Dental CariesNCT04436913
Evaluation of Preventive Regimens With Different Toothpastes vs Fluoride Varnish & Toothpaste in High Caries Patients
A study testing Himalaya complete care toothpaste, Signal toothpaste and Signal toothpaste and fluoride varnish in people with Dental Caries, run by Cairo University at 1 site in Egypt.
Trial summary
This study will be conducted in order to determine the prevention effect of caries preventive regimen using herbal toothpaste and regimen using fluoride toothpaste versus fluoride toothpaste and fluoride varnish on the caries risk of patients with high caries risk. Read more about this study
- Who is it for?
- Ages 15 to 50 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries
- What is being tested?
- Himalaya complete care toothpaste, Signal toothpaste and Signal toothpaste and fluoride varnish
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 54 participants
- Where
- 1 siteEgypt
- Study dates
- 16 Jan 2021to 31 Jan 2022
- Phase
- Interventional
- 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 15 to 50 years
- All sexes
- Healthy volunteers accepted
- Child, Adult
Who may be able to join
- Healthy patients with free medical history.
- Age range 15-50 years.
- Patients with high caries risk assessment due to increased cariogenic bacteria according to Cariogram.
- low fermentable carbohydrates diet patient
- Not under antibiotic therapy either at the time of the study or up to the last month before the start of the study.
Who cannot join
- Patients with a compromised medical history.
- Cariogenic diet patient.
- Extreme plaque accumulation and periodontal problems
- Participants with a history of allergy to any of the drugs or chemicals used in the study.
- Patients on any antibiotics during the past month
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of Prevention Potential of Preventive Regimens Containing Herbal-based and Fluoride-based Toothpastes Versus Fluoride Varnish and Fluoride Toothpaste Only in High Caries Risk Patients: A Randomized Clinical Trial
This study will be conducted in order to determine the prevention effect of caries preventive regimen using herbal toothpaste and regimen using fluoride toothpaste versus fluoride toothpaste and fluoride varnish on the caries risk of patients with high caries risk.
Read the detailed description
Dental caries is highly predominant worldwide. So, in addition to treating this caries, patients should be managed to avoid new caries. Preventive measures could be applied to the patients who are most expected to develop dental caries who are identified by caries risk assessment. Thus, effective caries risk assessment is essential to control new caries development.
Dental caries can be prevented by conducting appropriate measures; therefore, it is crucial to identify those who are most likely to have dental caries by caries risk assessment and giving them the essential preventive measures. Though some caries preventive measures have showed success in descriptive clinical trials, there is little information on their practicality with high caries risk groups in everyday usage.
Oral health is an essential part of general well being, people have used herbs in order to prevent dental diseases for centuries. In 2008 the Federal Council of Dentistry approved the use of medicinal plants for oral healthcare.
Medicinal plants can heal bacterial diseases as it is full of antimicrobial agents. They are becoming more popular than chemicals due to the side effects of synthetic antibiotics and the antibiotic resistance in microorganisms.
Studies propose that herbal extracts are highly effective against significant microorganism which cause dental caries like Streptococcus mutans. Herbal toothpaste decreases dental caries through combined effects of antibacterial agents, oral acid neutralisers and decreased plaque bacterial enzyme inhibitors present in the herbal toothpaste.
- Conditions
- Dental Caries
- Being tested
- Himalaya complete care toothpaste, Signal toothpaste, Signal toothpaste and fluoride varnish
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Himalaya complete care toothpasteOther
Herbal toothpaste as a part of a caries preventive regimen
Signal toothpasteOther
fluoride based toothpaste as a part of a caries preventive regimen
Signal toothpaste and fluoride varnishOther
application of fluoride varnish and using fluoride based toothpaste
| Study group | Role | What they receive |
|---|---|---|
| preventive regimen using Herbal toothpaste(Himalaya) | Experimental | The regimen includes herbal toothpaste containing "Neem , Miswak , Babool and Pomegranate" (Himalaya Complete Care). Receives: Other: Himalaya complete care toothpaste |
| preventive regimen using Fluoride based toothpaste (Signal). | Experimental | Participants will be using fluoride-based toothpaste (Signal), (1450 ppm sodium fluoride) Receives: Other: Signal toothpaste |
| Fluoride toothpaste and fluoride varnish | Active comparator | Participants will be using fluoride-based toothpaste (Signal), (1450 ppm sodium fluoride) and fluoride varnish Receives: Other: Signal toothpaste and fluoride varnish |
What is being measured
The primary outcome is the main question the study is designed to answer.
Caries risk assessment
Change in caries risk assessment by "cariogram software" as each patient data is collected in order to be inserted into the "Cariogram software" which in turn will evaluate this data and lead to a pie chart showing the chance of avoiding new caries as percentage.
This data includes caries experience, related diseases, diet content, fluoride program, salivary buffer capacity, saliva secretion rate, diet frequency, "Mutans streptococci" count, amount of plaque, and clinical examination.
