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

N/AUnknownNCT04491981

University of Sao Paulo312 enrolled

Overview

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%).

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

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

312

Conditions

Dental Caries Dental Caries in Children

Encapsulated Glass Ionomer CementPROCEDURE

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 resinPROCEDURE

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).

Eligibility

Sex: ALLMin age: 3 YearsMax age: 10 Years

Medical Language ↔ Plain English

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

Outcomes

Primary Outcomes

Clinical success of restorations after repair

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

Time frame: 24 months

Secondary Outcomes

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)

Time frame: 24 months

Patient's discomfort

Wong-Baker facial scale - from 0 to 5 (immediately after treatment)

Time frame: baseline