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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT03886727
Other study ID # RDI vs cotton roll
Secondary ID
Status Not yet recruiting
Phase N/A
First received
Last updated
Start date February 1, 2020
Est. completion date June 1, 2021

Study information

Verified date November 2019
Source Hacettepe University
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Not yet recruiting
Enrollment 50
Est. completion date June 1, 2021
Est. primary completion date June 1, 2021
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 6 Years to 16 Years
Eligibility 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


Related Conditions & MeSH terms


Intervention

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.
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.

Locations

Country Name City State
United States LSU School of Dentistry, Department of Pediatric Dentistry New Orleans Louisiana

Sponsors (1)

Lead Sponsor Collaborator
Zafer Cavit Cehreli, DDS, PhD

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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 The US Public Health Service criteria for secondary caries on sealants Alpha: Charlie: There is no clinical diagnosis of caries. Charlie: There is clinical diagnosis of caries 12 months
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