Cost Effectiveness
Conditions
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.
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.
Interventions
DEVICEfluoride varnish (3M Clinpro White Varnish 5% sodium fluoride )
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.
DEVICEResin based fissure sealant (3M Clinpro sealant )
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.
Sponsors
Cairo University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE
Masking description
No one is blinded ( unfortunately) as fissure sealant will be obvious
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 FV
Eligibility
Sex/Gender
ALL
Age
6 Years to 12 Years
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| adverse effect will be measured by questionnaire | through study completion, an average of one year | Questionnaire for the parent (allergy, diarrhea or vomiting ) |
| 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. |
| 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. |
| 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 |
Countries
Egypt
Contacts
Primary ContactEsraa Mohamed Zaghloul, B.Sc
Backup ContactPassant Nagi, PHD
Outcome results
None listed