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

NCT ID: NCT01924611

Last Updated: 2013-08-16

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

232 participants

Study Classification

INTERVENTIONAL

Study Start Date

2004-09-30

Study Completion Date

2007-03-31

Brief Summary

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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.

Detailed Description

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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.

Conditions

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Dental Caries

Keywords

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Dental caries Atraumatic Restorative Technique

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Study Groups

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Control Group

Atraumatic Restorative Technique using cotton rolls.

Group Type ACTIVE_COMPARATOR

Atraumatic Restorative Technique using cotton rolls

Intervention Type PROCEDURE

Atraumatic Restorative Technique using cotton rolls.

Experimental Group

Atraumatic Restorative Technique using rubber dam.

Group Type EXPERIMENTAL

Atraumatic Restorative Technique

Intervention Type PROCEDURE

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.

Interventions

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Atraumatic Restorative Technique using cotton rolls

Atraumatic Restorative Technique using cotton rolls.

Intervention Type 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.

Intervention Type PROCEDURE

Other Intervention Names

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Atraumatic Restorative Technique

Eligibility Criteria

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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,
Minimum Eligible Age

6 Years

Maximum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Academic Centre for Dentistry in Amsterdam

OTHER

Sponsor Role collaborator

Federal University of Paraíba

OTHER

Sponsor Role lead

Responsible Party

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Thiago Saads Carvalho

Principal Investigator

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Evert van Amerongen, DDS, PhD, Professor

Role: STUDY_DIRECTOR

Academic Centre for Dentistry in Amsterdam

Fabio Correia Sampaio, DDS PhD PostDoc

Role: STUDY_DIRECTOR

UFPB

Locations

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Universidade Federal da Paraíba

João Pessoa, Paraíba, Brazil

Site Status

Countries

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Brazil

Other Identifiers

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CEP 134/04

Identifier Type: -

Identifier Source: org_study_id