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

Not Applicable

Completed

• Conditions: Dental Caries
• Interventions: Procedure: Atraumatic Restorative Technique using cotton rolls; Procedure: Atraumatic Restorative Technique

• Registration Number: NCT01924611
• Lead Sponsor: Federal University of Paraíba

Brief Summary

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

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 Timeline

• Study Start: 2004-09
• Primary Completion: 2007-03
• Study Completion: 2007-03
• Status Verified: 2013-08
• Study First Submitted: 2013-08-13
• Study First Submitted QC: 2013-08-15
• Last Update Submitted: 2013-08-15
• Study First Posted: 2013-08-16
• Last Update Posted: 2013-08-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 232

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Group	Atraumatic Restorative Technique using cotton rolls	Atraumatic Restorative Technique using cotton rolls.
Experimental Group	Atraumatic Restorative Technique	Atraumatic Restorative Technique using rubber dam.

Primary Outcome Measures

Name	Time	Method
Number of teeth with fractured restorations.	2 years	The teeth were assessed every 6 months for a period of 2 years and they were graded according to restoration fractures.

Trial Locations

Locations (1)

Universidade Federal da Paraíba; 🇧🇷 João Pessoa, Paraíba, Brazil