Back to resultsFuji Type VII Sealant Versus Resin Based Sealant. A Clinical Trial
Primary Purpose
Dental Caries
Status
Completed
Phase
Phase 4
Locations
India
Study Type
Interventional
Intervention
Application of the GIC based sealant
Resin based sealant
Sponsored by
About this trial
This is an interventional prevention trial for Dental Caries
Eligibility Criteria
Inclusion Criteria:
- Children with a fully erupted contra lateral permanent mandibular first molars with well-defined deep pits and fissures and molars free of mucosal tissue are included in the study.
Exclusion Criteria:
- Molars with developmental anomalies, hypoplastic teeth were promptly excluded
Sites / Locations
- Sri Sai college of Dental surgery
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Experimental arm
Resin based sealant
Arm Description
Fuji type VII is a GIC based sealant with an additional property of high fluoride release
Helioseal F is a resin based sealant
Outcomes
Primary Outcome Measures
Retention of the sealant
Retention of the sealants will be assessed by using the Simensons criteria
Secondary Outcome Measures
Caries incidence
Full Information
NCT ID
NCT02795728
First Posted
May 28, 2016
Last Updated
June 9, 2016
Sponsor
Kamineni Institute of Dental Sciences
1. Study Identification
Unique Protocol Identification Number
NCT02795728
Brief Title
Fuji Type VII Sealant Versus Resin Based Sealant. A Clinical Trial
Official Title
Fuji Type VII Sealants Versus Resin Based Sealants. A Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2016
Overall Recruitment Status
Completed
Study Start Date
February 2010 (undefined)
Primary Completion Date
March 2011 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Kamineni Institute of Dental Sciences
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
Purpose: To evaluate the retention and caries preventive effect of the glass-ionomer fissure sealants and resin-based fissure sealant. Materials and Methods: Using a split mouth design ,a double blind randomized controlled clinical trial was conducted to compare the retention and the caries preventive effect of light cure resin base sealant (3M ESPE) and Glass ionomer sealant (FUJI). The study comprised of 120 government school children of 7-9 years age group. The glass-ionomer sealant and resin-based sealant were applied randomly on either side of the first mandibular permanent molars. They were recalled for assessment of sealant retention at intervals of 3, 6 and 12 months.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Dental Caries
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
InvestigatorOutcomes Assessor
Allocation
Randomized
Enrollment
120 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Experimental arm
Arm Type
Experimental
Arm Description
Fuji type VII is a GIC based sealant with an additional property of high fluoride release
Arm Title
Resin based sealant
Arm Type
Active Comparator
Arm Description
Helioseal F is a resin based sealant
Intervention Type
Other
Intervention Name(s)
Application of the GIC based sealant
Intervention Description
Application of the GIC based sealant was carried out according to the manufacturer's instructions.
Intervention Type
Other
Intervention Name(s)
Resin based sealant
Intervention Description
Application of the resin based sealant on the occlusal surfaces was carried out as per the manufacturer s recommendations.
Primary Outcome Measure Information:
Title
Retention of the sealant
Description
Retention of the sealants will be assessed by using the Simensons criteria
Time Frame
Baseline to 1 year
Secondary Outcome Measure Information:
Title
Caries incidence
Time Frame
Baseline to 1 year
10. Eligibility
Sex
All
Minimum Age & Unit of Time
7 Years
Maximum Age & Unit of Time
9 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Children with a fully erupted contra lateral permanent mandibular first molars with well-defined deep pits and fissures and molars free of mucosal tissue are included in the study.
Exclusion Criteria:
Molars with developmental anomalies, hypoplastic teeth were promptly excluded
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Prathibha Rao, MDS
Organizational Affiliation
Sri Sai college of Dental surgery
Official's Role
Study Director
Facility Information:
Facility Name
Sri Sai college of Dental surgery
City
Vikarabad
State/Province
Telangana
ZIP/Postal Code
501101
Country
India
12. IPD Sharing Statement
Plan to Share IPD
Yes
Learn more about this trial
Fuji Type VII Sealant Versus Resin Based Sealant. A Clinical Trial
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