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

Study Results

Results available

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

104 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-28

Study Completion Date

2017-08-21

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.

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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.

Conditions

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Dental Caries on Pit and Fissure Surface

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors

Triple:

Participants, Investigator, and Outcome assessors do not know the randomization. However, it was hard to blind the care provider.

Study Groups

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Isolite System

The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant placement.

Group Type OTHER

Isolite System

Intervention Type DEVICE

Cotton Roll technique

A cotton roll is placed between the cheek and tongue prior to sealant placement.

Group Type OTHER

Cotton Roll Technique

Intervention Type OTHER

Interventions

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Isolite System

Intervention Type DEVICE

Cotton Roll Technique

Intervention Type OTHER

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

Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes