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



Status:Completed
Conditions:Dental
Therapuetic Areas:Dental / Maxillofacial Surgery
Healthy:No
Age Range:6 - 16
Updated:1/2/2019
Start Date:February 2015
End Date:August 21, 2017

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

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.

100 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 deice (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.

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
We found this trial at
1
site
Iowa City, Iowa 52242
Principal Investigator: Arwa I Owais, BDS, MS
Phone: 319-335-7377
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mi
from
Iowa City, IA
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