Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Sealant
1 other identifier
interventional
91
1 country
1
Brief Summary
The aim of the present study is determine the cost-effectiveness, clinical-effectiveness, acceptability and adverse effect of resin sealants versus the fluoride varnish for the prevention of dental caries on newly erupted permanent molars.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Jul 2021
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
First Submitted
Initial submission to the registry
October 13, 2020
CompletedFirst Posted
Study publicly available on registry
October 27, 2020
CompletedStudy Start
First participant enrolled
July 10, 2021
CompletedPrimary Completion
Last participant's last visit for primary outcome
August 1, 2022
CompletedStudy Completion
Last participant's last visit for all outcomes
September 1, 2022
CompletedAugust 2, 2021
January 1, 2021
1.1 years
October 13, 2020
July 27, 2021
Conditions
Outcome Measures
Primary Outcomes (1)
Clinical-effectiveness (will be measured with DFS
Clinical-effectiveness (will be measured by DFS) Clinical effectiveness (continuous outcome will be measured with DFS D Decayed in permanent molar Filling in permanent molar S Surface
Through study completion, an average of one year
Secondary Outcomes (4)
Cost-effectiveness (will be measured with Incremental cost effective ratio ICER
through study completion, an average of one year
Time of application (continuous outcome, (minutes) will be measured with stopwatch.
Through application of interventions in treatment visit( baseline)
acceptability will be measured by questionnaire
through study completion, an average of one year
adverse effect will be measured by questionnaire
through study completion, an average of one year
Study Arms (2)
(intervention)
EXPERIMENTALFluoride varnish (3M Clinpro White Varnish 5% sodium fluoride). Group (1)
comparator
ACTIVE COMPARATORResin based fissure sealant (3M Clinpro Sealant, light cure, low viscosity, fluoride release).group (2)
Interventions
5% Sodium Fluoride Varnish is a fluoride varnish which is applied to tooth surfaces for sealing dentinal tubules and treatment of hypersensitive teeth. The varnish is applied in a thin layer over the tooth with an applicator brush, and moisture from saliva cures the varnish for adhesion to the tooth surface.
teeth will be isolated with coton rolls and saliva ejector then etching for pits and fissure then tooth will be washed then apply resin based fissure sealant on occlusal surface. resin fissure sealant is a more sensitive for saliva.
Eligibility Criteria
You may qualify if:
- Healthy children with no physical or mental disorders. Children with newly fully erupted permanent molars (PMs).
You may not qualify if:
- Teeth will be excluded from the study if they had any of the following:
- Dental caries in dentine
- History of pain or swelling. Parents refused their children participate in the trial
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Cairo Universitylead
Study Sites (1)
Oral and dental medicine Cairo university
Giza, Egypt
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- NONE
- Masking Details
- No one is blinded ( unfortunately) as fissure sealant will be obvious
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- principal investigator
Study Record Dates
First Submitted
October 13, 2020
First Posted
October 27, 2020
Study Start
July 10, 2021
Primary Completion
August 1, 2022
Study Completion
September 1, 2022
Last Updated
August 2, 2021
Record last verified: 2021-01