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

November 19, 2018 updated by: Daniela Prócida Raggio

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 Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

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, 300 patients with one occlusal carie lesion and 300 different patients with occlusal proximal cavities. 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. Only one restoration per child will be included in this study. If more carious lesions are present, one of them will be randomly selected for this research. The remaining carious lesions will be also be treated. 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.

The selected children can have or an occlusal (O) cavity or an occlusalproximal (OP) cavity. So, the stratum of the study is OP and O. So, one randomization list will be performed for occlusal cavities and another randomization list will be used for occlusal proximal cavities.

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 Type

Interventional

Enrollment (Actual)

530

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Brazil
      • Sao Paulo, Brazil, 05508-000
        • School of Dentistry - Sao Paulo University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

4 years to 8 years (CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

Inclusion criteria for the patient:

  • Healthy children, age: 4-8 years
  • At least one occlusal or proximal carious lesion in primary molar involving dentin
  • Cooperative behavior
  • Presence of antagonist of the tooth

Inclusion criteria for the tooth:

  • Carious lesion involving dentin with dimensions bucco-lingual and mesio-distal not greater than 2.5mm, occluso-cervical not greater than 2.0mm
  • Absence of tooth mobility and abscess or fistula near to the selected tooth

Exclusion Criteria:

  • Only children whose parent or representative who have signed an informed consent are included in this research. Only one restoration per child will be included in this study. If more carious lesions are present, one of them will be randomly selected for this research.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: GIC Restorations
Restorations using Glass Ionomer Cement
Procedure: GIC Restorations
Restorations using Glass Ionomer Cement
Experimental: Compomer Restorations
Restorations using Compomer
Procedure: Compomer Restorations
Restorations using Compomer
Experimental: Carbomer Restorations
Restorations using Glass Carbomer
Procedure: Carbomer Restorations
Restorations using Glass Carbomer

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Survival rate (longevity) of ART restorations using differents materials
Time Frame: 6, 12, 24 and 36 months follow-up
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 occlusoproximal caries in primary molars with ART under field conditions.
6, 12, 24 and 36 months follow-up

Secondary Outcome Measures

Outcome Measure
Time Frame
Association between survival and gender
Time Frame: 6, 12, 24 and 36 months follow-up
6, 12, 24 and 36 months follow-up
Association between survival and DMFT (caries experience)
Time Frame: 6, 12, 24 and 36 months follow-up
6, 12, 24 and 36 months follow-up
Association between survival and occlusal contact after restoration
Time Frame: 6, 12, 24 and 36 months follow-up
6, 12, 24 and 36 months follow-up
Association between sucess and ICDAS of the adjacent tooth (if there is a dentin cavited lesion or not)
Time Frame: 6, 12, 24 and 36 months follow-up
6, 12, 24 and 36 months follow-up
Cost-effectiveness of the 3 materials and their association with survival rate
Time Frame: 6, 12, 24 and 36 months follow-up
6, 12, 24 and 36 months follow-up
Comparition between Success of the restoration and longevity of the teeth (with or without pulp damage and exfoliation in the normal time)
Time Frame: 6, 12, 24 and 36 months follow-up
6, 12, 24 and 36 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Daniela Prócida Raggio

Collaborators

Academic Centre for Dentistry in Amsterdam

Investigators

  • Principal Investigator: Daniela P Raggio, Professor, Universidade de Sao Paulo - Faculdade de Odontologia
  • Study Director: Isabel O Costa, PhD, University of Sao Paulo

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

July 1, 2014

Primary Completion (Actual)

February 1, 2015

Study Completion (Actual)

September 10, 2018

Study Registration Dates

First Submitted

May 21, 2014

First Submitted That Met QC Criteria

August 12, 2014

First Posted (Estimate)

August 15, 2014

Study Record Updates

Last Update Posted (Actual)

November 21, 2018

Last Update Submitted That Met QC Criteria

November 19, 2018

Last Verified

November 1, 2018

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • FOUSP6808912

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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