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

Primary Purpose

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

Status

Unknown status

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

Rubber Dam Set

Dental Cotton Roll

About this trial

This is an interventional other trial for Dental Caries in Children

Eligibility Criteria

6 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

LSU School of Dentistry, Department of Pediatric Dentistry

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Rubber Dam

Cotton Roll

Arm Description

Isolation of single tooth using rubber dam

Isolation of quadrant using cotton rolls

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

NCT ID

NCT03886727

First Posted

February 21, 2019

Last Updated

November 4, 2019

Sponsor

Zafer Cavit Cehreli, DDS, PhD

1. Study Identification

Unique Protocol Identification Number

NCT03886727

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

November 2019

Overall Recruitment Status

Unknown status

Study Start Date

February 1, 2020 (Anticipated)

Primary Completion Date

June 1, 2021 (Anticipated)

Study Completion Date

June 1, 2021 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor-Investigator

Name of the Sponsor

Zafer Cavit Cehreli, DDS, PhD

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Yes

5. 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

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

7. Study Design

Primary Purpose

Other

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

50 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Rubber Dam

Arm Type

Active Comparator

Arm Description

Isolation of single tooth using rubber dam

Arm Title

Cotton Roll

Arm Type

Active Comparator

Arm Description

Isolation of quadrant using cotton rolls

Intervention Type

Device

Intervention Name(s)

Rubber Dam Set

Intervention Description

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.

Intervention Type

Device

Intervention Name(s)

Dental Cotton Roll

Intervention Description

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.

Primary Outcome Measure Information:

Title

The US Public Health Service criteria for retention of sealants

Description

Alpha: No Loss of sealant, Bravo: Partial Loss of Sealant, Charlie: Total loss of sealant

Time Frame

12 months

Secondary Outcome Measure Information:

Title

The US Public Health Service criteria for secondary caries on sealants

Description

Alpha: Charlie: There is no clinical diagnosis of caries. Charlie: There is clinical diagnosis of caries

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

6 Years

Maximum Age & Unit of Time

16 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

Facility Information:

Facility Name

LSU School of Dentistry, Department of Pediatric Dentistry

City

New Orleans

State/Province

Louisiana

ZIP/Postal Code

70119

Country

United States

Facility Contact: