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

March 9, 2021 updated by: Samah AbdelHafez Ahmed, Cairo University

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).

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.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Anticipated)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

6 years to 12 years (CHILD)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: PREVENTION
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: NONE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Clinical-effectiveness (will be measured with DFS
Time Frame: 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
Through study completion, an average of one year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Cost-effectiveness (will be measured with Incremental cost effective ratio ICER
Time Frame: 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.
through study completion, an average of one year

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
Time of application (continuous outcome, (minutes) will be measured with stopwatch.
Time Frame: Through application of interventions in treatment visit( baseline)
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
Time Frame: through study completion, an average of one year
I will ask the parent and child if this trial is acceptable or not
through study completion, an average of one year
adverse effect will be measured by questionnaire
Time Frame: through study completion, an average of one year
Questionnaire for the parent (allergy, diarrhea or vomiting )
through study completion, an average of one year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Cairo University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

April 1, 2021

Primary Completion (ANTICIPATED)

May 1, 2022

Study Completion (ANTICIPATED)

May 1, 2022

Study Registration Dates

First Submitted

March 9, 2021

First Submitted That Met QC Criteria

March 9, 2021

First Posted (ACTUAL)

March 11, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 11, 2021

Last Update Submitted That Met QC Criteria

March 9, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 115

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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