Efficacy and Cost-effectiveness of Different Caries Preventive Protocols

Roya mohamed Hamad Elmaghrbi

Status and phase: Not yet enrolling; Early Phase 1

Conditions: Caries Prevention

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

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT05962632

E&C

Details and patient eligibility

About

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

Full 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

Enrollment: 44 estimated patients

Sex: All

Ages: 18 to 25 years old

Volunteers: Accepts Healthy Volunteers

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

Trial design

Primary purpose: Prevention

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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44 participants in 4 patient groups

Clinical-based preventive platform

Experimental group

Description:

applying of Fluoride varnish every 3 months

Treatment:

Drug: Fluoride based varnish (Dentkist Charm Fill Varnish )

Home-based preventive platform

Experimental group

Description:

topical remineralizing agent

Treatment:

Drug: pro care gel remineralizing agent

E health platform

Experimental group

Description:

Mobile application

Treatment:

Device: Mobile application

Basic preventive measures

Active Comparator group

Description:

tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning, fluoride rinse OTC

Treatment:

Combination Product: tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning,fluoride rinse OTC