Caries PreventionEarly Phase 1NCT05962632
Efficacy and Cost-effectiveness of Different Caries Preventive Protocols
A Early Phase 1 study testing Fluoride based varnish (Dentkist Charm Fill Varnish ), pro care gel remineralizing agent and Mobile application in people with Caries Prevention, run by Roya mohamed Hamad Elmaghrbi.
Trial summary
To compare the caries preventive efficacy of clinical-based, home based or E-based oral health interventions and their cost effectiveness. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries Prevention
- What is being tested?
- Fluoride based varnish (Dentkist Charm Fill Varnish ), pro care gel remineralizing agent and Mobile application
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- No sites listed yet
- Study dates
- 1 Sep 2023to 1 Dec 2024
- Phase
- Early Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- High caries risk patients.
- 18-25years.
- Males or females.
- Participants approving to enrol in this study.
- Participants not enrolled in any other study.
Who cannot join
- 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
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Efficacy and Cost-effectiveness of Different Caries Preventive Protocols in a High -Risk Group of Young Egyptian Adults: A Randomized Control Trial
To compare the caries preventive efficacy of clinical-based, home based or E-based oral health interventions and their cost effectiveness.
Read the 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
- Conditions
- Caries Prevention
- Being tested
- Fluoride based varnish (Dentkist Charm Fill Varnish ), pro care gel remineralizing agent, Mobile application, tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning,fluoride rinse OTC
- Keywords
- prevention
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Fluoride based varnish (Dentkist Charm Fill Varnish )Drug
topical Fluoride varnish administrated professionally every 3 months in the clinic
pro care gel remineralizing agentDrug
topical remineralizing agent (Surface Pre-Reacted Glass ionomer filler SPRG based)SHOFU company
Mobile applicationDevice
examine the impact of Mobile application on caries prevention
tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning,fluoride rinse OTCCombination product
interdental cleaning(dental floss),fluoride rinse OTC (B-FRESH MOUTH WASH )
| Study group | Role | What they receive |
|---|---|---|
| Clinical-based preventive platform | Experimental | applying of Fluoride varnish every 3 months Receives: Drug: Fluoride based varnish (Dentkist Charm Fill Varnish ) |
| Home-based preventive platform | Experimental | topical remineralizing agent Receives: Drug: pro care gel remineralizing agent |
| E health platform | Experimental | Mobile application Receives: Device: Mobile application |
| Basic preventive measures | Active comparator | tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning, fluoride rinse OTC Receives: Combination Product: tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning,fluoride rinse OTC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries increment
number of carious tooth surfaces will be calculated ( DMFS score)will be monitored and recorded separately.
Measured: 12 moths
Secondary outcomes (1)
Cost-Effectiveness
the cost effective will be calculated by the statistician (Net costs/Change in health outcome).
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2023
- Study start1 Sep 2023 (estimated)
- Primary completion1 Sep 2024 (estimated)
- Study completion1 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (6)Papers the sponsor has linked to this study.
- Other trials for Caries PreventionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 44 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Roya mohamed Hamad Elmaghrbi
- Sponsor type
- University, hospital or other
- Collaborators
- Shofu Inc.
- Responsible party
- Sponsor-investigator, Roya mohamed Hamad Elmaghrbi, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05962632
- Sponsor's protocol ID
- E&C
- Status last verified
- Jul 2023
- First submitted
- 7 Jul 2023
- Last updated
- 27 Jul 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
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.
PubMed 28682498El 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.
PubMed 30632864Achilleos 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.
PubMed 30517071Shinkai 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.
PubMed 34024883Imazato 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.
PubMed 37103326Fraihat 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.
PubMed 31349691
Study at a glance
From the registry record, last updated by the sponsor on 27 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Cost-effectiveness of Different Caries Preventive Protocols in a High -Risk Group of Young Egyptian Adults: A Randomized Control Trial
- ClinicalTrials.gov ID
- NCT05962632
- Acronym / sponsor ID
- E&C
- Conditions
- Caries Prevention
- Keywords
- prevention
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 44 participants (estimated)
- Lead sponsor
- Roya mohamed Hamad ElmaghrbiUniversity, hospital or other
- Collaborators
- Shofu Inc.
- Study start
- 1 Sep 2023 (estimated)
- Primary completion
- 1 Sep 2024 (estimated)
- Study completion
- 1 Dec 2024 (estimated)
- First posted
- 27 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Clinical-based preventive platform | Experimental | Drug: Fluoride based varnish (Dentkist Charm Fill Varnish )applying of Fluoride varnish every 3 months |
| Home-based preventive platform | Experimental | Drug: pro care gel remineralizing agenttopical remineralizing agent |
| E health platform | Experimental | Device: Mobile applicationMobile application |
| Basic preventive measures | Active comparator | Combination Product: tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning,fluoride rinse OTCtooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning, fluoride rinse OTC |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- High caries risk patients.
- 18-25years.
- Males or females.
- Participants approving to enrol in this study.
- Participants not enrolled in any other study.
Key exclusion criteria (7 listed)
- low or moderate caries risk
- Participants with systematic conditions.
- Patients younger than 18 years.
- Evidence of parafunctional habits.
- with developmental dental anomalies.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Fluoride based varnish (Dentkist Charm Fill Varnish )topical Fluoride varnish administrated professionally every 3 months in the clinic | Drug | Clinical-based preventive platform |
| pro care gel remineralizing agenttopical remineralizing agent (Surface Pre-Reacted Glass ionomer filler SPRG based)SHOFU company | Drug | Home-based preventive platform |
| Mobile applicationexamine the impact of Mobile application on caries prevention | Device | E health platform |
| tooth brushing/fluoridated toothpaste over the counter 1450 ppm, interdental cleaning,fluoride rinse OTCinterdental cleaning(dental floss),fluoride rinse OTC (B-FRESH MOUTH WASH ) | Combination product | Basic preventive measures |
Primary outcome
Caries increment
Time frame: 12 moths
number of carious tooth surfaces will be calculated ( DMFS score)will be monitored and recorded separately.
1 secondary outcome
Cost-Effectiveness
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jul 2023.
- Background: PubMed 28682498Schwendicke 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.
- Background: PubMed 30632864El 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.
- Background: PubMed 30517071Achilleos 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.
- Background: PubMed 34024883Shinkai 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.
- Background: PubMed 37103326Imazato 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.
- Background: PubMed 31349691Fraihat 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Fluoride based varnish (Dentkist Charm Fill Varnish ), pro care gel remineralizing agent and Mobile application in people with Caries Prevention, run by Roya mohamed Hamad Elmaghrbi.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 27 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact roya mohamed hamad, master (01030435140, roya.hamad@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries increment (time frame: 12 moths). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05962632, which also lists 6 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Jul 2023.