Efficacy of composite versus ceramic inlays and onlays: study protocol for the CECOIA randomized controlled trial

Trials

Jean-Pierre Attal³  Cathy Nabet²  Louis Maman³  Florence Chemla³  Aurore Caumont-Prim¹  Jean-François Leforestier¹  Renaud Boyer¹  Inès Khabthani Ben Jaballah¹  Alexandre Gaucher⁵  Christian Moussally⁵  Stéphane Cazier⁵  Olivier Chabreron²  Karim Nasr²  Cyrille Fonteneau⁵  Caroline Prot⁵  Hélène Fron Chabouis⁴ 

[1] AP-HP, Hôpital Européen Georges-Pompidou (HEGP), Institut National de la Santé et de la Recherche Médicale (INSERM), UMR S872/20, Paris 75015, France;Pôle Odontologie, Hotel-Dieu Saint-Jacques, Toulouse 31059, France;Service d’Odontologie, Assistance Publique – Hôpitaux de Paris (AP-HP), Hôpital Charles Foix, Ivry-sur-Seine 94200, France;Ecole doctorale Galillée, Université Paris 13, Sorbonne Paris Cité, Villetaneuse 93430, France;Private Dental Practice, Paris, France

关键词: Dental restoration wear;    Dental restoration failure;    Dental prosthesis;    CAD/CAM;    Survival analysis;    Ceramic;    Composite resins;    Inlays;    Dental caries;   

Others  :  1093125
DOI  :  10.1186/1745-6215-14-278

 received in 2012-11-20, accepted in 2013-08-13,  发布年份 2013

【 摘 要 】

Background

Dental caries is a common disease and affects many adults worldwide. Inlay or onlay restoration is widely used to treat the resulting tooth substance loss. Two esthetic materials can be used to manufacture an inlay/onlay restoration of the tooth: ceramic or composite. Here, we present the protocol of a multicenter randomized controlled trial (RCT) comparing the clinical efficacy of both materials for tooth restoration. Other objectives are analysis of overall quality, wear, restoration survival and prognosis.

Methods

The CEramic and COmposite Inlays Assessment (CECOIA) trial is an open-label, parallel-group, multicenter RCT involving two hospitals and five private practices. In all, 400 patients will be included. Inclusion criteria are adults who need an inlay/onlay restoration for one tooth (that can be isolated with use of a dental dam and has at least one intact cusp), can tolerate restorative procedures and do not have severe bruxism, periodontal or carious disease or poor oral hygiene. The decayed tissue will be evicted, the cavity will be prepared for receiving an inlay/onlay and the patient will be randomized by use of a centralized web-based interface to receive: 1) a ceramic or 2) composite inlay or onlay. Treatment allocation will be balanced (1:1). The inlay/onlay will be adhesively luted. Follow-up will be for 2 years and may be extended; two independent examiners will perform the evaluations. The primary outcome measure will be the score obtained with use of the consensus instrument of the Fédération Dentaire Internationale (FDI) World Dental Federation. Secondary outcomes include this instrument’s items, inlay/onlay wear, overall quality and survival of the inlay/onlay. Data will be analyzed by a statistician blinded to treatments and an adjusted ordinal logistic regression model will be used to compare the efficacy of both materials.

Discussion

For clinicians, the CECOIA trial results may help with evidence-based recommendations concerning the choice of materials for inlay/onlay restoration. For patients, the results may lead to improvement in long-term restoration. For researchers, the results may provide ideas for further research concerning inlay/onlay materials and prognosis.

This trial is funded by a grant from the French Ministry of Health.

