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

Dental Caries Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01924611
• Other study ID #: CEP 134/04
• Status: Completed
• Phase: N/A
• First received: August 13, 2013
• Last updated: August 15, 2013
• Start date: September 2004
• Est. completion date: March 2007

Study information

• Verified date: August 2013
• Source: Federal University of Paraíba
• Contact: n/a
• Is FDA regulated: No
• Health authority: Brazil: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 232
• Est. completion date: March 2007
• Est. primary completion date: March 2007
• Gender: Both
• Age group: 6 Years to 7 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Dental Caries

Intervention

Procedure:
• Atraumatic Restorative Technique using cotton rolls
Atraumatic Restorative Technique using cotton rolls.
• 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.

Locations

Country	Name	City	State
Brazil	Universidade Federal da Paraíba	João Pessoa	Paraíba

Sponsors (2)

Lead Sponsor	Collaborator
Federal University of Paraíba	Academic Centre for Dentistry in Amsterdam

Country where clinical trial is conducted

Brazil, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of teeth with fractured restorations.	The teeth were assessed every 6 months for a period of 2 years and they were graded according to restoration fractures.	2 years	No