CariesNCT05109299
Antibacterial Effect of Miswak Toothpaste Compared to Fluoride Toothpaste
A study testing Miswak toothpaste and Fluoride toothpaste in people with Caries, run by Cairo University at 1 site in Egypt.
Trial summary
Meswak is scientifically formulated herbal toothpaste with pure extract of the Miswak plant 'Salvadore Persica', the famous 'Toothbrush Tree' used for centuries. The astringent and anti-bacterial properties of Meswak helps reduce tooth decay , fight plaque and prevent gum diseases. Read more about this study
- Who is it for?
- Ages 18 to 25 years
- Conditions the study is for
- Caries
- What is being tested?
- Miswak toothpaste and Fluoride toothpaste
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 32 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Dec 2021to 30 Apr 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 18 to 25 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- High caries risk patients.
- At least one carious tooth according to CAT caries risk assessment model.
- Patient compliance
Who cannot join
- Participant in another trial.
- Using another antimicrobial agents since one month of sampling.
- Systemic diseases or concomitant medication affecting salivary flow.
- Parafunctional habits.
- Pregnancy.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dentistry, Cairo University
Cairo, El Manial, 11553
Omar O Shaalan, Phd, 00201122665661, omar.shaalan@dentistry.cu.edu.eg
About this study
Official title: Antibacterial Effect of Miswak Toothpaste Compared to Fluoride Toothpaste in High Caries Risk Patients: Randomized Clinical Trial
Meswak is scientifically formulated herbal toothpaste with pure extract of the Miswak plant 'Salvadore Persica', the famous 'Toothbrush Tree' used for centuries. The astringent and anti-bacterial properties of Meswak helps reduce tooth decay , fight plaque and prevent gum diseases. Miswak Herb is a rare, potent, priceless, wonder herb that delivers incredible Dental Care benefits.
Read the detailed description
This study is a randomized clinical trial, with parallel study design, 1:1 allocation ratio and superiority framework. The aim of the current trial is to evaluate antibacterial effect miswak toothpaste compared to fluoride toothpaste in high caries risk patients.
- Conditions
- Caries
- Being tested
- Miswak toothpaste, Fluoride toothpaste
- Keywords
- Antibacterial, streptococcus mutans, miswak, fluoride
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Miswak toothpasteOther
Also called Dabur meswak
Dabur Meswak is scientifically formulated herbal toothpaste with pure extract of the Miswak plant 'Salvadore Persica'
Fluoride toothpasteOther
Also called Signal toothpaste
1450 ppm fluoride toothpaste
| Study group | Role | What they receive |
|---|---|---|
| Miswak toothpaste | Experimental | Dabur meswak herpal toothpaste Receives: Other: Miswak toothpaste |
| Fluoride toothpaste | Active comparator | Signal fluoride toothpaste, containing 1450 ppm of fluoride Receives: Other: Fluoride toothpaste |
What is being measured
The primary outcome is the main question the study is designed to answer.
streptococcus mutans count
Counting streptococcus mutans, Measurement: Mitis-Salivarius agar plate, Unit: CFUs/mL
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2021
- Study start1 Dec 2021 (estimated)
- Primary completion30 Mar 2022 (estimated)
- Study completion30 Apr 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Outcomes assessor
- Enrolment
- 32 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Omar Osama Shaalan, Cairo University
- Investigators
- Omar O Shaalan, PhD, Principal investigator, Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05109299
- Sponsor's protocol ID
- miswak
- Status last verified
- Oct 2021
- First submitted
- 15 Oct 2021
- Last updated
- 5 Nov 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Antibacterial Effect of Miswak Toothpaste Compared to Fluoride Toothpaste in High Caries Risk Patients: Randomized Clinical Trial
- ClinicalTrials.gov ID
- NCT05109299
- Acronym / sponsor ID
- miswak
- Conditions
- Caries
- Keywords
- Antibacterial, streptococcus mutans, miswak, fluoride
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 32 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Dec 2021 (estimated)
- Primary completion
- 30 Mar 2022 (estimated)
- Study completion
- 30 Apr 2022 (estimated)
- First posted
- 5 Nov 2021 (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.
Meswak is scientifically formulated herbal toothpaste with pure extract of the Miswak plant 'Salvadore Persica', the famous 'Toothbrush Tree' used for centuries. The astringent and anti-bacterial properties of Meswak helps reduce tooth decay , fight plaque and prevent gum diseases. Miswak Herb is a rare, potent, priceless, wonder herb that delivers incredible Dental Care benefits.
Detailed description
This study is a randomized clinical trial, with parallel study design, 1:1 allocation ratio and superiority framework. The aim of the current trial is to evaluate antibacterial effect miswak toothpaste compared to fluoride toothpaste in high caries risk patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miswak toothpaste | Experimental | Other: Miswak toothpasteDabur meswak herpal toothpaste |
| Fluoride toothpaste | Active comparator | Other: Fluoride toothpasteSignal fluoride toothpaste, containing 1450 ppm of fluoride |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- High caries risk patients.
- At least one carious tooth according to CAT caries risk assessment model.
- Patient compliance
Key exclusion criteria (5 listed)
- Participant in another trial.
- Using another antimicrobial agents since one month of sampling.
- Systemic diseases or concomitant medication affecting salivary flow.
- Parafunctional habits.
- Pregnancy.
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 |
|---|---|---|
| Miswak toothpasteAlso: Dabur meswakDabur Meswak is scientifically formulated herbal toothpaste with pure extract of the Miswak plant 'Salvadore Persica' | Other | Miswak toothpaste |
| Fluoride toothpasteAlso: Signal toothpaste1450 ppm fluoride toothpaste | Other | Fluoride toothpaste |
Primary outcome
streptococcus mutans count
Time frame: 3 months
Counting streptococcus mutans, Measurement: Mitis-Salivarius agar plate, Unit: CFUs/mL
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
- Individual participant dataSharing planned: No
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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.
Omar O Shaalan, PhD principal investigator
Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miswak toothpaste and Fluoride toothpaste in people with 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 3 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: status not confirmed, as of the sponsor's last update on 5 Nov 2021. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Omar O Shaalan, PhD (00201122665661, omar.shaalan@dentistry.cu.edu.eg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
streptococcus mutans count (time frame: 3 months). 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 5 Nov 2021.