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

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.

Study Overview

• Status: Completed
• Conditions: Dental Caries on Pit and Fissure Surface
• Intervention / Treatment: Device: Isolite System; Other: Cotton Roll Technique

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 Type: Interventional
• Enrollment (Actual): 104
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Iowa
    • Iowa City, Iowa, United States, 52242
      • University of Iowa College of Dentistry and Dental Clinics

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 2 years to 12 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Triple

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Other: Isolite System; The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant placement.	Device: Isolite System
Other: Cotton Roll technique; A cotton roll is placed between the cheek and tongue prior to sealant placement.	Other: Cotton Roll Technique

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: University of Iowa
• Collaborators: Delta Dental of Iowa
• Investigators: Study Director: Shin, Director of Clinical Research

Study record dates

Study Major Dates

• Study Start: February 1, 2015
• Primary Completion (Actual): August 21, 2017
• Study Completion (Actual): August 21, 2017

Study Registration Dates

• First Submitted: November 10, 2015
• First Submitted That Met QC Criteria: January 26, 2016
• First Posted (Estimate): January 29, 2016

Study Record Updates

• Last Update Posted (Actual): February 1, 2022
• Last Update Submitted That Met QC Criteria: January 1, 2022
• Last Verified: January 1, 2022

More Information

Terms related to this study

• Keywords: children; Dental caries; Isolation; Pit and Fissure sealants; permanent teeth; Isolite®
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries
• Other Study ID Numbers: 201502801

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: Yes