Efficacy and Cost-effectiveness of Different Caries Preventive Protocols

July 25, 2023 updated by: Roya mohamed Hamad Elmaghrbi

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

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

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Estimated)

44

Phase

  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Caries increment
Time Frame: 12 moths
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
Time Frame: 12 months
the cost effective will be calculated by the statistician (Net costs/Change in health outcome).
12 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Roya mohamed Hamad Elmaghrbi

Collaborators

Shofu Inc.

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

September 1, 2023

Primary Completion (Estimated)

September 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

July 7, 2023

First Submitted That Met QC Criteria

July 25, 2023

First Posted (Actual)

July 27, 2023

Study Record Updates

Last Update Posted (Actual)

July 27, 2023

Last Update Submitted That Met QC Criteria

July 25, 2023

Last Verified

July 1, 2023

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • E&C

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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