Effectiveness of Rubber Dam Isolation Versus Cotton Roll Isolation on Bonded Fissure Sealant Retention
Clinical Retention of Bonded Resin Sealants Placed With Rubber Dam Versus Cotton Roll Isolation
1 other identifier
interventional
50
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
February 21, 2019
CompletedFirst Posted
Study publicly available on registry
March 22, 2019
CompletedStudy Start
First participant enrolled
February 1, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2021
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedNovember 5, 2019
November 1, 2019
1.3 years
February 21, 2019
November 4, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
The US Public Health Service criteria for retention of sealants
Alpha: No Loss of sealant, Bravo: Partial Loss of Sealant, Charlie: Total loss of sealant
12 months
Secondary Outcomes (1)
The US Public Health Service criteria for secondary caries on sealants
12 months
Study Arms (2)
Rubber Dam
ACTIVE COMPARATORIsolation of single tooth using rubber dam
Cotton Roll
ACTIVE COMPARATORIsolation of quadrant using cotton rolls
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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
You may not qualify if:
- Patients having incipient carious lesions, fewer erupted molars or teeth without pits on buccal/palatal surfaces.
- Patients with systemic diseases.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
LSU School of Dentistry, Department of Pediatric Dentistry
New Orleans, Louisiana, 70119, United States
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- PARTICIPANT
- Purpose
- OTHER
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Clinical Professor
Study Record Dates
First Submitted
February 21, 2019
First Posted
March 22, 2019
Study Start
February 1, 2020
Primary Completion
June 1, 2021
Study Completion
June 1, 2021
Last Updated
November 5, 2019
Record last verified: 2019-11
Data Sharing
- IPD Sharing
- Will not share