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

Not Applicable

Completed

• Conditions: Dental Caries on Pit and Fissure Surface
• Interventions: Device: Isolite System; Other: Cotton Roll Technique

• Registration Number: NCT02668874
• Lead Sponsor: University of Iowa

Brief 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.

Study Timeline

• Study Start: 2015-02
• Study First Submitted: 2015-11-10
• Study First Submitted QC: 2016-01-26
• Study First Posted: 2016-01-29
• Primary Completion: 2017-08-21
• Study Completion: 2017-08-21
• Results First Submitted: 2019-05-14
• Status Verified: 2022-01
• Results First Submitted QC: 2022-01-01
• Last Update Submitted: 2022-01-01
• Results First Posted: 2022-02-01
• Last Update Posted: 2022-02-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 104

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Isolite System	Isolite System	The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant placement.
Cotton Roll technique	Cotton Roll Technique	A cotton roll is placed between the cheek and tongue prior to sealant placement.

Primary Outcome Measures

Name	Time	Method
Sealant Retention Percentage at 12 Months After Treatment	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.

Trial Locations

Locations (1)

University of Iowa College of Dentistry and Dental Clinics; 🇺🇸 Iowa City, Iowa, United States