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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| (intervention) | Experimental | Fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride). Group (1) |
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| comparator | Active Comparator | Resin based fissure sealant (3M Clinpro Sealant, light cure, low viscosity, fluoride release).group (2) |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| fluoride varnish (3M Clinpro White Varnish 5% sodium fluoride ) | Device | 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. |
| 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 |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
Teeth will be excluded from the study if they had any of the following:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Esraa Mohamed Zaghloul, B.Sc | Contact | 0201146030022 | Esraa.Mohamed@dentistry.cu.edu.eg | |
| Passant Nagi, PHD | Contact | 0201280557107 | Passant.Nagi@dentistry.cu.edu.eg |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Oral and dental medicine Cairo university | Recruiting | Giza | Egypt |
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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:
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No one is blinded ( unfortunately) as fissure sealant will be obvious
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| Resin based fissure sealant (3M Clinpro sealant ) | Device | 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. |
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| 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 |