Clinical Retention of Glass Ionomer Sealants Placed With and Without Rubber Dam: a Comparative Analysis

NCT ID: NCT03989687

Last Updated: 2019-06-18

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

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-01

Study Completion Date

2020-06-30

Brief Summary

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A comparative analysis of glass ionomer sealant placed on permanent molars with and without a rubber dam to assess the retention over a 2 year period.

Detailed Description

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The purpose of the study is to compare the retention rates of glass ionomer sealants placed on first permanent molars over a period of 2 years. Pediatric patients (under \<10 years of age) will receive a glass ionomer sealant on all four permanent first molars. One side will be randomly selected with rubber dam isolation and the contralateral side will have no rubber dam isolation for the placement of the sealant. Over a 2 year period, every 6 months the sealants will be assessed for retention.

The glass ionomer sealant material will be Fuji Triage (GC America). The following dental materials that will be used are cotton rolls, non-latex rubber dam, topical benzocaine, dental mirror, glass ionomer dispensing gun, dental explorer, triturator for the glass ionomer, cotton gauze, suction tip, air-water syringe.

Conditions

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Dental Caries in Children

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

SINGLE_GROUP

each patient is serving as their own control
Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors
The evaluator will not have knowledge of which type of isolation was used when placing the sealants.

Study Groups

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glass ionomer sealant

glass ionomer sealant

Group Type EXPERIMENTAL

isolation

Intervention Type OTHER

rubber dam or cotton roll isolation

isolation

isolation type either rubber dam or cotton roll isolation

Group Type EXPERIMENTAL

Fuji Triage

Intervention Type DEVICE

glass ionomer sealant

Interventions

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Fuji Triage

glass ionomer sealant

Intervention Type DEVICE

isolation

rubber dam or cotton roll isolation

Intervention Type OTHER

Other Intervention Names

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Fuji VII

Eligibility Criteria

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Inclusion Criteria

\-

Exclusion Criteria

\-
Minimum Eligible Age

5 Years

Maximum Eligible Age

10 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Louisiana State University Health Sciences Center in New Orleans

OTHER

Sponsor Role lead

Responsible Party

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Suzanne E Fournier

Assistant Professor

Responsibility Role PRINCIPAL_INVESTIGATOR

Principal Investigators

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Suzanne Fournier, DDS

Role: PRINCIPAL_INVESTIGATOR

LSUHSC

Central Contacts

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Suzanne E Fournier, DDS

Role: CONTACT

504-941-8199

Daniel Kim, 'DMD

Role: CONTACT

504-941-8199

Other Identifiers

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19-138

Identifier Type: -

Identifier Source: org_study_id

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