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

NCT ID: NCT03886727

Last Updated: 2019-11-05

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

50 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-01

Study Completion Date

2021-06-01

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

OTHER

Blinding Strategy

SINGLE

Participants

Study Groups

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Rubber Dam

Isolation of single tooth using rubber dam

Group Type ACTIVE_COMPARATOR

Rubber Dam Set

Intervention Type DEVICE

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.

Cotton Roll

Isolation of quadrant using cotton rolls

Group Type ACTIVE_COMPARATOR

Dental Cotton Roll

Intervention Type DEVICE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type DEVICE

Eligibility Criteria

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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.
Minimum Eligible Age

6 Years

Maximum Eligible Age

16 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Zafer Cavit Cehreli, DDS, PhD

OTHER

Sponsor Role lead

Responsible Party

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Zafer Cavit Cehreli, DDS, PhD

Clinical Professor

Responsibility Role SPONSOR_INVESTIGATOR

Locations

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LSU School of Dentistry, Department of Pediatric Dentistry

New Orleans, Louisiana, United States

Site Status

Countries

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United States

Facility Contacts

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Sean M Sebourn, DDS

Role: primary

504-941-8199

Suzanne Fournier, DDS

Role: backup

504-430-4300

Other Identifiers

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RDI vs cotton roll

Identifier Type: -

Identifier Source: org_study_id

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