Efficacy and Cost-effectiveness of Different Caries Preventive Protocols

Early Phase 1

Not yet recruiting

• Conditions: Caries Prevention
• Interventions: 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

• Registration Number: NCT05962632
• Lead Sponsor: Roya mohamed Hamad Elmaghrbi

Brief Summary

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

Detailed Description

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

Study Timeline

• Status Verified: 2023-07
• Study First Submitted: 2023-07-07
• Study First Submitted QC: 2023-07-25
• Last Update Submitted: 2023-07-25
• Study First Posted: 2023-07-27
• Last Update Posted: 2023-07-27
• Study Start: 2023-09-01
• Primary Completion: 2024-09-01
• Study Completion: 2024-12-01

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 44

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Clinical-based preventive platform	Fluoride based varnish (Dentkist Charm Fill Varnish )	applying of Fluoride varnish every 3 months
Home-based preventive platform	pro care gel remineralizing agent	topical remineralizing agent
E health platform	Mobile application	Mobile application
Basic preventive measures	tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning,fluoride rinse OTC	tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning, fluoride rinse OTC

Primary Outcome Measures

Name	Time	Method
Caries increment	12 moths	number of carious tooth surfaces will be calculated ( DMFS score)will be monitored and recorded separately.

Secondary Outcome Measures

Name	Time	Method
Cost-Effectiveness	12 months	the cost effective will be calculated by the statistician (Net costs/Change in health outcome).