Measured: Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jun 2020
- Study start16 Jan 2021
- Primary completion20 Sep 2021
- Study completion31 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Hoda Abdelmeguid Mohamed Fathy Ismail Sabry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04436913
- Sponsor's protocol ID
- Himalaya complete care
- Status last verified
- Jul 2022
- First submitted
- 15 Jun 2020
- Last updated
- 1 Aug 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 1 Aug 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Prevention Potential of Preventive Regimens Containing Herbal-based and Fluoride-based Toothpastes Versus Fluoride Varnish and Fluoride Toothpaste Only in High Caries Risk Patients: A Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04436913
- Acronym / sponsor ID
- Himalaya complete care
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 16 Jan 2021 (actual)
- Primary completion
- 20 Sep 2021 (actual)
- Study completion
- 31 Jan 2022 (actual)
- First posted
- 18 Jun 2020 (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.
This study will be conducted in order to determine the prevention effect of caries preventive regimen using herbal toothpaste and regimen using fluoride toothpaste versus fluoride toothpaste and fluoride varnish on the caries risk of patients with high caries risk.
Detailed description
Dental caries is highly predominant worldwide. So, in addition to treating this caries, patients should be managed to avoid new caries. Preventive measures could be applied to the patients who are most expected to develop dental caries who are identified by caries risk assessment. Thus, effective caries risk assessment is essential to control new caries development.
Dental caries can be prevented by conducting appropriate measures; therefore, it is crucial to identify those who are most likely to have dental caries by caries risk assessment and giving them the essential preventive measures. Though some caries preventive measures have showed success in descriptive clinical trials, there is little information on their practicality with high caries risk groups in everyday usage.
Oral health is an essential part of general well being, people have used herbs in order to prevent dental diseases for centuries. In 2008 the Federal Council of Dentistry approved the use of medicinal plants for oral healthcare.
Medicinal plants can heal bacterial diseases as it is full of antimicrobial agents. They are becoming more popular than chemicals due to the side effects of synthetic antibiotics and the antibiotic resistance in microorganisms.
Studies propose that herbal extracts are highly effective against significant microorganism which cause dental caries like Streptococcus mutans. Herbal toothpaste decreases dental caries through combined effects of antibacterial agents, oral acid neutralisers and decreased plaque bacterial enzyme inhibitors present in the herbal toothpaste.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| preventive regimen using Herbal toothpaste(Himalaya) | Experimental | Other: Himalaya complete care toothpasteThe regimen includes herbal toothpaste containing "Neem , Miswak , Babool and Pomegranate" (Himalaya Complete Care). |
| preventive regimen using Fluoride based toothpaste (Signal). | Experimental | Other: Signal toothpasteParticipants will be using fluoride-based toothpaste (Signal), (1450 ppm sodium fluoride) |
| Fluoride toothpaste and fluoride varnish | Active comparator | Other: Signal toothpaste and fluoride varnishParticipants will be using fluoride-based toothpaste (Signal), (1450 ppm sodium fluoride) and fluoride varnish |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Healthy patients with free medical history.
- Age range 15-50 years.
- Patients with high caries risk assessment due to increased cariogenic bacteria according to Cariogram.
- low fermentable carbohydrates diet patient
- Not under antibiotic therapy either at the time of the study or up to the last month before the start of the study.
Key exclusion criteria (5 listed)
- Patients with a compromised medical history.
- Cariogenic diet patient.
- Extreme plaque accumulation and periodontal problems
- Participants with a history of allergy to any of the drugs or chemicals used in the study.
- Patients on any antibiotics during the past month
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 |
|---|---|---|
| Himalaya complete care toothpasteHerbal toothpaste as a part of a caries preventive regimen | Other | preventive regimen using Herbal toothpaste(Himalaya) |
| Signal toothpastefluoride based toothpaste as a part of a caries preventive regimen | Other | preventive regimen using Fluoride based toothpaste (Signal). |
| Signal toothpaste and fluoride varnishapplication of fluoride varnish and using fluoride based toothpaste | Other | Fluoride toothpaste and fluoride varnish |
Primary outcome
Caries risk assessment
Time frame: Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.
Change in caries risk assessment by "cariogram software" as each patient data is collected in order to be inserted into the "Cariogram software" which in turn will evaluate this data and lead to a pie chart showing the chance of avoiding new caries as percentage. This data includes caries experience, related diseases, diet content, fluoride program, salivary buffer capacity, saliva secretion rate, diet frequency, "Mutans streptococci" count, amount of plaque, and clinical examination.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 1 Aug 2022.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Himalaya complete care toothpaste, Signal toothpaste and Signal toothpaste and fluoride varnish in people with Dental Caries, run by Cairo University at 1 site in Egypt.
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 5 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: finished, as of the sponsor's last update on 1 Aug 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
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.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Caries risk assessment (time frame: Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 1 Aug 2022.