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

Sponsor

Federal University of Paraíba (Other)

Overall Status

Completed

CT.gov ID

NCT01924611

Collaborator

Academic Centre for Dentistry in Amsterdam (Other)

232

Enrollment

Location

Arms

29.9

Duration (Months)

7.8

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Dental Caries	Procedure: Atraumatic Restorative Technique using cotton rolls Procedure: Atraumatic Restorative Technique	N/A

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 Design

Study Type:

Interventional

Actual Enrollment :

232 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Outcomes Assessor)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2004

Actual Primary Completion Date :

Mar 1, 2007

Actual Study Completion Date :

Mar 1, 2007

Arms and Interventions

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.

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.

Outcome Measures

Primary Outcome Measures

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.

Eligibility Criteria

Criteria

Ages Eligible for Study:

6 Years to 7 Years

Sexes Eligible for Study:

All

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,

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Universidade Federal da Paraíba	João Pessoa	Paraíba	Brazil	58000-000

Sponsors and Collaborators

Federal University of Paraíba
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 Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Thiago Saads Carvalho, Principal Investigator, Federal University of Paraíba

ClinicalTrials.gov Identifier:

NCT01924611

Other Study ID Numbers:

CEP 134/04

First Posted:

Aug 16, 2013

Last Update Posted:

Aug 16, 2013

Last Verified:

Aug 1, 2013

Keywords provided by Thiago Saads Carvalho, Principal Investigator, Federal University of Paraíba

Dental caries

Atraumatic Restorative Technique

Additional relevant MeSH terms:

Dental Caries

Study Results

No Results Posted as of Aug 16, 2013