Selective carious tissue removal using subjective criteria or polymer bur: study protocol for a randomised controlled trial (SelecCT)

Falk Schwendicke, Soraya Leal, Peter Schlattmann, Sebastian Paris, Ana Paula Dias Ribeiro, Marta Gomes Marques, Leandro Augusto Hilgert, Falk Schwendicke, Soraya Leal, Peter Schlattmann, Sebastian Paris, Ana Paula Dias Ribeiro, Marta Gomes Marques, Leandro Augusto Hilgert

Abstract

Introduction: Selective (incomplete/partial) carious tissue removal is suitable for treating deep carious lesions in teeth with vital, asymptomatic pulps. In the periphery of a cavity, removal to hard dentin is performed, while in pulpo-proximal areas, leathery or soft dentin is left to avoid pulp exposure. As the decision of what contains 'soft' or 'leathery' dentin is subjective, using self-limiting burs which help to standardise the hardness of the remaining dentin, has been suggested to increase the reliability of carious tissue removal. The trial compares subjectively measured selective carious tissue removal in deep lesions in primary teeth with objectively measured selective removal with a self-limiting bur (Polybur, Komet).

Methods and analysis: A community-based single-blind clustered randomised controlled superiority trial nested into a larger evaluation is performed. Recruitment for this trial has been concluded. We have recruited 115 children aged 6-8 years with ≥1 vital primary molar with a deep dentin lesion. The unit of randomisation was the child, with all eligible molars per child treated identically. Treatment was performed in a mobile dental unit. Subjective and objective carious tissue removal was performed at random. Teeth were restored using glass ionomer cement (Equia Forte, GC). Our primary outcome will be the time until complications occur, evaluated via multilevel survival analysis. Secondary outcomes will be the time until extraction is needed, subjective satisfaction of the child with the treatment (measured using a Likert scale) and cost-effectiveness. Re-examination will be performed after 12, 24 and 36 months (the final examination is expected in 2020).

Ethics and dissemination: This trial has been approved by the Ethics Committee of the Health Sciences of the University of Brasília (CAAE 51310415.0.0000.0030). Trial results will be published in peer-reviewed journals and presented on conferences.

Trial registration number: NCT02754466.

Keywords: caries; clinical trials; dental; oral medicine; paediatric dentistry.

Conflict of interest statement

Competing interests: None declared.

© Author(s) (or their employer(s)) 2018. Re-use permitted under CC BY-NC. No commercial re-use. See rights and permissions. Published by BMJ.

Figures

Figure 1
Figure 1
Flow chart of the study.

