Clincosm LogoSign in Get a demo

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

Sponsor
Zafer Cavit Cehreli, DDS, PhD (Other)
Overall Status
Unknown status
CT.gov ID
NCT03886727
Collaborator
(none)
50
Enrollment
1
Location
2
Arms
16
Anticipated Duration (Months)
3.1
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Rubber Dam Set
  • Device: Dental Cotton Roll
 N/A

Study Design

Study Type:
Interventional
Anticipated Enrollment :
50 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Single (Participant)
Primary Purpose:
Other
Official Title:
Clinical Retention of Bonded Resin Sealants Placed With Rubber Dam Versus Cotton Roll Isolation
Anticipated Study Start Date :
Feb 1, 2020
Anticipated Primary Completion Date :
Jun 1, 2021
Anticipated Study Completion Date :
Jun 1, 2021

Arms and Interventions

Arm Intervention/Treatment
Active Comparator: Rubber Dam

Isolation of single tooth using rubber dam

Device: Rubber Dam Set
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

Device: Dental Cotton Roll
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.

Outcome Measures

Primary Outcome Measures

  1. 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

  1. 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

Eligibility Criteria

Criteria

Ages Eligible for Study:
6 Years to 16 Years
Sexes Eligible for Study:
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.

Contacts and Locations

Locations

Site City State Country Postal Code
1 LSU School of Dentistry, Department of Pediatric Dentistry New Orleans Louisiana United States 70119

Sponsors and Collaborators

  • Zafer Cavit Cehreli, DDS, PhD

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.
Responsible Party:
Zafer Cavit Cehreli, DDS, PhD, Clinical Professor, Hacettepe University
ClinicalTrials.gov Identifier:
NCT03886727
Other Study ID Numbers:
  • RDI vs cotton roll
First Posted:
Mar 22, 2019
Last Update Posted:
Nov 5, 2019
Last Verified:
Nov 1, 2019
Individual Participant Data (IPD) Sharing Statement:
No
Plan to Share IPD:
No
Studies a U.S. FDA-regulated Drug Product:
No
Studies a U.S. FDA-regulated Device Product:
Yes
Additional relevant MeSH terms:
Dental Caries
Dental Leakage

Study Results

No Results Posted as of Nov 5, 2019