Trial registration

ClinicalTrials.gov Identifier:NCT01724827

【 授权许可】

   
2013 Fron Chabouis et al.; licensee BioMed Central Ltd.

【 参考文献 】

• [1]Petersen PE: The World Oral Health Report 2003: Continuous Improvement of Oral Health in the 21st century - The Approach of the WHO Global Oral Health Programme. Geneva: WHO; 2003.
• [2]Bagramian RA, Garcia-Godoy F, Volpe AR: The global increase in dental caries. A pending public health crisis. Am J Dent 2009, 22:3-8.
• [3]BIO Intelligence Service: Study on the Potential for Reducing Mercury Pollution from Dental Amalgam and Batteries. Paris: BIO Intelligence Service: Final report prepared for the European Commission - DG ENV; 2012.
• [4]Edelhoff D, Sorensen JA: Tooth structure removal associated with various preparation designs for posterior teeth. Int J Periodontics Restorative Dent 2002, 22:241-249.
• [5]McGill S, Holmes J: The 7/8 crown: a lost art. Oper Dent 2012, 37:453-457.
• [6]Chen X, Chadwick TC, Wilson RM, Hill RG, Cattell MJ: Crystallization and flexural strength optimization of fine-grained leucite glass-ceramics for dentistry. Dent Mater 2011, 27:1153-1161.
• [7]Lin WS, Ercoli C, Feng C, Morton D: The effect of core material, veneering porcelain, and fabrication technique on the biaxial flexural strength and weibull analysis of selected dental ceramics. J Prosthodont 2012, 21:353-362.
• [8]Drummond JL: Degradation, fatigue, and failure of resin dental composite materials. J Dent Res 2008, 87:710-719.
• [9]Ansong R, Flinn B, Chung KH, Mancl L, Ishibe M, Raigrodski AJ: Fracture toughness of heat-pressed and layered ceramics. J Prosthet Dent 2013, 109:234-240.
• [10]Magne P, Belser UC: Porcelain versus composite inlays/onlays: effects of mechanical loads on stress distribution, adhesion, and crown flexure. Int J Periodontics Restorative Dent 2003, 23:543-555.
• [11]Yamanel K, Caglar A, Gulsahi K, Ozden UA: Effects of different ceramic and composite materials on stress distribution in inlay and onlay cavities: 3-D finite element analysis. Dent Mater J 2009, 28:661-670.
• [12]Mormann WH, Stawarczyk B, Ender A, Sener B, Attin T, Mehl A: Wear characteristics of current aesthetic dental restorative CAD/CAM materials: two-body wear, gloss retention, roughness and Martens hardness. J Mech Behav Biomed Mater 2013, 20:113-125.
• [13]Gladys S, Van Meerbeek B, Inokoshi S, Willems G, Braem M, Lambrechts P, Vanherle G: Clinical and semiquantitative marginal analysis of four tooth-coloured inlay systems at 3 years. J Dent 1995, 23:329-338.
• [14]Krämer N, Frankenberger R: Leucite-reinforced glass ceramic inlays after six years: wear of luting composites. Oper Dent 2000, 25:466-472.
• [15]Darmani H, Al-Hiyasat AS, Milhem MM: Cytotoxicity of dental composites and their leached components. Quintessence Int 2007, 38:789-795.
• [16]Durner J, Spahl W, Zaspel J, Schweikl H, Hickel R, Reichl FX: Eluted substances from unpolymerized and polymerized dental restorative materials and their Nernst partition coefficient. Dent Mater 2010, 26:91-99.
• [17]St John KR: Biocompatibility of dental materials. Dent Clin North Am 2007, 51:747-760. viii
• [18]Wataha JC, Rueggeberg FA, Lapp CA, Lewis JB, Lockwood PE, Ergle JW, Mettenburg DJ: In vitro cytotoxicity of resin-containing restorative materials after aging in artificial saliva. Clin Oral Investig 1999, 3:144-149.
• [19]Bakopoulou AA, Triviai IN, Tsiftsoglou AS, Garefis PD: In vitro assessment of cytotoxicity of resin-based dental restorative materials on WEHI 13 var fibroblasts. Int J Prosthodont 2006, 19:13-16.
• [20]Manhart J, Scheibenbogen-Fuchsbrunner A, Chen HY, Hickel R: A 2-year clinical study of composite and ceramic inlays. Clin Oral Investig 2000, 4:192-198.
• [21]Manhart J, Chen HY, Neuerer P, Scheibenbogen-Fuchsbrunner A, Hickel R: Three-year clinical evaluation of composite and ceramic inlays. Am J Dent 2001, 14:95-99.
• [22]Magne P, Knezevic A: Simulated fatigue resistance of composite resin versus porcelain CAD/CAM overlay restorations on endodontically treated molars. Quintessence Int 2009, 40:125-133.
• [23]Magne P, Knezevic A: Influence of overlay restorative materials and load cusps on the fatigue resistance of endodontically treated molars. Quintessence Int 2009, 40:729-737.
• [24]Frankenberger R, Reinelt C, Petschelt A, Krämer N: Operator vs. material influence on clinical outcome of bonded ceramic inlays. Dent Mater 2009, 25:960-968.
• [25]Fasbinder DJ, Dennison JB, Heys DR, Lampe K: The clinical performance of CAD/CAM-generated composite inlays. J Am Dent Assoc 2005, 136:1714-1723.
• [26]Thordrup M, Isidor F, Hörsted-Bindslev P: A prospective clinical study of indirect and direct composite and ceramic inlays: ten-year results. Quintessence Int 2006, 37:139-144.
• [27]Fron Chabouis H, Smail-Faugeron V, Attal J: Clinical efficacy of composite vs ceramic for inlays and onlays - a systematic review. Submitted for publication;
• [28]Hickel R, Roulet JF, Bayne S, Heintze SD, Mjor IA, Peters M, Rousson V, Randall R, Schmalz G, Tyas M, Vanherle G: Recommendations for conducting controlled clinical studies of dental restorative materials. Science Committee Project 2/98–FDI World Dental Federation study design (Part I) and criteria for evaluation (Part II) of direct and indirect restorations including onlays and partial crowns. J Adhes Dent 2007, 9(1):121-147.
• [29]Bayne SC, Schmalz G: Reprinting the classic article on USPHS evaluation methods for measuring the clinical research performance of restorative materials. Clin Oral Investig 2005, 9:209-214.
• [30]Ryge G: The California dental association quality evaluation system: a standard for self-assessment. In Quality Evaluation of Dental Restorations: Criteria for Placement and Replacement. Edited by Anusavice KJ. Chicago: Quintessence Publishing; 1989:273-290.
• [31]Pallesen U, van Dijken JW: An 8-year evaluation of sintered ceramic and glass ceramic inlays processed by the Cerec CAD/CAM system. Eur J Oral Sci 2000, 108:239-246.
• [32]Qvist V, Johannessen L, Bruun M: Progression of approximal caries in relation to iatrogenic preparation damage. J Dent Res 1992, 71:1370-1373.
• [33]Lussi A, Gygax M: Iatrogenic damage to adjacent teeth during classical approximal box preparation. J Dent 1998, 26:435-441.
• [34]Krifka S, Anthofer T, Fritzsch M, Hiller KA, Schmalz G, Federlin M: Ceramic inlays and partial ceramic crowns: influence of remaining cusp wall thickness on the marginal integrity and enamel crack formation in vitro. Oper Dent 2009, 34:32-42.
• [35]Fennis WM, Kuijs RH, Barink M, Kreulen CM, Verdonschot N, Creugers NH: Can internal stresses explain the fracture resistance of cusp-replacing composite restorations?Eur. J Oral Sci 2005, 113:443-448.
• [36]Fennis WM, Kuijs RH, Kreulen CM, Verdonschot N, Creugers NH: Fatigue resistance of teeth restored with cuspal-coverage composite restorations. Int J Prosthodont 2004, 17:313-317.
• [37]Fron H, Vergnes JN, Moussally C, Cazier S, Simon AL, Chieze JB, Savard G, Tirlet G, Attal JP: Effectiveness of a new one-step self-etch adhesive in the restoration of non-carious cervical lesions: 2-year results of a randomized controlled practice-based study. Dent Mater 2011, 27:304-312.
• [38]Hickel R, Peschke A, Tyas M, Mjör I, Bayne S, Peters M, Hiller KA, Randall R, Vanherle G, Heintze SD: FDI World Dental Federation: clinical criteria for the evaluation of direct and indirect restorations-update and clinical examples. Clin Oral Investig 2010, 14:349-366.
• [39]Zhao YD, Rahardja D, Qu Y: Sample size calculation for the Wilcoxon-Mann–Whitney test adjusting for ties. Stat Med 2008, 27:462-468.
• [40]Frankenberger R, Taschner M, Garcia-Godoy F, Petschelt A, Krämer N: Leucite-reinforced glass ceramic inlays and onlays after 12 years. J Adhes Dent 2008, 10:393-398.
• [41]Krämer N, Taschner M, Lohbauer U, Petschelt A, Frankenberger R: Totally bonded ceramic inlays and onlays after eight years. J Adhes Dent 2008, 10:307-314.
• [42]Guess PC, Strub JR, Steinhart N, Wolkewitz M, Stappert CF: All-ceramic partial coverage restorations–midterm results of a 5-year prospective clinical splitmouth study. J Dent 2009, 37:627-637.
