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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02795728
Recruitment Status : Completed
First Posted : June 10, 2016
Last Update Posted : June 10, 2016
Sponsor:
Information provided by (Responsible Party):
Dr. Praveen B.H, 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.

Condition or disease Intervention/treatment Phase
Dental Caries Other: Application of the GIC based sealant Other: Resin based sealant Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 120 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Official Title: Fuji Type VII Sealants Versus Resin Based Sealants. A Clinical Trial
Study Start Date : February 2010
Actual Primary Completion Date : March 2011
Actual Study Completion Date : March 2011

Arm Intervention/treatment
Experimental: Experimental arm
Fuji type VII is a GIC based sealant with an additional property of high fluoride release
Other: Application of the GIC based sealant
Application of the GIC based sealant was carried out according to the manufacturer's instructions.

Active Comparator: Resin based sealant
Helioseal F is a resin based sealant
Other: Resin based sealant
Application of the resin based sealant on the occlusal surfaces was carried out as per the manufacturer s recommendations.




Primary Outcome Measures :
  1. Retention of the sealant [ Time Frame: Baseline to 1 year ]
    Retention of the sealants will be assessed by using the Simensons criteria


Secondary Outcome Measures :
  1. Caries incidence [ Time Frame: Baseline to 1 year ]


Information from the National Library of Medicine

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Ages Eligible for Study:   7 Years to 9 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02795728


Locations
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India
Sri Sai college of Dental surgery
Vikarabad, Telangana, India, 501101
Sponsors and Collaborators
Kamineni Institute of Dental Sciences
Investigators
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Study Director: Prathibha Rao, MDS Sri Sai college of Dental surgery
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Responsible Party: Dr. Praveen B.H, Assistant Professor, Kamineni Institute of Dental Sciences
ClinicalTrials.gov Identifier: NCT02795728    
Other Study ID Numbers: SSCDS
First Posted: June 10, 2016    Key Record Dates
Last Update Posted: June 10, 2016
Last Verified: May 2016
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Additional relevant MeSH terms:
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Dental Caries
Tooth Demineralization
Tooth Diseases
Stomatognathic Diseases