A Trial of Caries Prevention Effect of Fissure Sealants

• Sponsor: Marmara University (Other)
• Overall Status: Completed
• CT.gov ID: NCT02063815
• Collaborator: (none)
• Enrollment: 40
• Arms: 2
• Duration (Months): 44.1

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Caries Prevention; Fissure Sealant; Fluoride Concentration; Glass Ionomer Cement; Resin	Procedure: Fissure sealant application	N/A

Study Design

• Study Type: Interventional
• Actual Enrollment: 40 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Single (Participant)
• Primary Purpose: Prevention
• Official Title: A Randomized Controlled Trial of Caries Prevention Effect of a Glass Ionomer Sealant Versus a Resin Sealant
• Study Start Date: Jun 1, 2009
• Actual Primary Completion Date: Feb 1, 2012
• Actual Study Completion Date: Feb 1, 2013

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: glass ionomer based fissure sealant fissure sealant application	Procedure: Fissure sealant application
Active Comparator: resin based fissure sealant fissure sealant application	Procedure: Fissure sealant application

Outcome Measures

Primary Outcome Measures

1. Change from Baseline in Fluoride concentration of saliva [1 week, 6. months, 12. months]

Eligibility Criteria

Criteria

• Ages Eligible for Study: 6 Years to 10 Years
• Sexes Eligible for Study: 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

Contacts and Locations

Locations

No locations specified.

Sponsors and Collaborators

• Marmara University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Marmara University
• ClinicalTrials.gov Identifier: NCT02063815
• Other Study ID Numbers: SAG-A-040609-0167
• First Posted: Feb 14, 2014
• Last Update Posted: Feb 14, 2014
• Last Verified: Feb 1, 2014

Study Results

No Results Posted as of Feb 14, 2014