• [43]Heintze SD, Cavalleri A, Forjanic M, Zellweger G, Rousson V: Wear of ceramic and antagonist–a systematic evaluation of influencing factors in vitro. Dent Mater 2008, 24:433-449.
• [44]Manhart J, Neuerer P, Scheibenbogen-Fuchsbrunner A, Hickel R: Three-year clinical evaluation of direct and indirect composite restorations in posterior teeth. J Prosthet Dent 2000, 84:289-296.
• [45]Peumans M, De Munck J, Van Landuyt K, Poitevin A, Lambrechts P, Van Meerbeek B: Two-year clinical evaluation of a self-adhesive luting agent for ceramic inlays. J Adhes Dent 2010, 12:151-161.
• [46]Sjogren G, Molin M, van Dijken JW: A 10-year prospective evaluation of CAD/CAM-manufactured (Cerec) ceramic inlays cemented with a chemically cured or dual-cured resin composite. Int J Prosthodont 2004, 17:241-246.
• [47]Moncada G, Martin J, Fernández E, Hempel MC, Mjör IA, Gordan VV: Sealing, refurbishment and repair of Class I and Class II defective restorations: a three-year clinical trial. J Am Dent Assoc 2009, 140:425-432.
• [48]Vierron E, Giraudeau B: Sample size calculation for multicenter randomized trial: taking the center effect into account. Contemp Clin Trials 2007, 28:451-458.
• [49]Haute autorité de Santé: Méthodes Quantitatives pour Évaluer les Interventions Visant à Améliorer les Pratiques. Saint-Denis la Plaine: Haute Autorité de Santé; 2007.
• [50]Fleming TR: Addressing missing data in clinical trials. Ann Intern Med 2011, 154:113-117.
• [51]Fron Chabouis H, Chabouis F, Gillaizeau F, Durieux P, Chatellier G, Ruse ND, Attal JP: Randomization in clinical trials: stratification or minimization?. Clin Oral Investig: The HERMES free simulation software; 2013.
• [52]Fron H: Performances comparées des inlays-onlays composites ou céramiques réalisés par CFAO directe dans le cadre des pertes de substance postérieures moyennes à importantes: essai clinique randomisé multicentrique: élaboration du protocole. : Paris Descartes University; 2010. [Master’s thesis]
• [53]Austin PC, Manca A, Zwarenstein M, Juurlink DN, Stanbrook MB: A substantial and confusing variation exists in handling of baseline covariates in randomized controlled trials: a review of trials published in leading medical journals. J Clin Epidemiol 2010, 63:142-153.
• [54]White IR, Horton NJ, Carpenter J, Pocock SJ: Strategy for intention to treat analysis in randomised trials with missing outcome data. BMJ 2011, 342:d40.
• [55]Yu LM, Chan AW, Hopewell S, Deeks JJ, Altman DG: Reporting on covariate adjustment in randomised controlled trials before and after revision of the 2001 CONSORT statement: a literature review. Trials 2010, 11:59. BioMed Central Full Text
• [56]Pocock SJ, Assmann SE, Enos LE, Kasten LE: Subgroup analysis, covariate adjustment and baseline comparisons in clinical trial reporting: current practice and problems. Stat Med 2002, 21:2917-2930.
• [57]ICH Steering Committee: ICH Harmonised Tripartite Guideline: Statistical principles for clinical trials. International Conference on Harmonisation E9 Expert Working Group. Stat Med 1999, 18:1905-1942.
• [58]Schulz KF, Altman DG, Moher D, CONSORT Group: CONSORT 2010 statement: updated guidelines for reporting parallel group randomized trials. Ann Intern Med 2010, 152:726-732.
• [59]Boutron I, Moher D, Altman DG, Schulz KF, Ravaud P, CONSORT Group: Extending the CONSORT statement to randomized trials of nonpharmacologic treatment: explanation and elaboration. Ann Intern Med 2008, 148:295-309.
• [60]Hopewell S, Clarke M, Moher D, Wager E, Middleton P, Altman DG, Schulz KF, and the CONSORT Group: CONSORT for reporting randomised trials in journal and conference abstracts. Lancet 2008, 371:281-283.
• [61]Chan AW, Tetzlaff JM, Altman DG, Laupacis A, Gøtzsche PC, Krleža-Jerić K, Hróbjartsson A, Mann H, Dickersin K, Berlin JA, Doré CJ, Parulekar WR, Summerskill WS, Groves T, Schulz KF, Sox HC, Rockhold FW, Rennie D, Moher D: SPIRIT 2013 statement: defining standard protocol items for clinical trials. Ann Intern Med 2013, 158:200-207.