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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

120 participants

Study Classification

INTERVENTIONAL

Study Start Date

2010-02-28

Study Completion Date

2011-03-31

Brief Summary

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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.

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Detailed Description

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Conditions

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Dental Caries

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

DOUBLE

Investigators Outcome Assessors

Study Groups

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Experimental arm

Fuji type VII is a GIC based sealant with an additional property of high fluoride release

Group Type EXPERIMENTAL

Application of the GIC based sealant

Intervention Type OTHER

Application of the GIC based sealant was carried out according to the manufacturer's instructions.

Resin based sealant

Helioseal F is a resin based sealant

Group Type ACTIVE_COMPARATOR

Resin based sealant

Intervention Type OTHER

Application of the resin based sealant on the occlusal surfaces was carried out as per the manufacturer s recommendations.

Interventions

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Application of the GIC based sealant

Application of the GIC based sealant was carried out according to the manufacturer's instructions.

Intervention Type OTHER

Resin based sealant

Application of the resin based sealant on the occlusal surfaces was carried out as per the manufacturer s recommendations.

Intervention Type OTHER

Eligibility Criteria

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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.