Pradelle, Laurent Roche, Delphine Maucort-Boulch, Patrice Nony, Kerstin Gritsch, Pierre Millet, François Gueyffier, Brigitte Grosgogeat, Cyril Villat, Jean-Pierre Attal, Nathalie Brulat, Franck Decup, Sophie Doméjean, Elisabeth Dursun, Hélène Fron-Chabouis, Bruno Jacquot, Michèle Muller Bolla, Nelly Plasse-Pradelle, Laurent Roche, Delphine Maucort-Boulch, Patrice Nony, Kerstin Gritsch, Pierre Millet, François Gueyffier, Brigitte Grosgogeat

Abstract

Background: Current concepts in conservative dentistry advocate minimally invasive dentistry and pulp vitality preservation. Moreover, complete removal of carious dentin in deep carious lesions often leads to pulp exposure and root canal treatment, despite the absence of irreversible pulp inflammation. For years, partial caries removal has been performed on primary teeth, but little evidence supports its effectiveness for permanent teeth. Furthermore, the recent development of new antibacterial adhesive systems could be interesting in the treatment of such lesions. The objectives of this study are to compare the effectiveness of partial versus complete carious dentin removal in deep lesions (primary objective) and the use of an antibacterial versus a traditional two-step self-etch adhesive system (main secondary objective).

Methods/design: The DEep CAries Treatment (DECAT) study protocol is a multicenter, randomized, controlled superiority trial comparing partial versus complete caries removal followed by adhesive restoration. The minimum sample size required is 464 patients. Two successive randomizations will be performed (allocation ratio 1:1): the first for the type of excavation (partial versus complete) and the second (if no root canal treatment is required) for the type of adhesive (antibacterial versus traditional). For the two objectives, the outcome is the success of the treatment after 1 year, measured according to a composite outcome of five FDI criteria: material fracture and retention, marginal adaptation, radiographic examination (including apical pathologies), postoperative sensitivity and tooth vitality, and carious lesion recurrence.

Discussion: The study will investigate the interest of a conservative approach for the management of deep carious lesions in terms of dentin excavation and bioactive adhesive systems. The results may help practitioners achieve the most efficient restorative procedure to maintain pulp vitality and increase the restoration longevity.

Trial registration: ClinicalTrials.gov Identifier NCT02286388 . Registered in November 2014.

Keywords: Cavity preparation; Composite resins; Deep carious lesion; Dental adhesives; Partial caries removal; Permanent dentition; Pulp capping; Randomized controlled trial.

