Two Years Survival Rate of Class II ART Restorations in Primary Molars Using Two Ways to Avoid Saliva Contamination

August 15, 2013 updated by: Thiago Saads Carvalho, Federal University of Paraíba

Two Years Survival Rate of Class II ART Restorations in Primary Molars Using Either Rubber Dam or Cotton Rolls.

AIM: To evaluate influence of two methods to avoid saliva contamination on the survival rate of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both genders, were selected having one primary molar with a proximal dentine lesion. The children were randomly divided into two groups: a control group with class II ART restoration made using cotton rolls and an experimental group using rubber dam. The restorations were made and they were followed up every six months. After two years, the results were compilated and analyzed.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

To evaluate influence of two methods to avoid saliva contamination on the survival rate of atraumatic restorations in primary molars. 232 children, aged between 6-7 years, of both genders, were selected having one primary molar with a proximal dentine lesion. The children were randomly divided into two groups: a control group with class II ART restoration made using cotton rolls and an experimental group using rubber dam. The restorations were made and they were followed up every six months. After two years, the results were compilated and analyzed.

Study Type

Interventional

Enrollment (Actual)

232

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
    • Paraíba
      • João Pessoa, Paraíba, Brazil, 58000-000
        • Universidade Federal da Paraíba

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

6 years to 7 years (Child)

Accepts Healthy Volunteers

N/A

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Children of both genders enrolled in school,
  • Children aged between 6 and 7 years,
  • having cavity with access to ART hand instruments,
  • cavity with a mesio-distal maximum dimension of 1mm and a buccal-lingual maximum dimension of 2mm length, measured on the oclusal surface,
  • proximal surface of the adjacent tooth should be unimpaired, without visible lesions,

Exclusion Criteria:

  • Cavity lesions having pulpal involvement, swelling, fistula or pain were not included in the study,
  • Children out of the age range,

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 Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Control Group
Atraumatic Restorative Technique using cotton rolls.
Procedure: Atraumatic Restorative Technique using cotton rolls
Atraumatic Restorative Technique using cotton rolls.
Other Names:
  • Atraumatic Restorative Technique
Experimental: Experimental Group
Atraumatic Restorative Technique using rubber dam.
Procedure: Atraumatic Restorative Technique

Atraumatic Restorative Technique is typically used in Minimally invasive Dentistry.

This restoration technique is made using only hand instruments and is possible to be carried out in children in schools.

This particular time, the isolation of the surgical/tooth area was made using rubber dam as saliva barrier.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Number of teeth with fractured restorations.
Time Frame: 2 years
The teeth were assessed every 6 months for a period of 2 years and they were graded according to restoration fractures.
2 years

Collaborators and Investigators

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

Sponsor

Federal University of Paraíba

Collaborators

Academic Centre for Dentistry in Amsterdam

Investigators

  • Study Director: Evert van Amerongen, DDS, PhD, Professor, Academic Centre for Dentistry in Amsterdam
  • Study Director: Fabio Correia Sampaio, DDS PhD PostDoc, UFPB

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

September 1, 2004

Primary Completion (Actual)

March 1, 2007

Study Completion (Actual)

March 1, 2007

Study Registration Dates

First Submitted

August 13, 2013

First Submitted That Met QC Criteria

August 15, 2013

First Posted (Estimate)

August 16, 2013

Study Record Updates

Last Update Posted (Estimate)

August 16, 2013

Last Update Submitted That Met QC Criteria

August 15, 2013

Last Verified

August 1, 2013

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CEP 134/04

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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