Efficacy and Cost-effectiveness of Different Caries Preventive Protocols

Caries Prevention Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05962632
• Other study ID #: E&C
• Status: Not yet recruiting
• Phase: Early Phase 1
• Start date: September 1, 2023
• Est. completion date: December 1, 2024

Study information

• Verified date: July 2023
• Source: Cairo University
• Contact: roya mohamed hamad, master
• Phone: 01030435140
• Email: roya.hamad[@]dentistry.cu.edu.eg
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 44
• Est. completion date: December 1, 2024
• Est. primary completion date: September 1, 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 25 Years

Eligibility

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

Related Conditions & MeSH terms

• Caries Prevention

Intervention

Drug:
• Fluoride based varnish (Dentkist Charm Fill Varnish )
topical Fluoride varnish administrated professionally every 3 months in the clinic
• pro care gel remineralizing agent
topical remineralizing agent (Surface Pre-Reacted Glass ionomer filler SPRG based)SHOFU company

Device:
• Mobile application
examine the impact of Mobile application on caries prevention

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 )

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
Roya mohamed Hamad Elmaghrbi	Shofu Inc.

References & Publications (6)

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. — View 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. — View 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. — View 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. — View 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. — View 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Caries increment	number of carious tooth surfaces will be calculated ( DMFS score)will be monitored and recorded separately.	12 moths
Secondary	Cost-Effectiveness	the cost effective will be calculated by the statistician (Net costs/Change in health outcome).	12 months