A Clinical Trial to Assess the Retention and Caries Preventive Effects of Moisture Tolerant Resin Sealant and ART Sealants
1 other identifier
interventional
93
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_3
Started Feb 2016
Shorter than P25 for phase_3
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 1, 2016
CompletedFirst Submitted
Initial submission to the registry
March 7, 2016
CompletedFirst Posted
Study publicly available on registry
March 23, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
March 1, 2017
CompletedStudy Completion
Last participant's last visit for all outcomes
April 1, 2017
CompletedJune 26, 2018
June 1, 2018
1.1 years
March 7, 2016
June 23, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Retention of the sealants
The retention of the sealants will be assessed by using the MODIFIED SIMENSONS CRITERIA
Baseline to 1 year
Study Arms (2)
Moisture tolerant resin sealant
EXPERIMENTALMoisture resistant sealant (wet bond sealant)
ART sealant
ACTIVE COMPARATORGlass inomer based sealant
Interventions
application of the ART sealant using high viscosity glass inomer cements.
application of the moisture tolerant sealant according to the manufacturers instructions.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Maratha Mandal's Nathajirao G. Halgekar Institute of Dental Sciences & Research Centre.
Belagavi, Karnataka, 590010, India
Related Publications (1)
Haricharan PB, Barad N, Patil CR, Voruganti S, Mudrakola DP, Turagam N. Dawn of a New Age Fissure Sealant? A Study Evaluating the Clinical Performance of Embrace WetBond and ART Sealants: Results from a Randomized Controlled Clinical Trial. Eur J Dent. 2019 Oct;13(4):503-509. doi: 10.1055/s-0039-1696894. Epub 2019 Dec 31.
PMID: 31891967DERIVED
Study Officials
- STUDY DIRECTOR
Praveen Bhoopathi, M.D.S
Lecturer
Study Design
- Study Type
- interventional
- Phase
- phase 3
- Allocation
- RANDOMIZED
- Masking
- DOUBLE
- Who Masked
- INVESTIGATOR, OUTCOMES ASSESSOR
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR INVESTIGATOR
- PI Title
- Principal investigator
Study Record Dates
First Submitted
March 7, 2016
First Posted
March 23, 2016
Study Start
February 1, 2016
Primary Completion
March 1, 2017
Study Completion
April 1, 2017
Last Updated
June 26, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will share