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NCT02063815 Clinical Trial

A Trial of Caries Prevention Effect of Fissure Sealants

Caries Prevention Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT02063815
Other study ID # SAG-A-040609-0167
Secondary ID
Status Completed
Phase N/A
First received February 13, 2014
Last updated February 13, 2014
Start date June 2009
Est. completion date February 2013

Study information
Verified date February 2014
Source Marmara University
Contact n/a
Is FDA regulated No
Health authority Turkey: Ethics Committee
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 40
Est. completion date February 2013
Est. primary completion date February 2012
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 6 Years to 10 Years
Eligibility 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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention

Related Conditions & MeSH terms

Intervention

Procedure:
• Fissure sealant application

Locations
Country Name City State
n/a

Sponsors (1)
Lead Sponsor Collaborator
Marmara University

Outcome
Type Measure Description Time frame Safety issue
Primary Change from Baseline in Fluoride concentration of saliva 1 week, 6. months, 12. months Yes
See also
  Status Clinical Trial Phase
Completed NCT04854720 - Clinical Efficacy of Different Fissure Sealant Materials in the Newly Erupted Non-Carious First Permanent Molars N/A
Recruiting NCT05336162 - Retention Rate and Caries Preventive Effect of Self Etch Giomer Based Fissure Sealant N/A
Completed NCT03718689 - Effect of Er:YAG Laser on Hydrophilic Sealants N/A
Active, not recruiting NCT03235960 - Efficacy of Glass-ionomer Fissure Sealants N/A