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

NCT02217098 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 530

Last updated 2018-11-21

No results posted yet for this study

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.

Conditions

  • Caries Involving Multiple Surfaces of Tooth
  • Dental Caries on Chewing Surface of Tooth
  • Dental Caries Extending Into Dentine

Interventions

PROCEDURE

GIC Restorations

Restorations using Glass Ionomer Cement

PROCEDURE

Carbomer Restorations

Restorations using Glass Carbomer

PROCEDURE

Compomer Restorations

Restorations using Compomer

Sponsors & Collaborators

  • Academic Centre for Dentistry in Amsterdam

    collaborator OTHER

  • Daniela Prócida Raggio

    lead OTHER

Principal Investigators

  • Daniela P Raggio, Professor · Universidade de Sao Paulo - Faculdade de Odontologia

  • Isabel O Costa, PhD · University of Sao Paulo

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
4 Years
Max Age
8 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2014-07-31
Primary Completion
2015-02-28
Completion
2018-09-10

Countries

  • Brazil

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02217098 on ClinicalTrials.gov