Figures

Fig. 1
Fig. 1
Combinations of interventions
Fig. 2
Fig. 2
Flow chart

References

    1. Alexander G, Hopcraft MS, Tyas MJ, Wong RH. Dentists’ restorative decision-making and implications for an ‘amalgamless’ profession. Part 1: a review. Aust Dent J. 2014;59:408–19. doi: 10.1111/adj.12209.
    1. Weber CM, Alves LS, Maltz M. Treatment decisions for deep carious lesions in the Public Health Service in Southern Brazil. J Public Health Dent. 2011;71(4):265–70. doi: 10.1111/j.1752-7325.2011.00258.x.
    1. Schwendicke F, Meyer-Lueckel H, Dörfer C, Paris S. Attitudes and behaviour regarding deep dentin caries removal: a survey among German dentists. Caries Res. 2013;47(6):566–73. doi: 10.1159/000351662.
    1. Schwendicke F, Stolpe M, Meyer-Lueckel H, Paris S, Dörfer CE. Cost-effectiveness of one- and two-step incomplete and complete excavations. J Dent Res. 2013;92(10):880–7. doi: 10.1177/0022034513500792.
    1. Bjørndal L, Reit C, Bruun G, Markvart M, Kjaeldgaard M, Näsman P, et al. Treatment of deep caries lesions in adults: randomized clinical trials comparing stepwise vs. direct complete excavation, and direct pulp capping vs. partial pulpotomy. Eur J Oral Sci. 2010;118(3):290–7. doi: 10.1111/j.1600-0722.2010.00731.x.
    1. Leksell E, Ridell K, Cvek M, Mejàre I. Pulp exposure after stepwise versus direct complete excavation of deep carious lesions in young posterior permanent teeth. Endod Dent Traumatol. 1996;12(4):192–6. doi: 10.1111/j.1600-9657.1996.tb00513.x.
    1. Magnusson BO, Sundell SO. Stepwise excavation of deep carious lesions in primary molars. J Int Assoc Dent Child. 1977;8(2):36–40.
    1. Orhan AI, Oz FT, Orhan K. Pulp exposure occurrence and outcomes after 1- or 2-visit indirect pulp therapy vs complete caries removal in primary and permanent molars. Pediatr Dent. 2010;32:347–55.
    1. Schwendicke F, Dörfer CE, Paris S. Incomplete caries removal: a systematic review and meta-analysis. J Dent Res. 2013;92(4):306–14. doi: 10.1177/0022034513477425.
    1. Thompson V, Craig RG, Curro FA, Green WS, Ship JA. Treatment of deep carious lesions by complete excavation or partial removal: a critical review. J Am Dent Assoc. 2008;139:705–12. doi: 10.14219/jada.archive.2008.0252.
    1. Maltz M, Garcia R, Jardim JJ, de Paula LM, Yamaguti PM, Moura MS, et al. Randomized trial of partial vs stepwise caries removal: 3-year follow-up. J Dent Res. 2012;91(11):1026–31. doi: 10.1177/0022034512460403.
    1. Maltz M, Jardim JJ, Mestrinho HD, Yamaguti PM, Podestá K, Moura MS, et al. Partial removal of carious dentine: a multicenter randomized controlled trial and 18-month follow-up results. Caries Res. 2013;47(2):103–9. doi: 10.1159/000344013.
    1. Ribeiro CC, Baratieri LN, Perdigão J, Baratieri NM, Ritter AV. A clinical, radiographic, and scanning electron microscopic evaluation of adhesive restorations on carious dentin in primary teeth. Quintessence Int. 1999;30:591–9.
    1. Foley J, Evans D, Blackwell A. Partial caries removal and cariostatic materials in carious primary molar teeth: a randomised controlled clinical trial. Br Dent J. 2004;197(11):697–701. doi: 10.1038/sj.bdj.4811865.
    1. Lula EC, Monteiro-Neto V, Alves CM, Ribeiro CC. Microbiological analysis after complete or partial removal of carious dentin in primary teeth: a randomized clinical trial. Caries Res. 2009;43:354–8. doi: 10.1159/000231572.
    1. Phonghanyudh A, Phantumvanit P, Songpaisan Y, Petersen PE. Clinical evaluation of three caries removal approaches in primary teeth: a randomised controlled trial. Community Dent Health. 2012;29(2):173–8.
