Efficacy and Cost-effectiveness of Different Caries Preventive Protocols

Study Overview
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Brief Summary
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To compare the caries preventive efficacy of clinical-based, home based or E-based oral health interventions and their cost effectiveness.

Detailed Description
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Caries risk assessment and preventive measures have been performed over years with different perspectives without attention to budgeting and economic value and the preventive protocols remain uncertain for adults. caries prevention, for example using fluoride varnish, has been found only limitedly cost-effective in clinic settings, which is why alternative strategies involving home-based interventions are sought .Electronic health (E-health) interventions for patient motivation and enhancing of patient adherence, for example via reminders about the reinforcement of hygiene measures and dietary counseling as well as recall visits were found to be of value This randomized controlled clinical study aims to compare the caries preventive efficacy of clinical-based, home based or E-based oral health interventions and their cost effectiveness

Official Title
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Efficacy and Cost-effectiveness of Different Caries Preventive Protocols in a High -Risk Group of Young Egyptian Adults: A Randomized Control Trial

Conditions
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Caries Prevention

Intervention / Treatment
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* Drug: Fluoride based varnish (Dentkist Charm Fill Varnish )
* Drug: pro care gel remineralizing agent
* Device: Mobile application
* Combination Product: tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning,fluoride rinse OTC


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: High caries risk patients. 18-25years. Males or females. Participants approving to enrol in this study. Participants not enrolled in any other study. Exclusion Criteria: low or moderate caries risk Participants with systematic conditions. Patients younger than 18 years. Evidence of parafunctional habits. with developmental dental anomalies. undergoing or will start orthodontic treatment. with removable prosthesis

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 25 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
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Clinical-based preventive platform<br>applying of Fluoride varnish every 3 months | Drug: Fluoride based varnish (Dentkist Charm Fill Varnish )<br>* topical Fluoride varnish administrated professionally every 3 months in the clinic<br>|
| Experimental: Home-based preventive platform<br>topical remineralizing agent | Drug: pro care gel remineralizing agent<br>* topical remineralizing agent (Surface Pre-Reacted Glass ionomer filler SPRG based)SHOFU company<br>|
| Experimental: E health platform<br>Mobile application | Device: Mobile application<br>* examine the impact of Mobile application on caries prevention<br>|
| Active Comparator: Basic preventive measures<br>tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning, fluoride rinse OTC | Combination Product: tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning,fluoride rinse OTC<br>* interdental cleaning(dental floss),fluoride rinse OTC (B-FRESH MOUTH WASH )<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Caries increment | number of carious tooth surfaces will be calculated ( DMFS score)will be monitored and recorded separately. | 12 moths | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Cost-Effectiveness | the cost effective will be calculated by the statistician (Net costs/Change in health outcome). | 12 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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prevention