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Clinical Trials/NCT02063815
NCT02063815CompletedNot Applicable

A Randomized Controlled Trial of Caries Prevention Effect of a Glass Ionomer Sealant Versus a Resin Sealant

Marmara University0 sites40 target enrollmentStarted: June 1, 2009Last updated:
Conditions
Interventions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
40
Primary Endpoint
Change from Baseline in Fluoride concentration of saliva

Study Overview

Brief Summary

The purpose of this randomized clinical trial was to compare caries prevention of a conventional resin-based sealant and a glass-ionomer sealant placed on occlusal pits and fissures over a one year period in a high caries children group. Additionally the concentration of Fluoride in saliva was evaluated.

Study Design

Study Type
Interventional
Allocation
Randomized
Intervention Model
Parallel
Primary Purpose
Prevention
Masking
Single (Participant)

Eligibility Criteria

Ages
6 Years to 10 Years (Child)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • •1.Age range of 6 to 10 years 2.Having caries free, fully erupted first permanent molars 3.Deep and/or intermediate pits or fissures 4.dft ≥ 2

Exclusion Criteria

  • •1.Having any systemic disease 2.Topical fluoride was applied last six months 3.dft = 0

Arms & Interventions

glass ionomer based fissure sealant

Active Comparator

fissure sealant application

Intervention: Fissure sealant application (Procedure)

resin based fissure sealant

Active Comparator

fissure sealant application

Intervention: Fissure sealant application (Procedure)

Outcomes

Primary Outcomes

Change from Baseline in Fluoride concentration of saliva

Time Frame: 1 week, 6. months, 12. months

Secondary Outcomes

No secondary outcomes reported

Investigators

Sponsor Class
Other
Responsible Party
Sponsor

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