Fuji Type VII Sealant Versus Resin Based Sealant. A Clinical Trial
Fuji Type VII Sealants Versus Resin Based Sealants. A Clinical Trial
1 other identifier
interventional
120
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for phase_4
Started Feb 2010
Shorter than P25 for phase_4
1 active site
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
Study Start
First participant enrolled
February 1, 2010
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2011
CompletedStudy Completion
Last participant's last visit for all outcomes
March 1, 2011
CompletedFirst Submitted
Initial submission to the registry
May 28, 2016
CompletedFirst Posted
Study publicly available on registry
June 10, 2016
CompletedJune 10, 2016
May 1, 2016
1.1 years
May 28, 2016
June 9, 2016
Conditions
Outcome Measures
Primary Outcomes (1)
Retention of the sealant
Retention of the sealants will be assessed by using the Simensons criteria
Baseline to 1 year
Secondary Outcomes (1)
Caries incidence
Baseline to 1 year
Study Arms (2)
Experimental arm
EXPERIMENTALFuji type VII is a GIC based sealant with an additional property of high fluoride release
Resin based sealant
ACTIVE COMPARATORHelioseal F is a resin based sealant
Interventions
Application of the GIC based sealant was carried out according to the manufacturer's instructions.
Application of the resin based sealant on the occlusal surfaces was carried out as per the manufacturer s recommendations.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- Molars with developmental anomalies, hypoplastic teeth were promptly excluded
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Sri Sai college of Dental surgery
Vikārābād, Telangana, 501101, India
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Prathibha Rao, MDS
Sri Sai college of Dental surgery
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assistant Professor
Study Record Dates
First Submitted
May 28, 2016
First Posted
June 10, 2016
Study Start
February 1, 2010
Primary Completion
March 1, 2011
Study Completion
March 1, 2011
Last Updated
June 10, 2016
Record last verified: 2016-05
Data Sharing
- IPD Sharing
- Will share