A Clinical Trial Comparing Isolite® vs. Cotton Roll Isolation in the Placement of Dental Sealants

Study Overview
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Brief Summary
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The purpose of this split-mouth, randomized, controlled trial is to evaluate the retention rates of sealants placed under Isolite vs. cotton roll isolation. This study will also compare the patient and operator acceptability and satisfaction of the two isolation techniques as well as the time consumed for sealant application during the two isolation techniques.

Detailed Description
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104 regular patients at the College of Dentistry Department of Pediatric Dentistry Clinics, ages 6-16 years, will be invited to participate in this study. Matched contralateral pairs of first and second molars and premolars will be randomized to receive sealants with the use of the device (Isolite) for isolation or with the use of cotton roll isolation. All sealants will be placed by pediatric dentistry residents. Sealants will be placed on first and second permanent molars that have a matched contralateral molar requiring a sealant as well. Photographs may be taken of the sealants on the day of placement and at a 6-month and 12 month recalls. Retention of the sealants will be evaluated and scored by calibrated pediatric dentists.

Official Title
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A Clinical Trial Comparing Isolite® vs Cotton Roll Isolation in the Placement of Dental Sealants

Conditions
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Dental Caries on Pit and Fissure Surface

Intervention / Treatment
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* Device: Isolite System
* Other: Cotton Roll Technique


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy patients: American Society of Anesthesiologists (ASA) I or II Good cooperation: Frank1 3 or 4 Aged between 6-16 years old at the day of sealant placement Minimum of two, maximum of sixteen, matched contralateral permanent molars or premolars. Exclusion Criteria: Teeth with a history of past or current caries Teeth with a linical presentation of fluorosis, hypoplasia or any developmental anomalies Teeth with clinical or radiographic evidence of pathology Teeth with a history of restoration or sealant Patients who are poorly behaved

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

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
Interventional Model Description: Simple randomization will be used for assignment of the treatment groups. Randomization: Two application methods will be used in each subject in order to place sealants, one using the Isolite system and one using the cotton roll system.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Other: Isolite System<br>The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant placement. | Device: Isolite System<br> <br> |
| Other: Cotton Roll technique<br>A cotton roll is placed between the cheek and tongue prior to sealant placement. | Other: Cotton Roll Technique<br> <br> |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Sealant Retention Percentage at 12 Months After Treatment | Physical examination will be done in order to determine if there is a percentage difference in retention rate of teeth, specifically 12 months after treatment. | 12 months after treatment | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Pit and Fissure sealants, Isolation, permanent teeth, children, Isolite®, Dental caries