Clinical and Cost-effectiveness of Fluoride Varnish Versus Resin Based Sealant

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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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)

Conditions
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Cost Effectiveness

Intervention / Treatment
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* Device: fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride )
* Device: Resin based fissure sealant (3M Clinpro sealant )


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 6 Years
Maximum Age: 12 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional 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 FV
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: (intervention)<br>Fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride). Group (1) | Device: fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride )<br>* 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.<br>* Other names: 5% Sodium Fluoride Varnish 3M;|
| Active Comparator: comparator<br>Resin based fissure sealant (3M Clinpro Sealant, light cure, low viscosity, fluoride release).group (2) | Device: Resin based fissure sealant (3M Clinpro sealant )<br>* 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.<br>* Other names: resin fissure sealant 3M;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-effectiveness (will be measured with Incremental cost effective ratio ICER | 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 of application (continuous outcome, (minutes) will be measured with stopwatch. | Through application of interventions in treatment visit( baseline) | 
| acceptability will be measured by questionnaire | 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 | Questionnaire for the parent (allergy, diarrhea or vomiting ) | through study completion, an average of one year |