NCT03989687

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
18

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jul 2019

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

June 14, 2019

Completed
4 days until next milestone

First Posted

Study publicly available on registry

June 18, 2019

Completed
13 days until next milestone

Study Start

First participant enrolled

July 1, 2019

Completed
1 year until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 30, 2020

Completed
Last Updated

June 18, 2019

Status Verified

June 1, 2019

Enrollment Period

1 year

First QC Date

June 14, 2019

Last Update Submit

June 14, 2019

Conditions

Dental Caries in Children

Outcome Measures

Primary Outcomes (1)

  • retention rate of sealants

    retention rate for sealants placed with different modes of isolation

    6 months

Study Arms (2)

glass ionomer sealant

EXPERIMENTAL

glass ionomer sealant

Other: isolation

isolation

EXPERIMENTAL

isolation type either rubber dam or cotton roll isolation

Device: Fuji Triage

Interventions

Fuji TriageDEVICE

glass ionomer sealant

Also known as: Fuji VII
isolation
isolationOTHER

rubber dam or cotton roll isolation

glass ionomer sealant

Eligibility Criteria

Age5 Years - 10 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17)

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Officials

  • Suzanne Fournier, DDS

    LSUHSC

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Suzanne E Fournier, DDS

CONTACT

504-941-8199sfour1@lsuhsc.edu

Daniel Kim, 'DMD

CONTACT

504-941-8199dkim5@lsuhsc.edu

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Masking Details
The evaluator will not have knowledge of which type of isolation was used when placing the sealants.
Purpose
PREVENTION
Intervention Model
SINGLE GROUP
Model Details: each patient is serving as their own control
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

June 14, 2019

First Posted

June 18, 2019

Study Start

July 1, 2019

Primary Completion

June 30, 2020

Study Completion

June 30, 2020

Last Updated

June 18, 2019

Record last verified: 2019-06

Data Sharing

IPD Sharing
Will not share