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

Dental Caries on Pit and Fissure Surface Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02668874
• Other study ID #: 201502801
• Status: Completed
• Phase: N/A
• Start date: February 2015
• Est. completion date: August 21, 2017

Study information

• Verified date: January 2022
• Source: University of Iowa
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 104
• Est. completion date: August 21, 2017
• Est. primary completion date: August 21, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 16 Years

Eligibility

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

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries on Pit and Fissure Surface

Intervention

Device:
• Isolite System

Other:
• Cotton Roll Technique

Locations

Country	Name	City	State
United States	University of Iowa College of Dentistry and Dental Clinics	Iowa City	Iowa

Sponsors (2)

Lead Sponsor	Collaborator
University of Iowa	Delta Dental of Iowa

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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