Efficacy and Cost-effectiveness of Different Caries Preventive Protocols

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

Status

UNKNOWN

Phases

Early Phase 1

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05962632

Enrollment

Registered

2023-07-27

Start date

2023-09-01

Completion date

2024-12-01

Last updated

2023-07-27

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Caries Prevention

Keywords

prevention

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

Interventions

DRUGFluoride based varnish (Dentkist Charm Fill Varnish )

topical Fluoride varnish administrated professionally every 3 months in the clinic

DRUGpro care gel remineralizing agent

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

DEVICEMobile application

examine the impact of Mobile application on caries prevention

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

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

PREVENTION

Masking

SINGLE (Outcomes Assessor)

Masking description

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

Eligibility

Sex/Gender

ALL

Age

18 Years to 25 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

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

Secondary

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

Contacts

Primary Contactroya mohamed hamad, master

roya.hamad@dentistry.cu.edu.eg01030435140

Backup Contactroya mohamed hamad, master

rowamohamed2014@gmail.com01030435140

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026