References

    1. Ricketts D, Lamont T, Innes NP, et al. . Operative caries management in adults and children. Cochrane Database Syst Rev 2013;28:CD003808 10.1002/14651858.CD003808.pub3
    1. Schwendicke F, Stolpe M, Innes N. Conventional treatment, Hall Technique or immediate pulpotomy for carious primary molars: a cost-effectiveness analysis. Int Endod J 2016;49:817–26. 10.1111/iej.12537
    1. Oong EM, Griffin SO, Kohn WG, et al. . The effect of dental sealants on bacteria levels in caries lesions. J Am Dent Assoc 2008;139:271–8. 10.14219/jada.archive.2008.0156
    1. Schwendicke F, Meyer-Lueckel H, Dörfer C, et al. . Failure of incompletely excavated teeth--a systematic review. J Dent 2013;41:569–80. 10.1016/j.jdent.2013.05.004
    1. Schwendicke F, Kern M, Meyer-Lueckel H, et al. . Fracture resistance and cuspal deflection of incompletely excavated teeth. J Dent 2014;42:107–13. 10.1016/j.jdent.2013.12.003
    1. Schwendicke F, Kern M, Blunck U, et al. . Marginal integrity and secondary caries of selectively excavated teeth in vitro. J Dent 2014;42:1261–8. 10.1016/j.jdent.2014.08.002
    1. Hevinga MA, Opdam NJ, Frencken JE, et al. . Does incomplete caries removal reduce strength of restored teeth? J Dent Res 2010;89:1270–5. 10.1177/0022034510377790
    1. Schwendicke F, Paris S, Tu YK. Effects of using different criteria for caries removal: a systematic review and network meta-analysis. J Dent 2015;43:1–15. 10.1016/j.jdent.2014.10.004
    1. Boston DW. New device for selective dentin caries removal. Quintessence Int 2003;34:678–85.
    1. Meller C, Welk A, Zeligowski T, et al. . Comparison of dentin caries excavation with polymer and conventional tungsten carbide burs. Quintessence Int 2007;38:565–9.
    1. Prabhakar A, Kiran NK. Clinical evaluation of polyamide polymer burs for selective carious dentin removal. J Contemp Dent Pract 2009;10:26–34.
    1. Silva NR, Carvalho RM, Pegoraro LF, et al. . Evaluation of a self-limiting concept in dentinal caries removal. J Dent Res 2006;85:282–6. 10.1177/154405910608500315
    1. Lee E, Wei LJ, Amato DA. Cox-type regression analysis for large number of small groups of correlated failure time observation In: Klein JP, Goel PK, eds Survival Analysis: State of The Art. Dordrect: Kluwer Academic, 1992:227–47.
    1. Xie T, Waksman J. Design and sample size estimation in clinical trials with clustered survival times as the primary endpoint. Stat Med 2003;22:2835–46. 10.1002/sim.1536
    1. Campbell MJ, Walter SJ, Design H. Analyse and Report Cluster Randomised Trials in Medicine and Health Related Research. Chichester: Wiley, 2014.
    1. de Souza AL, van der Sanden WJ, Leal SC, et al. . The Caries Assessment Spectrum and Treatment (CAST) index: face and content validation. Int Dent J 2012;62:270–6. 10.1111/j.1875-595X.2012.00121.x
    1. Guo S. Survival Analysis. oxford: Oxford University Press, 2010.
    1. Schafer JL. Multiple imputation: a primer. Stat Methods Med Res 1999;8:3–15. 10.1177/096228029900800102
    1. Tickle M, Milsom K, King D, et al. . The fate of the carious primary teeth of children who regularly attend the general dental service. Br Dent J 2002;192:219–23. 10.1038/sj.bdj.4801338
    1. Innes NP, Evans DJ, Stirrups DR. The Hall Technique; a randomized controlled clinical trial of a novel method of managing carious primary molars in general dental practice: acceptability of the technique and outcomes at 23 months. BMC Oral Health 2007;7:18 10.1186/1472-6831-7-18
    1. Santamaria RM, Innes NP, Machiulskiene V, et al. . Acceptability of different caries management methods for primary molars in a RCT. Int J Paediatr Dent 2015;25:9–17. 10.1111/ipd.12097
    1. Schwendicke F, Frencken JE, Bjørndal L, et al. . Managing carious lesions: consensus recommendations on carious tissue removal. Adv Dent Res 2016;28:58–67. 10.1177/0022034516639271
    1. Schwendicke F, Meyer-Lueckel H, Dörfer C, et al. . Attitudes and behaviour regarding deep dentin caries removal: a survey among German dentists. Caries Res 2013;47:566–73. 10.1159/000351662
    1. Schwendicke F, Stangvaltaite L, Holmgren C, et al. . Dentists' attitudes and behaviour regarding deep carious lesion management: a multi-national survey. Clin Oral Investig 2017;21:191–8. 10.1007/s00784-016-1776-5
    1. Bowen JL, Mathu-Muju KR, Nash DA, et al. . Pediatric and general dentists' attitudes toward pulp therapy for primary teeth. Pediatr Dent 2012;34:210–5.
    1. Petersen PE, Bourgeois D, Ogawa H, et al. . The global burden of oral diseases and risks to oral health. Bull World Health Organ 2005;83:661–9.
    1. Ridell K, Olsson H, Mejàre I. Unrestored dentin caries and deep dentin restorations in Swedish adolescents. Caries Res 2008;42:164–70. 10.1159/000128560
    1. Schwendicke F, Paris S, Stolpe M. Cost-effectiveness of caries excavations in different risk groups - a micro-simulation study. BMC Oral Health 2014;14:153 10.1186/1472-6831-14-153
    1. Lamont T, Schwendicke F, Innes N. Why we need a core outcome set for trials of interventions for prevention and management of caries. Evid Based Dent 2015;16:66–8. 10.1038/sj.ebd.6401109

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