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Completed

NCT Number: NCT02795728

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

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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Key information

Conditions

Dental Caries Stomatognathic Diseases Tooth Demineralization Tooth Diseases

Age range

7 year–9 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Sri Sai college of Dental surgery

Vikārābād, Telangana, 501101, India

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Application of the GIC based sealant

Other

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

Resin based sealant

Other

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

Primary outcomes

  1. Retention of the sealant

    Time frame: Baseline to 1 year

    Retention of the sealants will be assessed by using the Simensons criteria

Secondary outcomes

  1. Caries incidence

    Time frame: Baseline to 1 year

Sponsors and collaborators

Lead sponsor

Kamineni Institute of Dental Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Jun 10, 2016
Registry last updated
Jun 10, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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