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BMC Oral Health
Published in: BMC Oral Health 1/2017

Open Access 01-12-2017 | Study protocol

Effectiveness of conventional treatment using bulk-fill composite resin versus Atraumatic Restorative Treatments in primary and permanent dentition: a pragmatic randomized clinical trial

Authors: Isabel Cristina Olegário, Daniela Hesse, Marcelo Bönecker, José Carlos Pettorossi Imparato, Mariana Minatel Braga, Fausto Medeiros Mendes, Daniela Prócida Raggio

Published in: BMC Oral Health | Issue 1/2017

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Abstract

Background

Clinical studies are being conducted in less strict conditions in order to establish an adequate scientific basis for decision making. The aim of this pragmatic randomized clinical trial is to evaluate the effectiveness of single and multiple-surfaces restorations performed following the Atraumatic Restorative Treatment (ART) premises compared with Conventional Treatment (CT) using bulk fill composite restorations in primary and permanent teeth.

Methods/design

A total of 1,214 5-to-13 year-old children with at least one single or multiple-surface dentin caries lesion in primary or permanent molars will be selected in public schools of Barueri-SP, Brazil. The participants will be randomly assigned into 2 groups: CT (caries removal with bur and restoration performed with Scotchbond™ Universal Adhesive system associated with Filtek Bulk Fill – 3 M/ESPE) and ART (Caries removal with hand instruments and restoration with high viscosity glass ionomer cement Ketac Molar Easy Mix – 3 M/ESPE). Ten untrained dentists will perform the treatment in in dental offices located at public schools. The restorations will be evaluated after 6, 12 and 24 months by an independent trained and calibrated examiner. The restoration and tooth survival, the cost-effectiveness analysis between the two groups and the operators’ preferences regarding the techniques will be also evaluated. Kaplan-Meier survival analysis and log-rank test will be applied for the restoration and tooth survival. All the average event rates in the two groups will be modelled and compared with a Cox proportional hazard shared frailty model since there is an operator-cluster effect. The significance level for all analyses will be 5 %.

Discussion

Our hypothesis is that despite similar expected effectiveness between ART using high viscosity GIC and conventional treatment using bulk fill composite resin when treating single or multiple-surface in posterior primary and permanent teeth, ART will present superior cost-effectiveness. The results of this trial will support decision-making by clinicians and policy makers.