    1. Franzon R, Guimarães LF, Magalhães CE, Haas AN, Araujo FB. Outcomes of one-step incomplete and complete excavation in primary teeth: a 24-month randomized controlled trial. Caries Res. 2014;48:376–83. doi: 10.1159/000357628.
    1. Bergenholtz G, Axelsson S, Davidson T, Frisk F, Hakeberg M, Kvist T, et al. Treatment of pulps in teeth affected by deep caries - a systematic review of the literature. Singapore Dent J. 2013;34:1–12. doi: 10.1016/j.sdj.2013.11.001.
    1. Ricketts D, Lamont T, Innes NP, Kidd E, Clarkson JE. Operative caries management in adults and children. Cochrane Database Syst Rev. 2013;3:CD003808.
    1. Schwendicke F, Schweigel H, Petrou MA, Santamaria R, Hopfenmüller W, Finke C, et al. Selective or stepwise removal of deep caries in deciduous molars: study protocol for a randomized controlled trial. Trials. 2015;16(1):11. doi: 10.1186/s13063-014-0525-9.
    1. Frencken JE, Peters MC, Manton DJ, Leal SC, Gordan VV, Eden E. Minimal intervention dentistry for managing dental caries - a review: report of a FDI task group. Int Dent J. 2012;62:223–43. doi: 10.1111/idj.12007.
    1. Sidhu SK. Glass-ionomer cement restorative materials: a sticky subject? Aust Dent J. 2011;56(Suppl 1):23–30. doi: 10.1111/j.1834-7819.2010.01293.x.
    1. Wang Z, Shen Y, Haapasalo M. Dental materials with antibiofilm properties. Dent Mater. 2014;30:e1–16. doi: 10.1016/j.dental.2013.12.001.
    1. do Amaral GS, de Cássia Negrini T, Maltz M, Arthur RA. Restorative materials containing antimicrobial agents: Is there evidence for their antimicrobial and anti-caries effects? - A systematic-review. Aust Dent J. 2015. doi:10.1111/adj.12338.
    1. André CB, Gomes BP, Duque TM, Stipp RN, Chan DC, Ambrosano GM, et al. Dentine bond strength and antimicrobial activity evaluation of adhesive systems. J Dent. 2015;43:466–75. doi: 10.1016/j.jdent.2015.01.004.
    1. Imazato S, Kinomoto Y, Tarumi H, Torii M, Russell RR, McCabe JF. Incorporation of antibacterial monomer MDPB into dentin primer. J Dent Res. 1997;76(3):768–72. doi: 10.1177/00220345970760030901.
    1. Imazato S, Kinomoto Y, Tarumi H, Ebisu S, Tay FR. Antibacterial activity and bonding characteristics of an adhesive resin containing antibacterial monomer MDPB. Dent Mater. 2003;19(4):313–9. doi: 10.1016/S0109-5641(02)00060-X.
    1. Imazato S. Antibacterial properties of resin composites and dentin bonding systems. Dent Mater. 2003;19(6):449–57. doi: 10.1016/S0109-5641(02)00102-1.
    1. Imazato S, Kuramoto A, Takahashi Y, Ebisu S, Peters MC. In vitro antibacterial effects of the dentin primer of Clearfil Protect Bond. Dent Mater. 2006;22:527–32. doi: 10.1016/j.dental.2005.05.009.
    1. Izutani N, Imazato S, Nakajo K, Takahashi N, Takahashi Y, Ebisu S, et al. Effects of the antibacterial monomer 12-methacryloyloxydodecylpyridinium bromide (MDPB) on bacterial viability and metabolism. Eur J Oral Sci. 2011;119:175–81. doi: 10.1111/j.1600-0722.2011.00817.x.
    1. Imazato S, Kaneko T, Takahashi Y, Noiri Y, Ebisu S. In vivo antibacterial effects of dentin primer incorporating MDPB. Oper Dent. 2004;29(4):369–75.
    1. Tziafas D, Koliniotou-Koumpia E, Tziafa C, Papadimitriou S. Effects of a new antibacterial adhesive on the repair capacity of the pulp-dentine complex in infected teeth. Int Endod J. 2007;40(1):58–66. doi: 10.1111/j.1365-2591.2006.01183.x.
    1. Chan AW, Tetzlaff JM, Gøtzsche PC, Altman DG, Mann H, Berlin JA, et al. SPIRIT 2013 explanation and elaboration: guidance for protocols of clinical trials. BMJ. 2013;346:e7586. doi: 10.1136/bmj.e7586.
