Clinical trial NCT04491981: Restoration Repairs Using Composite Resin Versus Glass Ionomer in Primary Molars: a Randomized Clinical Trial
Official title: Longevity of Restoration Repairs Using Composite Resin Versus High Viscosity Glass Ionomer in Primary Molars: Randomized Clinical Trial
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Dental Caries
Dental Caries in Children
Lead sponsor: University of Sao Paulo
Sponsor class: OTHER
First posted: 2020-07-30
Enrollment: 312
Sex: ALL
Minimum age (years): 3
Maximum age (years): 10
Standard ages: CHILD
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The objective of this randomized clinical study is to evaluate the survival of repairs in restorations using composite resin (CR) or high viscosity glass ionomer cement (GIC) in primary molars. This trial is nested to another study (NCT03520309), so patients will be enrolled from CARDEC 3. 312 restorations will be included and randomized into two groups: glass ionomer cement (Riva Self Cure, SDI, Australia) and composite resin (Filtek Bulk Fill and Filtek Bulk Fill Flow, 3M ESPE, USA). After the end of treatments, patients will be followed for 24 months to assess the success of the restorations, which will be considered as the absence of the need for reintervention. The Kaplan-Meier survival curves and the log-rank tests will be performed to assess survival between groups and Cox regression analysis will be used to compare the outcome with the variables (α = 5%).

Detailed description: Failed restorations in primary teeth will be repaired using GIC or composite resin.

Eligibility criteria: Inclusion Criteria:

* Children who have sought treatment in the School of Dentistry, University of Sao Paulo
* Children between 3 and 10 years old
* Children presenting at least one restoration (of any material, any surface and any integrity status) in primary teeth

Exclusion Criteria:

* Children whose parents did not agree to participate in the study
* Children with behavioural issues at the initial exam or who did not assent to participate in the study

Primary outcomes:
measure: Clinical success of restorations after repair
timeFrame: 24 months
Secondary outcomes:
measure: Cost- effectiveness of restorations repairs
timeFrame: 24 months
measure: Patient's discomfort
timeFrame: baseline
Other outcomes:
Locations:
city: São Paulo
country: Brazil
facility: University of São Paulo - School of Dentistry
Study officials:
affiliation: University of Sao Paulo
name: Daniela P Raggio
role: PRINCIPAL_INVESTIGATOR
References:
citation: Opdam NJ, van de Sande FH, Bronkhorst E, Cenci MS, Bottenberg P, Pallesen U, Gaengler P, Lindberg A, Huysmans MC, van Dijken JW. Longevity of posterior composite restorations: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):943-9. doi: 10.1177/0022034514544217. Epub 2014 Jul 21.
citation: Moncada G, Vildosola P, Fernandez E, Estay J, de Oliveira Junior OB, de Andrade MF, Martin J, Mjor IA, Gordan VV. Longitudinal results of a 10-year clinical trial of repair of amalgam restorations. Oper Dent. 2015 Jan-Feb;40(1):34-43. doi: 10.2341/14-045-C. Epub 2014 Aug 6.
citation: Gordan VV, Riley JL 3rd, Blaser PK, Mondragon E, Garvan CW, Mjor IA. Alternative treatments to replacement of defective amalgam restorations: results of a seven-year clinical study. J Am Dent Assoc. 2011 Jul;142(7):842-9. doi: 10.14219/jada.archive.2011.0274.
citation: Fernandez E, Martin J, Vildosola P, Oliveira Junior OB, Gordan V, Mjor I, Bersezio C, Estay J, de Andrade MF, Moncada G. Can repair increase the longevity of composite resins? Results of a 10-year clinical trial. J Dent. 2015 Feb;43(2):279-86. doi: 10.1016/j.jdent.2014.05.015. Epub 2014 Jun 4.
citation: Casagrande L, Laske M, Bronkhorst EM, Huysmans MCDNJM, Opdam NJM. Repair may increase survival of direct posterior restorations - A practice based study. J Dent. 2017 Sep;64:30-36. doi: 10.1016/j.jdent.2017.06.002. Epub 2017 Jun 8.
citation: Kanzow P, Wiegand A, Gostemeyer G, Schwendicke F. Understanding the management and teaching of dental restoration repair: Systematic review and meta-analysis of surveys. J Dent. 2018 Feb;69:1-21. doi: 10.1016/j.jdent.2017.09.010. Epub 2017 Sep 21.
citation: Qvist V, Poulsen A, Teglers PT, Mjor IA. The longevity of different restorations in primary teeth. Int J Paediatr Dent. 2010 Jan;20(1):1-7. doi: 10.1111/j.1365-263X.2009.01017.x.
citation: Dias AGA, Magno MB, Delbem ACB, Cunha RF, Maia LC, Pessan JP. Clinical performance of glass ionomer cement and composite resin in Class II restorations in primary teeth: A systematic review and meta-analysis. J Dent. 2018 Jun;73:1-13. doi: 10.1016/j.jdent.2018.04.004. Epub 2018 Apr 9.
citation: Tedesco TK, Calvo AF, Lenzi TL, Hesse D, Guglielmi CA, Camargo LB, Gimenez T, Braga MM, Raggio DP. ART is an alternative for restoring occlusoproximal cavities in primary teeth - evidence from an updated systematic review and meta-analysis. Int J Paediatr Dent. 2017 May;27(3):201-209. doi: 10.1111/ipd.12252. Epub 2016 Aug 4.
citation: Pitts NB, Richards D. Personalized treatment planning. Monogr Oral Sci. 2009;21:128-143. doi: 10.1159/000224217. Epub 2009 Jun 3.
citation: Hickel R, Peschke A, Tyas M, Mjor 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 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14.
citation: Ismail AI, Pitts NB, Tellez M; Authors of International Caries Classification and Management System (ICCMS); Banerjee A, Deery C, Douglas G, Eggertsson H, Ekstrand K, Ellwood R, Gomez J, Jablonski-Momeni A, Kolker J, Longbottom C, Manton D, Martignon S, McGrady M, Rechmann P, Ricketts D, Sohn W, Thompson V, Twetman S, Weyant R, Wolff M, Zandona A. The International Caries Classification and Management System (ICCMS) An Example of a Caries Management Pathway. BMC Oral Health. 2015;15 Suppl 1(Suppl 1):S9. doi: 10.1186/1472-6831-15-S1-S9. Epub 2015 Sep 15. No abstract available.
citation: Qvist V, Poulsen A, Teglers PT, Mjor IA. Fluorides leaching from restorative materials and the effect on adjacent teeth. Int Dent J. 2010 Jun;60(3):156-60.
citation: Gordan VV, Riley JL 3rd, Rindal DB, Qvist V, Fellows JL, Dilbone DA, Brotman SG, Gilbert GH; National Dental Practice-Based Research Network Collaborative Group. Repair or replacement of restorations: A prospective cohort study by dentists in The National Dental Practice-Based Research Network. J Am Dent Assoc. 2015 Dec;146(12):895-903. doi: 10.1016/j.adaj.2015.05.017.
citation: Hickel R, Brushaver K, Ilie N. Repair of restorations--criteria for decision making and clinical recommendations. Dent Mater. 2013 Jan;29(1):28-50. doi: 10.1016/j.dental.2012.07.006. Epub 2012 Aug 3.
citation: Frencken JE. Evolution of the the ART approach: highlights and achievements. J Appl Oral Sci. 2009;17 Suppl(spe):78-83. doi: 10.1590/s1678-77572009000700014.
citation: 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 Jun;7(2):85-91. doi: 10.1007/BF03320820.