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Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Sealant (Part 2)

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT04793256
Collaborator
(none)
91
Enrollment
2
Arms
13
Anticipated Duration (Months)

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Device: Fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride).
  • Device: Resin based fissure sealant (3M Clinpro Sealant)
 N/A

Detailed Description

A Cochrane systematic reviews found low quality evidence supporting Current practice guidelines that recommend the use of Resin based fissure sealant over Fluoride varnish in prevent dental caries. However, they did not address the cost-effectiveness, A more recent systematic review and meta-analysis concluded that no statistical significance difference between Resin based fissure sealant and Fluoride varnish with a high-quality evidence in prevent dental caries.

This trial will measure cost effectiveness and clinical effectiveness for resin fissure sealant and fluoride varnish.

Study Design

Study Type:
Interventional
Anticipated Enrollment :
91 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
The study will be randomized, allocation-blinded, two-arm, parallel-group trial. The participants will be randomized on a 1: 1 allocation ratio to receive one of the following interventions: Resin-based fissure sealant FS. Fluoride varnish FVThe study will be randomized, allocation-blinded, two-arm, parallel-group trial.The participants will be randomized on a 1: 1 allocation ratio to receive one of the following interventions:Resin-based fissure sealant FS. Fluoride varnish FV
Masking:
None (Open Label)
Masking Description:
No one is blinded ( unfortunately) as fissure sealant will be obvious
Primary Purpose:
Prevention
Official Title:
Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Sealant in Newly Erupted Permanent Molars in Group of Egyptian Children: A Randomized Clinical Trial(Part 2).
Anticipated Study Start Date :
Apr 1, 2021
Anticipated Primary Completion Date :
May 1, 2022
Anticipated Study Completion Date :
May 1, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: intervention

Fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride). Group (1)

Device: Fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride).
5% sodium fluoride Varnish is a fluoride varnish which is applied to tooth surfaces
Other Names:
  • 5% sodium fluoride varnish 3M

    		•
    Active Comparator: comparator

    Resin based fissure sealant (3M Clinpro Sealant, light cure, low viscosity, fluoride release).group (2)

    Device: Resin based fissure sealant (3M Clinpro Sealant)
    teeth will be isolated with cotton rolls and saliva ejector than etching for pits and fissure sealant
    Other Names:
  • Resin based fissure sealant 3M

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Clinical-effectiveness (will be measured with DFS [Through study completion, an average of one year]

      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

    Secondary Outcome Measures

    1. Cost-effectiveness (will be measured with Incremental cost effective ratio ICER [through study completion, an average of one year]

      Cost-effectiveness (will be measured with Cost-effectiveness will be calculated based on the following measures:- Economic measures (continuous outcome, (money) will be measured with Calculate The total cost of each of FV and FS in every visit) . Clinical effectiveness (continuous outcome will be measured with DFS.

    Other Outcome Measures

    1. Time of application (continuous outcome, (minutes) will be measured with stopwatch. [Through application of interventions in treatment visit( baseline)]

      Time of application (continuous outcome, (minutes) will be measured with stopwatch.

    2. acceptability will be measured by questionnaire [through study completion, an average of one year]

      I will ask the parent and child if this trial is acceptable or not

    3. adverse effect will be measured by questionnaire [through study completion, an average of one year]

      Questionnaire for the parent (allergy, diarrhea or vomiting )

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    6 Years to 12 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • • Healthy children with no physical or mental disorders. Children with newly fully erupted permanent molars (PMs).
    Exclusion Criteria:

    • 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

    Contacts and Locations

    Locations

    No locations specified.

    Sponsors and Collaborators

    • Cairo University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Samah AbdelHafez Ahmed, principal investigator, Cairo University
    ClinicalTrials.gov Identifier:
    NCT04793256
    Other Study ID Numbers:
    • 115
    First Posted:
    Mar 11, 2021
    Last Update Posted:
    Mar 11, 2021
    Last Verified:
    Mar 1, 2021
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Additional relevant MeSH terms:
    Listerine
    Fluorides
    Sodium Fluoride
    Fluorides, Topical

    Study Results

    No Results Posted as of Mar 11, 2021