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A Clinical Trial to Assess the Retention and Caries Preventive Effects of Moisture Tolerant Resin Sealant and ART Sealants

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: NCT02716558
Recruitment Status : Completed
First Posted : March 23, 2016
Last Update Posted : June 26, 2018
Sponsor:
Collaborator:
Nathajirao G. Halgekar Institute of Dental Sciences & Research centre, Karnataka, India
Information provided by (Responsible Party):
Dr. Praveen B.H, Kamineni Institute of Dental Sciences

Brief Summary:
It is a clinical trial which employs a split mouth design to assess the retention of a moisture tolerant resin based sealant and the ART(Atraumatic restorative treatment) sealants on a representative sample of 7- 12 year old school children of a district in Belgaum, Karnataka, India.

Condition or disease Intervention/treatment Phase
Retention Other: ART Sealant Application Other: Resin sealant application Phase 3

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 93 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Investigator, Outcomes Assessor)
Primary Purpose: Prevention
Study Start Date : February 2016
Actual Primary Completion Date : March 2017
Actual Study Completion Date : April 2017

Arm Intervention/treatment
Experimental: Moisture tolerant resin sealant
Moisture resistant sealant (wet bond sealant)
Other: Resin sealant application
application of the moisture tolerant sealant according to the manufacturers instructions.

Active Comparator: ART sealant
Glass inomer based sealant
Other: ART Sealant Application
application of the ART sealant using high viscosity glass inomer cements.




Primary Outcome Measures :
  1. Retention of the sealants [ Time Frame: Baseline to 1 year ]
    The retention of the sealants will be assessed by using the MODIFIED SIMENSONS CRITERIA



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Ages Eligible for Study:   7 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Subjects with fully erupted contralateral permanent mandibular first molars with well defined deep irregular pits and fissures. The entire tooth surface should be visible in the mouth and free of mucosal tissue.

Exclusion Criteria:

  • An open carious lesion exists.
  • A large occlusal restoration if already present.
  • Presence of caries on the other surfaces of the same tooth.
  • Subjects with developmental anomalies and hypoplastic permanent first molars.
  • Subjects who were suffering from any systemic disease or those who were on any long term medication.

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): NCT02716558


Locations
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India
Maratha Mandal's Nathajirao G. Halgekar Institute of Dental Sciences & Research Centre.
Belgaum, Karnataka, India, 590010
Sponsors and Collaborators
Dr. Praveen B.H
Nathajirao G. Halgekar Institute of Dental Sciences & Research centre, Karnataka, India
Investigators
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Study Director: Praveen Bhoopathi, M.D.S Lecturer
Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
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Responsible Party: Dr. Praveen B.H, Principal investigator, Kamineni Institute of Dental Sciences
ClinicalTrials.gov Identifier: NCT02716558    
Other Study ID Numbers: AIMST university
First Posted: March 23, 2016    Key Record Dates
Last Update Posted: June 26, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes