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

Dental Caries Clinical Trial

Official title:

Longevity of Restoration Repairs Using Composite Resin Versus High Viscosity Glass Ionomer in Primary Molars: Randomized Clinical Trial

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04491981
• Other study ID #: REPAIRC3
• Status: Not yet recruiting
• Phase: N/A
• Start date: July 1, 2021
• Est. completion date: August 1, 2023

Study information

• Verified date: April 2021
• Source: University of Sao Paulo
• Contact: Daniela P Raggio
• Phone: +5511976922202
• Email: danielar[@]usp.br
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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%).

Description:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 312
• Est. completion date: August 1, 2023
• Est. primary completion date: August 1, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 3 Years to 10 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children

Intervention

Procedure:
• Encapsulated Glass Ionomer Cement
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).
• Composite resin
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).

Locations

Country	Name	City	State
Brazil	University of São Paulo - School of Dentistry	São Paulo

Sponsors (1)

Lead Sponsor	Collaborator
University of Sao Paulo

Country where clinical trial is conducted

Brazil, 

References & Publications (17)

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. — View 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. — View Citation

Fernández E, Martín J, Vildósola 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. — View Citation

Frencken JE. Evolution of the the ART approach: highlights and achievements. J Appl Oral Sci. 2009;17 Suppl:78-83. — View Citation

Gordan VV, Riley JL 3rd, Blaser PK, Mondragon E, Garvan CW, Mjör 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. — View 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. — View Citation

Hickel R, Brüshaver 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. Review. — View Citation

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 Aug;14(4):349-66. doi: 10.1007/s00784-010-0432-8. Epub 2010 Jul 14. — View 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:S9. doi: 10.1186/1472-6831-15-S1-S9. Epub 2015 Sep 15. — View Citation

Kanzow P, Wiegand A, Göstemeyer 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. — View Citation

Moncada G, Vildósola P, Fernández E, Estay J, de Oliveira Júnior OB, de Andrade MF, Martin J, Mjör 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. — View 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. Review. — View Citation

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

Qvist V, Poulsen A, Teglers PT, Mjör IA. Fluorides leaching from restorative materials and the effect on adjacent teeth. Int Dent J. 2010 Jun;60(3):156-60. — View Citation

Qvist V, Poulsen A, Teglers PT, Mjör 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. — View 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. — View 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. Review. — View Citation

* Note: There are 17 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Cost- effectiveness of restorations repairs	To assess this outcome measure we will consider the percentage of patients needing new operatory interventions and costs will be assessed in monetary units (US dollars)	24 months
Secondary	Patient's discomfort	Wong-Baker facial scale - from 0 to 5 (immediately after treatment)	baseline

External Links

•   Randomization website