Efficacy and Cost-effectiveness of Different Caries Preventive Protocols

NCT05962632 | Unknown Early Phase 1 DMC

• 1 other identifier: E&C
• Study Type: interventional
• Target: 44
• Locations: 0 countries
• Sites: N/A

Brief Summary

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

Conditions

Caries Prevention

Keywords

prevention

Outcome Measures

Primary Outcomes (1)

• Caries increment

  number of carious tooth surfaces will be calculated ( DMFS score)will be monitored and recorded separately.

  12 moths

Secondary Outcomes (1)

• Cost-Effectiveness

  12 months

Study Arms (4)

Clinical-based preventive platform

EXPERIMENTAL

applying of Fluoride varnish every 3 months

Drug: Fluoride based varnish (Dentkist Charm Fill Varnish )

Home-based preventive platform

EXPERIMENTAL

topical remineralizing agent

Drug: pro care gel remineralizing agent

E health platform

EXPERIMENTAL

Mobile application

Device: Mobile application

Basic preventive measures

ACTIVE COMPARATOR

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

Interventions

Fluoride based varnish (Dentkist Charm Fill Varnish ) DRUG

topical Fluoride varnish administrated professionally every 3 months in the clinic

Clinical-based preventive platform

pro care gel remineralizing agent DRUG

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

Home-based preventive platform

Mobile application DEVICE

examine the impact of Mobile application on caries prevention

E health platform

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

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

Basic preventive measures

Eligibility Criteria

• Age: 18 Years - 25 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• High caries risk patients.
• years.
• Males or females.
• Participants approving to enrol in this study.
• Participants not enrolled in any other study.

You may not qualify if:

• 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

Sponsors & Collaborators

• Roya mohamed Hamad Elmaghrbi: lead
• Shofu Inc.: collaborator

Related Publications (6)

• 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.

  PMID: 28682498 BACKGROUND

• 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.

  PMID: 30632864 BACKGROUND

• 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.

  PMID: 30517071 BACKGROUND

• 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.

  PMID: 34024883 BACKGROUND

• 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.

  PMID: 37103326 BACKGROUND

• 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.

  PMID: 31349691 BACKGROUND

Central Study Contacts

roya mohamed hamad, master

CONTACT

01030435140; roya.hamad@dentistry.cu.edu.eg

roya mohamed hamad, master

CONTACT

01030435140; rowamohamed2014@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: assessors will unaware of the treatment assigned to the patients therefore the assessors will not be included in the pre clinical assessment.
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: doctor

Study Record Dates

• First Submitted: July 7, 2023
• First Posted: July 27, 2023
• Study Start: September 1, 2023
• Primary Completion: September 1, 2024
• Study Completion: December 1, 2024
• Last Updated: July 27, 2023

Record last verified: 2023-07