Effectiveness of Rubber Dam Isolation Versus Cotton Roll Isolation on Bonded Fissure Sealant Retention

Not Applicable

• Conditions: Dental Caries in Children; Dental Leakage; Dental Caries on Pit and Fissure Surface
• Interventions: Device: Dental Cotton Roll; Device: Rubber Dam Set

• Registration Number: NCT03886727
• Lead Sponsor: Zafer Cavit Cehreli, DDS, PhD

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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2019-02-21
• Study First Submitted QC: 2019-03-21
• Study First Posted: 2019-03-22
• Status Verified: 2019-11
• Last Update Submitted: 2019-11-04
• Last Update Posted: 2019-11-05
• Study Start: 2020-02-01
• Primary Completion: 2021-06-01
• Study Completion: 2021-06-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 50

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Cotton Roll	Dental Cotton Roll	Isolation of quadrant using cotton rolls
Rubber Dam	Rubber Dam Set	Isolation of single tooth using rubber dam

Primary Outcome Measures

Name	Time	Method
The US Public Health Service criteria for retention of sealants	12 months	Alpha: No Loss of sealant, Bravo: Partial Loss of Sealant, Charlie: Total loss of sealant

Secondary Outcome Measures

Name	Time	Method
The US Public Health Service criteria for secondary caries on sealants	12 months	Alpha: Charlie: There is no clinical diagnosis of caries. Charlie: There is clinical diagnosis of caries

Trial Locations

Locations (1)

LSU School of Dentistry, Department of Pediatric Dentistry; 🇺🇸 New Orleans, Louisiana, United States