Efficacy and Cost-effectiveness of Different Caries Preventive Protocols

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

EARLY_PHASE1

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-09-01

Study Completion Date

2024-12-01

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.

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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

Conditions

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Caries Prevention

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

SINGLE

Outcome Assessors

assessors will unaware of the treatment assigned to the patients therefore the assessors will not be included in the pre clinical assessment.

Study Groups

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Clinical-based preventive platform

applying of Fluoride varnish every 3 months

Group Type EXPERIMENTAL

Fluoride based varnish (Dentkist Charm Fill Varnish )

Intervention Type DRUG

topical Fluoride varnish administrated professionally every 3 months in the clinic

Home-based preventive platform

topical remineralizing agent

Group Type EXPERIMENTAL

pro care gel remineralizing agent

Intervention Type DRUG

topical remineralizing agent (Surface Pre-Reacted Glass ionomer filler SPRG based)SHOFU company

E health platform

Mobile application

Group Type EXPERIMENTAL

Mobile application

Intervention Type DEVICE

examine the impact of Mobile application on caries prevention

Basic preventive measures

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

Group Type ACTIVE_COMPARATOR

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

Intervention Type COMBINATION_PRODUCT

interdental cleaning(dental floss),fluoride rinse OTC (B-FRESH MOUTH WASH )

Interventions

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Fluoride based varnish (Dentkist Charm Fill Varnish )

topical Fluoride varnish administrated professionally every 3 months in the clinic

Intervention Type DRUG

pro care gel remineralizing agent

topical remineralizing agent (Surface Pre-Reacted Glass ionomer filler SPRG based)SHOFU company

Intervention Type DRUG

Mobile application

examine the impact of Mobile application on caries prevention

Intervention Type DEVICE

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

interdental cleaning(dental floss),fluoride rinse OTC (B-FRESH MOUTH WASH )

Intervention Type COMBINATION_PRODUCT

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

Minimum Eligible Age

18 Years

Maximum Eligible Age

25 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes