Efficacy and Cost-effectiveness of Different Caries Preventive Protocols
Study Details
Study Description
Brief Summary
To compare the caries preventive efficacy of clinical-based, home based or E-based oral health interventions and their cost effectiveness.
| Condition or Disease | Intervention/Treatment | Phase |
|---|---|---|
|
Early Phase 1 |
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 Design
Arms and Interventions
| 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 )
|
Outcome Measures
Primary Outcome Measures
- Caries increment [12 moths]
number of carious tooth surfaces will be calculated ( DMFS score)will be monitored and recorded separately.
Secondary Outcome Measures
- Cost-Effectiveness [12 months]
the cost effective will be calculated by the statistician (Net costs/Change in health outcome).
Eligibility Criteria
Criteria
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
Contacts and Locations
Locations
No locations specified.Sponsors and Collaborators
- Roya mohamed Hamad Elmaghrbi
- Shofu Inc.
Investigators
None specified.Study Documents (Full-Text)
None provided.More Information
Publications
- Achilleos E, Rahiotis C, Kavvadia K, Vougiouklakis G. Clinical Evaluation of Two Different Prevention Programs in Adults Depending on Their Caries Risk Profile: One-year Results. Oper Dent. 2019 Mar/Apr;44(2):127-137. doi: 10.2341/17-164-C. Epub 2018 Dec 5.
- El Tantawi M, Bakhurji E, Al-Ansari A, AlSubaie A, Al Subaie HA, AlAli A. Indicators of adolescents' preference to receive oral health information using social media. Acta Odontol Scand. 2019 Apr;77(3):213-218. doi: 10.1080/00016357.2018.1536803. Epub 2019 Jan 11.
- Fraihat N, Madae'en S, Bencze Z, Herczeg A, Varga O. Clinical Effectiveness and Cost-Effectiveness of Oral-Health Promotion in Dental Caries Prevention among Children: Systematic Review and Meta-Analysis. Int J Environ Res Public Health. 2019 Jul 25;16(15):2668. doi: 10.3390/ijerph16152668.
- Imazato S, Nakatsuka T, Kitagawa H, Sasaki JI, Yamaguchi S, Ito S, Takeuchi H, Nomura R, Nakano K. Multiple-Ion Releasing Bioactive Surface Pre-Reacted Glass-Ionomer (S-PRG) Filler: Innovative Technology for Dental Treatment and Care. J Funct Biomater. 2023 Apr 21;14(4):236. doi: 10.3390/jfb14040236.
- Schwendicke F, Splieth CH, Thomson WM, Reda S, Stolpe M, Foster Page L. Cost-effectiveness of caries-preventive fluoride varnish applications in clinic settings among patients of low, moderate and high risk. Community Dent Oral Epidemiol. 2018 Feb;46(1):8-16. doi: 10.1111/cdoe.12320. Epub 2017 Jul 6.
- Shinkai K, Yoshii D. Effect of the S-PRG filler content in the multi-ion releasing paste on the acid resistance of the enamel surface after polishing with the paste. Dent Mater J. 2021 Sep 30;40(5):1136-1141. doi: 10.4012/dmj.2020-303. Epub 2021 May 21.
- E&C