Dental CariesNCT04446390
Preventive Regimens With Herbal and Fluoride Toothpaste on Remineralization in High Caries Patients With Initial Lesions
A study testing Himalaya complete care toothpaste and colgate cavity protection in people with Dental Caries, run by Cairo University at 2 sites in Egypt.
Trial summary
This study will be conducted to assess the effect of different preventive regimens using herbal toothpaste versus fluoride toothpaste on the management of remineralization and caries risk in high caries risk patients. 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 and colgate cavity protection
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 2 sitesEgypt
- Study dates
- 1 Jan 2021to 1 Mar 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 according to Cariogram.
- Patients with initial carious lesions at the facial surface of any teeth
- High plaque index
- Not under antibiotic therapy either at the time of the study or up to the last month before the start of the study
- The WSLs with LF measurements inside the range 14-20 were involved in this study.
- The lesions with scoring either 2 or 3 according to (ICDAS) scoring were included in the study
Who cannot join
- Patients with a compromised medical history.
- Patients with dentin caries
- Extreme plaque accumulation and periodontal problems
- Completely edentulous patients
- 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
Show all 9Show fewer
- The white spot lesion scoring is (<14) or (>20) according to diagnodent
- The white spot lesion scoring is other than 2, 3 according to ICDAS
- White spot lesions due to hypomineralization or fluorosis
Trial locations and contacts
2 sites in 1 country.
Egypt2 sites
Cairo University, Faculty of Oral and Dental Medicine
Cairo
Cairo University
Cairo
About this study
Official title: Evaluation of Remineralization Potential of Preventive Regimens Containing Herbal-based Compared to Fluoride-based Toothpastes in High Caries Risk Patients With Initial Carious Lesions: Randomized Clinical Trial
This study will be conducted to assess the effect of different preventive regimens using herbal toothpaste versus fluoride toothpaste on the management of remineralization and caries risk in high caries risk patients.
Read the detailed description
Dental caries is a major universal health problem with multiple etiological factors, so looking for economical and accurate plans for recognizing high-risk persons, and multiple risk factors to reduce the risk, in addition to caries management, using a caries risk assessment to detect the person who will develop caries, and provide them with suitable preventive and treatment regimens to disruption the disease procedure.
The treatment should evade invasive treatments and a large emphasis on prevention (using fluoride toothpaste, solutions, patient education, and so on), to achieve the aim of new dentistry (minimal intervention). The application of such a regimen to manage initial caries lesions allows the dentist to reverse initial lesions with the minimal victim of healthy dental tissues.
- Conditions
- Dental Caries
- Being tested
- Himalaya complete care toothpaste, colgate cavity protection
- 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
colgate cavity protectionOther
fluoride toothpaste as a part of a caries preventive regimen
| 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). Chew xylitol gum 2 pieces four times per day for 5 minutes after meals. Receives: Other: Himalaya complete care toothpaste |
| preventive regimen using Fluoride based toothpaste(colgate) | Active comparator | preventive regimen using Fluoride based toothpaste (colgate cavity protection). Participants will be using a fluoride-based toothpaste (colgate cavity protection), (1450 ppm Sodium monofluorophosphate). chew xylitol gum 2 pieces four times per day for 5 minutes after meals. Receives: Other: colgate cavity protection |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remineralization of initial carious lesions
changes in fluorescence of white spot lesions will be evaluated after reminerlization by using Diagnodent scoring (0-20): healthy teeth (0-14), initial carious lesions (14-20), dentinal caries (more than 20)
Measured: Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.
Secondary outcomes (1)
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.
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 posted24 Jun 2020
- Study start1 Jan 2021
- Primary completion1 Mar 2022 (estimated)
- Study completion1 Mar 2022 (estimated)
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
- 32 participants (actual)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yomna Hussin, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04446390
- Sponsor's protocol ID
- Himalaya herbal toothpaste
- Status last verified
- Jan 2022
- First submitted
- 22 Jun 2020
- Last updated
- 3 Feb 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 3 Feb 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Remineralization Potential of Preventive Regimens Containing Herbal-based Compared to Fluoride-based Toothpastes in High Caries Risk Patients With Initial Carious Lesions: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT04446390
- Acronym / sponsor ID
- Himalaya herbal toothpaste
- Conditions
- Dental Caries
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (actual)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jan 2021 (actual)
- Primary completion
- 1 Mar 2022 (estimated)
- Study completion
- 1 Mar 2022 (estimated)
- First posted
- 24 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 to assess the effect of different preventive regimens using herbal toothpaste versus fluoride toothpaste on the management of remineralization and caries risk in high caries risk patients.
Detailed description
Dental caries is a major universal health problem with multiple etiological factors, so looking for economical and accurate plans for recognizing high-risk persons, and multiple risk factors to reduce the risk, in addition to caries management, using a caries risk assessment to detect the person who will develop caries, and provide them with suitable preventive and treatment regimens to disruption the disease procedure.
The treatment should evade invasive treatments and a large emphasis on prevention (using fluoride toothpaste, solutions, patient education, and so on), to achieve the aim of new dentistry (minimal intervention). The application of such a regimen to manage initial caries lesions allows the dentist to reverse initial lesions with the minimal victim of healthy dental tissues.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| 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). Chew xylitol gum 2 pieces four times per day for 5 minutes after meals. |
| preventive regimen using Fluoride based toothpaste(colgate) | Active comparator | Other: colgate cavity protectionpreventive regimen using Fluoride based toothpaste (colgate cavity protection). Participants will be using a fluoride-based toothpaste (colgate cavity protection), (1450 ppm Sodium monofluorophosphate). chew xylitol gum 2 pieces four times per day for 5 minutes after meals. |
Who may qualify
- Ages
- 15 to 50 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult
Key inclusion criteria (8 listed)
Key exclusion criteria (9 listed)
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) |
| colgate cavity protectionfluoride toothpaste as a part of a caries preventive regimen | Other | preventive regimen using Fluoride based toothpaste(colgate) |
Primary outcome
Remineralization of initial carious lesions
Time frame: Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.
changes in fluorescence of white spot lesions will be evaluated after reminerlization by using Diagnodent scoring (0-20): healthy teeth (0-14), initial carious lesions (14-20), dentinal caries (more than 20)
1 secondary outcome
Caries risk assessment
Time frame: Outcomes will be evaluated at baseline, after 1 week, after 4 weeks and after 12 weeks.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Feb 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.
2 sites 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 and colgate cavity protection in people with Dental Caries, run by Cairo University at 2 sites 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 8 inclusion and 9 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 3 Feb 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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?
Results are not available in the source record.
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?
Remineralization of initial carious lesions (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 3 Feb 2022.