Clinical trial NCT05962632: Efficacy and Cost-effectiveness of Different Caries Preventive Protocols
Official title: Efficacy and Cost-effectiveness of Different Caries Preventive Protocols in a High -Risk Group of Young Egyptian Adults: A Randomized Control Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: EARLY_PHASE1
Conditions: Caries Prevention
Keywords: prevention
Lead sponsor: Cairo University
Sponsor class: OTHER
Collaborators: name: Shofu Inc.
First posted: 2023-07-27
Enrollment: 44
Sex: ALL
Minimum age (years): 18
Maximum age (years): 25
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: 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

Eligibility 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

Primary outcomes:
measure: Caries increment
timeFrame: 12 moths
Secondary outcomes:
measure: Cost-Effectiveness
timeFrame: 12 months
Other outcomes:
Locations:
Study officials:
References:
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.
citation: 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.