Back to resultsA Clinical Trial Comparing Isolite® vs. Cotton Roll Isolation in the Placement of Dental Sealants
Primary Purpose
Dental Caries on Pit and Fissure Surface
Status
Completed
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Isolite System
Cotton Roll Technique
Sponsored by
About this trial
This is an interventional treatment trial for Dental Caries on Pit and Fissure Surface focused on measuring Pit and Fissure sealants, Isolation, permanent teeth, children, Isolite®, Dental caries
Eligibility Criteria
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
Sites / Locations
- University of Iowa College of Dentistry and Dental Clinics
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
Isolite System
Cotton Roll technique
Arm Description
The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant placement.
A cotton roll is placed between the cheek and tongue prior to sealant placement.
Outcomes
Primary Outcome Measures
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.
Secondary Outcome Measures
Full Information
NCT ID
NCT02668874
First Posted
November 10, 2015
Last Updated
January 1, 2022
Sponsor
University of Iowa
Collaborators
Delta Dental of Iowa
1. Study Identification
Unique Protocol Identification Number
NCT02668874
Brief Title
A Clinical Trial Comparing Isolite® vs. Cotton Roll Isolation in the Placement of Dental Sealants
Official Title
A Clinical Trial Comparing Isolite® vs Cotton Roll Isolation in the Placement of Dental Sealants
Study Type
Interventional
2. Study Status
Record Verification Date
January 2022
Overall Recruitment Status
Completed
Study Start Date
February 2015 (undefined)
Primary Completion Date
August 21, 2017 (Actual)
Study Completion Date
August 21, 2017 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Iowa
Collaborators
Delta Dental of Iowa
4. Oversight
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
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries on Pit and Fissure Surface
Keywords
Pit and Fissure sealants, Isolation, permanent teeth, children, Isolite®, Dental caries
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
ParticipantInvestigatorOutcomes Assessor
Masking Description
Triple:
Participants, Investigator, and Outcome assessors do not know the randomization. However, it was hard to blind the care provider.
Allocation
Randomized
Enrollment
104 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Isolite System
Arm Type
Other
Arm Description
The Isolite technique utilizes a flexible plastic dental adapter to separate the cheek and tongue prior to sealant placement.
Arm Title
Cotton Roll technique
Arm Type
Other
Arm Description
A cotton roll is placed between the cheek and tongue prior to sealant placement.
Intervention Type
Device
Intervention Name(s)
Isolite System
Intervention Type
Other
Intervention Name(s)
Cotton Roll Technique
Primary Outcome Measure Information:
Title
Sealant Retention Percentage at 12 Months After Treatment
Description
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.
Time Frame
12 months after treatment
10. Eligibility
Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Shin
Organizational Affiliation
Director of Clinical Research
Official's Role
Study Director
Facility Information:
Facility Name
University of Iowa College of Dentistry and Dental Clinics
City
Iowa City
State/Province
Iowa
ZIP/Postal Code
52242
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
A Clinical Trial Comparing Isolite® vs. Cotton Roll Isolation in the Placement of Dental Sealants
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