CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 530 enrolled
Drug / intervention
GIC Restorations +2 moreprocedure
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02217098
NCT02217098N/ACompleted

The Survival Rate of Glass Ionomer Cement, Glass Carbomer Cement and Compomer in Occlusal and Proximal ART Restorations

Daniela Prócida Raggio·interventional·Posted Aug 15, 2014·Updated Nov 21, 2018

In Brief

A clinical study evaluating GIC Restorations, Carbomer Restorations, and 1 other intervention for Caries Involving Multiple Surfaces of Tooth and 2 related conditions. Completed, enrolled 530 participants across 1 site.

Detailed Summary

The null hypothesis of this study is that GCC, GIC and compomer have the same survival rate when used for the treatment of occlusal and proximal caries in primary molars with ART under field conditions. This research will be done under field conditions in Barueri, a city in the state of São Paulo, Brazil. A total of 600 patients will be selected. After 1, 6, 12, 18 and 24 months the restorations and teeth will be evaluated by two independent evaluators. Only children whose parent or representative who have signed an informed consent are included in this research.The ART treatments will be done by two dental students. The operators will receive the same ART-training. The children will be randomly assigned to one of the operators. The restorative material to be used in each child will be assigned by another random list. It will be performed descriptive analyses to describe the sample. Bivariate analyses will be performed to test the hypothesis. The data will be analyzed with a chi-square test to compare the survival rates of GIC and GCC. Some co-variables will be evaluated, such as: operator effect, the influence of the cavity size on the survival rate, the position of the tooth, the dentists preferred side, the child's dmft/DMFT, contamination and finally the preoperative conditions. The effect of these variables on the survival rate will be evaluated using a regression analysis.

Study Details

Timeline

N/ACompletedFinished
201520162017201820192020202120222023202420252026
First PostedAug 15, 2014
Enrollment StartJul 1, 2014
Primary CompletionFeb 1, 2015
Study CompletionSep 10, 2018
TodayJul 2, 2026
Enrollment to primary: 7 monthsPosted 11.9 years ago

Interventions

GIC Restorationsprocedure

Restorations using Glass Ionomer Cement

Carbomer Restorationsprocedure

Restorations using Glass Carbomer

Compomer Restorationsprocedure

Restorations using Compomer