- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03886727
Effectiveness of Rubber Dam Isolation Versus Cotton Roll Isolation on Bonded Fissure Sealant Retention
November 4, 2019 updated by: Zafer Cavit Cehreli, DDS, PhD
Clinical Retention of Bonded Resin Sealants Placed With Rubber Dam Versus Cotton Roll Isolation
The purpose of this study is to evaluate and compare the clinical retention of bonded fissure sealants placed under rubber dam isolation and cotton roll isolation.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
50
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Louisiana
-
New Orleans, Louisiana, United States, 70119
- LSU School of Dentistry, Department of Pediatric Dentistry
-
Contact:
- Sean M Sebourn, DDS
- Phone Number: 504-941-8199
- Email: ssebou@lsuhsc.edu
-
Contact:
- Suzanne Fournier, DDS
- Phone Number: 504-430-4300
- Email: sfour1@lsuhsc.edu
-
Principal Investigator:
- Suzanne E Fournier, DDS
-
Sub-Investigator:
- Sean M Sebourn, DDS
-
Sub-Investigator:
- Zafer C Cehreli, DDS, PhD
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 16 years (Child)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Teeth having a clinical indication of sealing with bonded resin pit and fissure sealants
- Patients with four fully-erupted permanent molars, with unstained, caries-free and unsealed pit and fissures
Exclusion Criteria:
- Patients having incipient carious lesions, fewer erupted molars or teeth without pits on buccal/palatal surfaces.
- Patients with systemic diseases.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Rubber Dam
Isolation of single tooth using rubber dam
|
Rubber dam set is the generic name of an isolation device that consists of a rubber sheet that isolates the tooth from saliva, a clamp to hold the rubber sheet on the tooth to be isolated, and a metal frame to keep the rubber sheet in a stretched position during dental procedures.
|
Active Comparator: Cotton Roll
Isolation of quadrant using cotton rolls
|
Cotton roll is the generic name of a disposable isolation device made of cotton in a cylindrical form.
Cotton rolls are used to isolate the teeth from saliva, by being placed in the cheek and tongue during placement of sealants or filings.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The US Public Health Service criteria for retention of sealants
Time Frame: 12 months
|
Alpha: No Loss of sealant, Bravo: Partial Loss of Sealant, Charlie: Total loss of sealant
|
12 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The US Public Health Service criteria for secondary caries on sealants
Time Frame: 12 months
|
Alpha: Charlie: There is no clinical diagnosis of caries.
Charlie: There is clinical diagnosis of caries
|
12 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
February 1, 2020
Primary Completion (Anticipated)
June 1, 2021
Study Completion (Anticipated)
June 1, 2021
Study Registration Dates
First Submitted
February 21, 2019
First Submitted That Met QC Criteria
March 21, 2019
First Posted (Actual)
March 22, 2019
Study Record Updates
Last Update Posted (Actual)
November 5, 2019
Last Update Submitted That Met QC Criteria
November 4, 2019
Last Verified
November 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- RDI vs cotton roll
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
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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