Trial registration

NCT02568917. Registered on May 10th 2015.
Appendix
Available only for authorised users
Literature
1.
2.
Frencken JE, van’t Hof MA, Taifour D, Al-Zaher I. Effectiveness of ART and traditional amalgam approach in restoring single-surface cavities in posterior teeth of permanent dentitions in school children after 6.3 years. Community Dent Oral Epidemiol. 2007;35(3):207–14.CrossRefPubMed
3.
Pani SC, Abbassi MFA, Saffan AD, Sumait MAA, Shakir AN. Factors influencing Saudi dental students’ preference of amalgam or composite for posterior dental restorations. S J Oral Sci. 2014;1(1):30–6.CrossRef
4.
Ericson D, Kidd EAM, McComb D, Mjor I, Noack MJ. Minimally invasive dentistry—concept and techniques in cariology. Oral Health Prev Dent. 2003;1:59–72.PubMed
5.
Czarnecka B. The use of ART technique in modern dental practice: a personal view. J Dent. 2006;34:620.CrossRef
6.
Smales RJ, Yip HK. The atraumatic restorative treatment (ART) approach for the management of dental caries. Quintessence Int. 2002;33:427–32.PubMed
7.
Ismail A. Minimal intervention techniques for dental caries. J Public Health Dent. 1996;56:155–60.CrossRefPubMed
8.
Phantumvanit P, Songpaisan Y, Pilot T, Frencken JE. Atraumatic restorative treatment (ART): a three-year community field trial in Thailand – survival of one-surface restorations in the permanent dentition. J Public Health Dent. 1996;56:141–5.CrossRefPubMed
9.
van Dijken JW, Pallesen U. Randomized 3-year clinical evaluation of Class I and II posterior resin restorations placed with a bulk-fill resin composite and a one-step self-etching adhesive. J Adhes Dent. 2015;17(1):81–8.PubMed
10.
de Amorim RG, Leal SC, Frencken JE. Survival of atraumatic restorative treatment (ART) sealants and restorations: a meta-analysis. Clin Oral Investig. 2012;16(2):429–41.CrossRefPubMed
11.
WHO – World Health Organization. WHO Oral Health Data Bank. Geneva: World Health Organization; 2002.
12.
Gruebbel AO. Post-War implications of fluorine and dental health: from the viewpoint of public health dentistry. Am J Public Health Nations Health. 1944;34(3):244–7.CrossRefPubMedPubMedCentral
13.
Löe H, von der Fehr FR, Schiött CR. Inhibition of experimental caries by plaque prevention: the effect of clorhexidine mouthrinses. Scand J Dent Res. 1972;80:1–9.PubMed
14.
Kornman KS, Löe H. The role of local factors in the etiology of periodontal diseases. Periodontol 2000. 1993;2(1):83–97.CrossRefPubMed
15.
Frencken JE, Holmgren CJ. How effective is ART in the management of dental caries? Community Dent Oral Epidemiol. 1999;27(6):423–30.CrossRefPubMed
16.
Roeleveld AC, Van Amerongen WE, Mandari GJ. Influence of residual caries and cervical gaps on the survival rate of Class II glass ionomer restorations. Eur Arch Paediatr Dent. 2006;7(2):85–91.CrossRefPubMed
17.
Bonifácio CC, Hesse D, Raggio DP, Bönecker M, van Loveren C, van Amerongen WE. The effect of GIC-brand on the survival rate of proximal-ART restorations. Int J Paediatr Dent. 2013;23(4):251–8.CrossRefPubMed
18.
Takanashi Y, Penrod JR, Lund JP, Feine JS. A cost comparison of mandibular two-implant overdenture and conventional denture treatment. Int J Prosthodont. 2004;17:181–6.PubMed
19.
Kawai Y, Murakami H, Takanashi Y, Lund JP, Feine JS. Efficient resource use in simplified complete denture fabrication. J Prosthodont. 2010;19:512–6.CrossRefPubMed
20.
van Dijken JW, Pallesen U. A randomized controlled three year evaluation of “bulk-filled” posterior resin restorations based on stress decreasing resin technology. Dent Mater. 2014;30(9):e245–51.CrossRefPubMed
21.
Elixhauser A, Halpern M, Schmier J, Luce BR. Health care CBA and CEA from 1991 to 1996: an updated bibliography. Med Care. 1998;36:1–9.CrossRef
22.
Hesse D, Bonifácio CC, Guglielmi CA, Bönecker M, van Amerongen WE, Raggio DP. Bilayer technique and nano-filled coating increase success of approximal ART restorations: a randomized clinical trial. Int J Paediatr Dent. 2015. doi:10.​1111/​ipd.​12194.PubMed
23.
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.CrossRefPubMedPubMedCentral
24.
Bonifácio CC, Hesse D, Bönecker M, Van Loveren C, Van Amerongen WE, Raggio DP. A preliminary clinical trial using flowable glass-ionomer cement as a liner in proximal-ART restorations: the operator effect. Med Oral Patol Oral Cir Bucal. 2013;18(3):529–32.CrossRef
25.
Boon CP, Visser NL, Kemoli AM, van Amerongen WE. ART class II restoration loss in primary molars: re-restoration or not? Eur Arch Paediatr Dent. 2010;11:228–31.CrossRefPubMed
26.
Mickenautsch S, Yengopal V, Banerjee A. Atraumatic restorative treatment versus amalgam restoration longevity: a systematic review. Clin Oral Invest. 2010;14:233–40.CrossRef
27.
Raggio DP, Hesse D, Lenzi TL, Guglielmi CA, Braga MM. Is Atraumatic restorative treatment an option for restoring occlusoproximal caries lesions in primary teeth? A systematic review and meta-analysis. Int J Paediatr Dent. 2013;23(6):435–43.PubMed
Metadata
Title
Effectiveness of conventional treatment using bulk-fill composite resin versus Atraumatic Restorative Treatments in primary and permanent dentition: a pragmatic randomized clinical trial
Authors
Isabel Cristina Olegário
Daniela Hesse
Marcelo Bönecker
José Carlos Pettorossi Imparato
Mariana Minatel Braga
Fausto Medeiros Mendes
Daniela Prócida Raggio
Publication date
01-12-2017
Publisher
BioMed Central
Published in
BMC Oral Health / Issue 1/2017
Electronic ISSN: 1472-6831
DOI
https://doi.org/10.1186/s12903-016-0260-6

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