    1. Mertz-Fairhurst EJ, Curtis JW, Jr, Ergle JW, Rueggeberg FA, Adair SM. Ultraconservative and cariostatic sealed restorations: results at year 10. J Am Dent Assoc. 1998;129(1):55–66. doi: 10.14219/jada.archive.1998.0022.
    1. Farsi N, Alamoudi N, Balto K, Al MA. Clinical assessment of mineral trioxide aggregate (MTA) as direct pulp capping in young permanent teeth. J Clin Pediatr Dent. 2006;31(2):72–6. doi: 10.17796/jcpd.31.2.n462281458372u64.
    1. Ricketts DN, Kidd EA, Innes N, Clarkson J. Complete or ultraconservative removal of decayed tissue in unfilled teeth. Cochrane Database Syst Rev. 2006;3:CD003808.
    1. Torabinejad M, Anderson P, Bader J, Brown LJ, Chen LH, Goodacre CJ, et al. Outcomes of root canal treatment and restoration, implant-supported single crowns, fixed partial dentures, and extraction without replacement: a systematic review. J Prosthet Dent. 2007;98(4):285–311. doi: 10.1016/S0022-3913(07)60102-4.
    1. Bogen G, Kim JS, Bakland LK. Direct pulp capping with mineral trioxide aggregate: an observational study. J Am Dent Assoc. 2008;139(3):305–15. doi: 10.14219/jada.archive.2008.0160.
    1. Dammaschke T, Leidinger J, Schäfer E. Long-term evaluation of direct pulp capping--treatment outcomes over an average period of 6.1 years. Clin Oral Investig. 2010;14(5):559–67. doi: 10.1007/s00784-009-0326-9.
    1. Mente J, Geletneky B, Ohle M, Koch MJ, Friedrich Ding PG, Wolff D, et al. Mineral trioxide aggregate or calcium hydroxide direct pulp capping: an analysis of the clinical treatment outcome. J Endod. 2010;36(5):806–13. doi: 10.1016/j.joen.2010.02.024.
    1. Maltz M, Alves LS, Jardim JJ, Moura Mdos S, de Oliveira EF. Incomplete caries removal in deep lesions: a 10-year prospective study. Am J Dent. 2011;24(4):211–4.
    1. Willershausen B, Willershausen I, Ross A, Velikonja S, Kasaj A, Blettner M. Retrospective study on direct pulp capping with calcium hydroxide. Quintessence Int. 2011;42(2):165–71.
    1. Chernick MR, Liu CY. The saw-toothed behavior of power versus sample size and software solutions: single binomial proportion using exact methods. Am Stat. 2002;56:149–55. doi: 10.1198/000313002317572835.
    1. Fleiss JL. Statistical methods for rates and proportions. 2. New York: John Wiley & Sons, Inc; 1981. pp. 24–6.
    1. Thomas RG, Conlon M. Sample size determination based on Fisher’s exact test for use in 2 x 2 comparative trials with low event rates. Control Clin Trials. 1992;13(2):134–47. doi: 10.1016/0197-2456(92)90019-V.
    1. Orstavik D, Kerekes K, Eriksen HM. The periapical index: a scoring system for radiographic assessment of apical periodontitis. Endod Dent Traumatol. 1986;2(1):20–34. doi: 10.1111/j.1600-9657.1986.tb00119.x.
    1. Panayotov I, Terrer E, Salehi H, Tassery H, Yachouh J, Cuisinier FJ, et al. In vitro investigation of fluorescence of carious dentin observed with a Soprolife® camera. Clin Oral Investig. 2013;17:757–63. doi: 10.1007/s00784-012-0770-9.
    1. Hickel R, Roulet JF, Bayne S, Heintze SD, Mjör IA, Peters M, et al. Recommendations for conducting controlled clinical studies of dental restorative materials. Clin Oral Investig. 2007;11(1):5–33. doi: 10.1007/s00784-006-0095-7.
    1. Hickel R, Peschke A, Tyas M, Mjör I, Bayne S, Peters M, et al. FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig. 2010;14(4):349–66. doi: 10.1007/s00784-010-0432-8.
    1. Schulz KF, Altman DG, Moher D. CONSORT Group. CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med. 2010;152(11):726–32. doi: 10.7326/0003-4819-152-11-201006010-00232.

Source: PubMed

Спонсоры и соавторы

Заболевания

Медикаментозные вмешательства

Подписаться