Two Years Survival Rate of Class II ART Restorations in Primary Molars Using Either Rubber Dam or Cotton Rolls.
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- Enrollment
- 232
- Locations
- 2
- Primary Endpoint
- Number of teeth with fractured restorations.
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 6 Years to 7 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- No
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,
Outcomes
Primary Outcomes
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.
Secondary Outcomes
No secondary outcomes reported
Investigators
Thiago Saads Carvalho
Principal Investigator
Federal University of Paraíba