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

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

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 Overview

• Status: Unknown
• Conditions: Dental Caries in Children; Dental Caries on Pit and Fissure Surface; Dental Leakage
• Intervention / Treatment: Device: Rubber Dam Set; Device: Dental Cotton Roll

• Study Type: Interventional
• Enrollment (Anticipated): 50
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • Louisiana
    • New Orleans, Louisiana, United States, 70119
      • LSU School of Dentistry, Department of Pediatric Dentistry

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 6 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Other
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: Zafer Cavit Cehreli, DDS, PhD

Study record dates

Study Major Dates

• Study Start (Anticipated): February 1, 2020
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): June 1, 2021

Study Registration Dates

• First Submitted: February 21, 2019
• First Submitted That Met QC Criteria: March 21, 2019
• First Posted (Actual): March 22, 2019

Study Record Updates

• Last Update Posted (Actual): November 5, 2019
• Last Update Submitted That Met QC Criteria: November 4, 2019
• Last Verified: November 1, 2019

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Dental Caries; Dental Leakage
• Other Study ID Numbers: RDI vs cotton roll

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: No

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes