- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04603573
Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Sealant
Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Fissure Sealant in Newly Erupted Permanent Molars in Group of Egyptian Children : A Randomized Clinical Trial ( Part 1)
Study Overview
Status
Conditions
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
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Contact
- Name: Esraa Mohamed Zaghloul, B.Sc
- Phone Number: 0201146030022
- Email: Esraa.Mohamed@dentistry.cu.edu.eg
Study Locations
-
-
-
Giza, Egypt
- Recruiting
- oral and dental medicine Cairo university
-
Contact:
- Esraa Mohamed Zaghloul
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
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
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: (intervention)
Fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride).
Group (1)
|
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.
Other Names:
|
Active Comparator: comparator
Resin based fissure sealant (3M Clinpro Sealant, light cure, low viscosity, fluoride release).group
(2)
|
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.
Other Names:
|
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
|
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
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 112
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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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