Restoration Repairs Using Composite Resin Versus Glass Ionomer in Primary Molars: a Randomized Clinical Trial

NCT04491981 | Unknown

• 1 other identifier: REPAIRC3
• Study Type: interventional
• Target: 312
• Locations: 1 country
• Sites: 1

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%).

Conditions

Dental Caries; Dental Caries in Children

Outcome Measures

Primary Outcomes (1)

• Clinical success of restorations after repair

  Visual assessment using Frencken criteria for occlusal restoration and Roeleveld et al. criteria for occlusoproximal restorations

  24 months

Secondary Outcomes (2)

• Cost- effectiveness of restorations repairs

  24 months

• Patient's discomfort

  baseline

Study Arms (2)

Encapsulated Glass Ionomer Cement

EXPERIMENTAL

Repair of restorations in primary molars using a high viscosity glass ionomer cement (RIVA Self Cure - SDI)

Procedure: Encapsulated Glass Ionomer Cement

Composite resin

EXPERIMENTAL

Repair of restorations in primary molars using a composite resin (Filtek Bulk Fill- 3M ESPE)

Procedure: Composite resin

Interventions

Encapsulated Glass Ionomer Cement PROCEDURE

Repair of restorations in primary molars using Encapsulated High Viscosity Glass Ionomer (RIVA Self Cure - SDI). No local anesthesia will be used. A portion of the former restoration and infected carious tissue can be removed if necessary, and then the restoration will be repaired with GIC (Glass Ionomer Cement).

Encapsulated Glass Ionomer Cement

Composite resin PROCEDURE

Repair of restorations in primary molars using composite resin (Filtek Bulk Fill- 3M ESPE.) No local anesthesia will be used.A portion of the former restoration and infected carious tissue can be removed if necessary, and then the restoration will be repaired with CR (composite resin).

Composite resin

Eligibility Criteria

• Age: 3 Years - 10 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Sao Paulo: lead

Study Sites (1)

University of São Paulo - School of Dentistry

São Paulo, 05508-000, Brazil

Location

Related Publications (17)

• 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.

  PMID: 25048250 BACKGROUND

• 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.

  PMID: 25100406 BACKGROUND

• 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.

  PMID: 21719808 BACKGROUND

• 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.

  PMID: 24907560 BACKGROUND

• 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.

  PMID: 28602850 BACKGROUND

• 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.

  PMID: 28943362 BACKGROUND

• 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.

  PMID: 20059587 BACKGROUND

• 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.

  PMID: 29649506 BACKGROUND

• 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.

  PMID: 27489205 BACKGROUND

• Pitts NB, Richards D. Personalized treatment planning. Monogr Oral Sci. 2009;21:128-143. doi: 10.1159/000224217. Epub 2009 Jun 3.

  PMID: 19494680 BACKGROUND

• 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.

  PMID: 20628774 BACKGROUND

• 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.

  PMID: 26391116 BACKGROUND

• 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.

  PMID: 20684440 BACKGROUND

• 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.

  PMID: 26610834 BACKGROUND

• 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.

  PMID: 22867859 BACKGROUND

• 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.

  PMID: 21499660 BACKGROUND

• 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.

  PMID: 17140533 BACKGROUND

Related Links

• Randomization website

MeSH Terms

Conditions

Dental Caries

Interventions

Composite Resins

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Resins, Synthetic; Plastics; Polymers; Macromolecular Substances; Dental Materials; Biomedical and Dental Materials; Manufactured Materials; Technology, Industry, and Agriculture

Study Officials

• Daniela P Raggio

  University of Sao Paulo

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Daniela P Raggio

CONTACT

+5511976922202; danielar@usp.br

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor Doctor

Study Record Dates

• First Submitted: June 15, 2020
• First Posted: July 30, 2020
• Study Start: July 1, 2021
• Primary Completion: August 1, 2022
• Study Completion: August 1, 2023
• Last Updated: April 13, 2021

Record last verified: 2021-04

Locations

BR (1)