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

Study Overview
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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.

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

Conditions
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Dental Caries

Intervention / Treatment
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* Procedure: Atraumatic Restorative Technique using cotton rolls
* Procedure: Atraumatic Restorative Technique


Participation Criteria
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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,

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 7 Years

Sexes Eligible for Study
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All

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Control Group<br>Atraumatic Restorative Technique using cotton rolls. | Procedure: Atraumatic Restorative Technique using cotton rolls<br>* Atraumatic Restorative Technique using cotton rolls.<br>* Other names: Atraumatic Restorative Technique;|
| Experimental: Experimental Group<br>Atraumatic Restorative Technique using rubber dam. | Procedure: Atraumatic Restorative Technique<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental caries, Atraumatic Restorative Technique