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

Primary Purpose

Dental Caries in Children

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Fuji Triage

isolation

About this trial

This is an interventional prevention trial for Dental Caries in Children

Eligibility Criteria

5 Years - 10 Years (Child)All SexesAccepts Healthy Volunteers

Inclusion Criteria: healthy children who need sealants on 4 permanent molars that are not hypo plastic, are caries-free, and with no enamel defects.

Exclusion Criteria: hypoplastic molars, caries, teeth with existing restorations, and those with enamel defects,

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Arm Label

glass ionomer sealant

isolation

Arm Description

glass ionomer sealant

isolation type either rubber dam or cotton roll isolation

Outcomes

Primary Outcome Measures

retention rate of sealants

retention rate for sealants placed with different modes of isolation

Secondary Outcome Measures

Full Information

NCT ID

NCT03989687

First Posted

June 14, 2019

Last Updated

June 14, 2019

Sponsor

Louisiana State University Health Sciences Center in New Orleans

1. Study Identification

Unique Protocol Identification Number

NCT03989687

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

June 2019

Overall Recruitment Status

Unknown status

Study Start Date

July 1, 2019 (Anticipated)

Primary Completion Date

June 30, 2020 (Anticipated)

Study Completion Date

June 30, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Louisiana State University Health Sciences Center in New Orleans

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Studies a U.S. FDA-regulated Device Product

Product Manufactured in and Exported from the U.S.

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

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

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.

6. Conditions and Keywords

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

Dental Caries in Children

7. Study Design

Primary Purpose

Prevention

Study Phase

Not Applicable

Interventional Study Model

Single Group Assignment

Model Description

each patient is serving as their own control

Masking

Outcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

18 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

glass ionomer sealant

Arm Type

Experimental

Arm Description

glass ionomer sealant

Arm Title

isolation

Arm Type

Experimental

Arm Description

isolation type either rubber dam or cotton roll isolation

Intervention Type

Device

Intervention Name(s)

Fuji Triage

Other Intervention Name(s)

Fuji VII

Intervention Description

glass ionomer sealant

Intervention Type

Other

Intervention Name(s)

isolation

Intervention Description

rubber dam or cotton roll isolation

Primary Outcome Measure Information:

Title

retention rate of sealants

Description

retention rate for sealants placed with different modes of isolation

Time Frame

6 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

5 Years

Maximum Age & Unit of Time

10 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: healthy children who need sealants on 4 permanent molars that are not hypo plastic, are caries-free, and with no enamel defects. - Exclusion Criteria: hypoplastic molars, caries, teeth with existing restorations, and those with enamel defects, -

Central Contact Person:

First Name & Middle Initial & Last Name or Official Title & Degree

Suzanne E Fournier, DDS

Phone

504-941-8199

sfour1@lsuhsc.edu

First Name & Middle Initial & Last Name or Official Title & Degree

Daniel Kim, 'DMD

Phone

504-941-8199

dkim5@lsuhsc.edu

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Suzanne Fournier, DDS

Organizational Affiliation

LSUHSC

Official's Role

Principal Investigator

12. IPD Sharing Statement

Plan to Share IPD

Learn more about this trial

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

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