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

NCT02668874 | Completed Results FDA Device

• 1 other identifier: 201502801
• Study Type: interventional
• Target: 104
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries on Pit and Fissure Surface

Keywords

Pit and Fissure sealants; Isolation; permanent teeth; children; Isolite®; Dental caries

Outcome Measures

Primary Outcomes (1)

• 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

Study Arms (2)

Isolite System

OTHER

The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant placement.

Device: Isolite System

Cotton Roll technique

OTHER

A cotton roll is placed between the cheek and tongue prior to sealant placement.

Other: Cotton Roll Technique

Interventions

Isolite System DEVICE

Isolite System

Cotton Roll Technique OTHER

Cotton Roll technique

Eligibility Criteria

• Age: 6 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Iowa: lead
• Delta Dental of Iowa: collaborator

Study Sites (1)

University of Iowa College of Dentistry and Dental Clinics

Iowa City, Iowa, 52242, United States

Location

MeSH Terms

Conditions

Van der Woude syndrome; Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Results Point of Contact

• Title: Director of Clinical Research
• Organization: University of Iowa College of Dentistry

dentistry-research@uiowa.edu

319-467-1398

Study Officials

• Shin

  Director of Clinical Research

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: Triple: Participants, Investigator, and Outcome assessors do not know the randomization. However, it was hard to blind the care provider.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Simple randomization will be used for assignment of the treatment groups. Randomization: Two application methods will be used in each subject in order to place sealants, one using the Isolite system and one using the cotton roll system.

Study Record Dates

• First Submitted: November 10, 2015
• First Posted: January 29, 2016
• Study Start: February 1, 2015
• Primary Completion: August 21, 2017
• Study Completion: August 21, 2017
• Last Updated: February 1, 2022
• Results First Posted: February 1, 2022

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)