NCT03886727UnknownNot Applicable
Clinical Retention of Bonded Resin Sealants Placed With Rubber Dam Versus Cotton Roll Isolation
Zafer Cavit Cehreli, DDS, PhD1 site in 1 country50 target enrollmentStarted: February 1, 2020Last updated:
Conditions
Interventions
Trial Snapshot
- Phase
- Not Applicable
- Sponsor
- Enrollment
- 50
- Locations
- 1
- Primary Endpoint
- The US Public Health Service criteria for retention of sealants
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Other
- Masking
- Single (Participant)
Eligibility Criteria
- Ages
- 6 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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.
Arms & Interventions
Cotton Roll
Active Comparator
Isolation of quadrant using cotton rolls
Intervention: Dental Cotton Roll (Device)
Rubber Dam
Active Comparator
Isolation of single tooth using rubber dam
Intervention: Rubber Dam Set (Device)
Outcomes
Primary Outcomes
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
Secondary Outcomes
- The US Public Health Service criteria for secondary caries on sealants(12 months)
Investigators
Zafer Cavit Cehreli, DDS, PhD
Clinical Professor
Hacettepe University
Study Sites (1)
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