Fuji Type VII Sealant Versus Resin Based Sealant. A Clinical Trial

Phase 4

Completed

• Conditions: Dental Caries
• Interventions: Other: Resin based sealant; Other: Application of the GIC based sealant

• Registration Number: NCT02795728
• Lead Sponsor: Kamineni Institute of Dental Sciences

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2010-02
• Primary Completion: 2011-03
• Study Completion: 2011-03
• Status Verified: 2016-05
• Study First Submitted: 2016-05-28
• Study First Submitted QC: 2016-06-09
• Last Update Submitted: 2016-06-09
• Study First Posted: 2016-06-10
• Last Update Posted: 2016-06-10

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 120

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Resin based sealant	Resin based sealant	Helioseal F is a resin based sealant
Experimental arm	Application of the GIC based sealant	Fuji type VII is a GIC based sealant with an additional property of high fluoride release

Primary Outcome Measures

Name	Time	Method
Retention of the sealant	Baseline to 1 year	Retention of the sealants will be assessed by using the Simensons criteria

Secondary Outcome Measures

Name	Time	Method
Caries incidence	Baseline to 1 year

Trial Locations

Locations (1)

Sri Sai college of Dental surgery; 🇮🇳 Vikarabad, Telangana, India