Success rate of restorations repaired using glass ionomer cement and composite resin: A randomized clinical trial

• Grant number: 22/04054-7
• Support Opportunities: Scholarships in Brazil - Doctorate
• Effective date (Start): April 01, 2023
• Effective date (End): July 31, 2026
• Field of knowledge: Health Sciences - Dentistry - Pediatric Dentistry
• Principal Investigator: Daniela Prócida Raggio
• Grantee: Jonathan Rafael Garbim
• Host Institution: Faculdade de Odontologia (FO). Universidade de São Paulo (USP). São Paulo , SP, Brazil

Abstract

Restorative failures are usually caused by fractures of the adjacent material or "secondary" caries lesions. The repair of restorations has been an alternative to complete material replacement in the context of Minimum Intervention Dentistry (MID), preserving tooth tissue and reducing the risk of pulp complications. The aim of this randomized clinical trial will be to evaluate the success of repairs with encapsulated glass ionomer cement (IAC) or bulk-fill composite resin (BC) in deciduous molars. Children aged 3 to 10 years with at least one restoration in requirement of repair in deciduous molars will be selected from the CARDEC-3 research project at the University of São Paulo. Three hundred and twelve teeth (312) will be randomly allocated into two groups (n=156): (1) GIC (Riva Self Cure, SDI, AUS) or CR (Filtek Bulk Fill and Filtek Bulk Fill Flow, 3M ESPE, USA). Randomization will be stratified considering the size of repair needed (up to 1 mm or greater than 1 mm). Flowable CR may be placed in restoration with a defect size up to 1 mm, while conventional CR in restoration with a defect size greater than 1 mm. Treatments will be performed in the dental clinic of the University of São Paulo School of Dentistry (FOUSP) by trained operators. The primary outcome will be the success of the repaired restorations, assessed after 6, 12, 18 and 24 months by a blinded, trained and calibrated examiner. The repair will be considered successful if there is no need for reintervention. Restoration survival will be evaluated by Kaplan-Meier survival analysis. The influence of the restorative treatment on the primary outcome will be verified by Cox regression with shared fragility, as well as the influence of the explained variables on the success rate (±=5%). Clinicaltrials.gov Registry: NCT03520309