NCT02668874

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 104 (actual)
• Sponsor: University of Iowa · Academic / Other
• Sex: All
• Age: 6 Years – 16 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Dental Caries on Pit and Fissure Surface

Interventions

Type	Name	Description
DEVICE	Isolite System
OTHER	Cotton Roll Technique

Timeline

• Start date: 2015-02-01
• Primary completion: 2017-08-21
• Completion: 2017-08-21
• First posted: 2016-01-29
• Last updated: 2022-02-01
• Results posted: 2022-02-01

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study