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

Dental Caries in Children Clinical Trial

Official title:

Clinical Retention of Bonded Resin Sealants Placed With Rubber Dam Versus Cotton Roll Isolation

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT03886727
• Other study ID #: RDI vs cotton roll
• Status: Not yet recruiting
• Phase: N/A
• 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
• 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.

Related Conditions & MeSH terms

• Dental Caries
• Dental Caries in Children
• Dental Caries on Pit and Fissure Surface
• Dental Leakage

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