Caries,DentalNCT06538532
Anticariogenic Properties of Zamzam Water
A study testing Zamzam water in people with Caries,Dental and Caries Active, run by Al-Azhar University at 1 site in Egypt.
Trial summary
The present study aims to evaluate and compare the effect of Zamzam water as mouthwashes in high caries-risk patients regarding: i. Streptococcus mutans (S. mutans) count. ii. Oral pH. After 3 and 6 months interval. Read more about this study
- Who is it for?
- Ages 18 to 35 yearsHealthy volunteers can take part
- Conditions the study is for
- Caries,Dental, Caries Active
- What is being tested?
- Zamzam water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 36 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2023to 1 Jun 2024
- 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 35 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Male or female participants aged between 18-35 years.
- Systemically- free individuals.
- High caries-risk patients according to ADA (American Dental Association).
- Not on a medication interfering with salivary secretion.
- Co-operative patients approved to participate in the study.
Who cannot join
- Patients who are already on any mouthwash regime.
- Patients who are on any medication that would alter the salivary secretion.
- Allergy to any of the ingredients of the study products.
Trial locations and contacts
1 site in 1 country.
Egypt1 site
Faculty of Dental medicine for Girls Al Azhar university
Cairo, 4434103
About this study
Official title: Effect of Zamzam Water on Streptococcus Mutans and Oral pH in High Caries-Risk Patients
The present study aims to evaluate and compare the effect of Zamzam water as mouthwashes in high caries-risk patients regarding:
- Streptococcus mutans (S. mutans) count. ii. Oral pH. After 3 and 6 months interval.
Read the detailed description
The present study aims to evaluate and compare the effect of Zamzam water mouthwashes in high caries-risk patients regarding:
- Streptococcus mutans (S. mutans) count. ii. Oral pH. all patients will be into two groups; The first group will use Zamzam water mouthwash for a six months with other preventive protocols including fissure sealants and preventive restorations wherever needed, while the second group will undergo preventive protocols only. During these six months, patients will be reassessed at three and six-month intervals regarding S. mutans count, oral pH, and caries risk level.
- Conditions
- Caries,Dental, Caries Active
- Being tested
- Zamzam water
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Zamzam waterOther
Zamzam water
| Study group | Role | What they receive |
|---|---|---|
| (A1) Zamzam water mouthwash | Experimental | Not described Receives: Other: Zamzam water |
| (A2) Control group: will be on tooth brushing only | No intervention | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Streptomutans count
measurements of Colony forming unit (CFU) will be performed using blood agar and mitis salivarius-bacitracin agar (MSBA).
Measured: 3 months and 6 months
Salivary PH level
using pH meter
Measured: 3 months and 6 months
caries risk level
According to ADA
Measured: 3 months and 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Aug 2024
- Study start1 Jun 2023
- Primary completion1 Mar 2024
- Study completion1 Jun 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Caries,DentalStudies of the same condition, open and under way.
- More trials run by Al-Azhar 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
- Triple blind
- Who is masked
- Care provider, Investigator, Outcomes assessor
- Enrolment
- 36 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Azhar University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Reham Youssef, Al-Azhar University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06538532
- Sponsor's protocol ID
- P-OP-24-01
- Status last verified
- Aug 2024
- First submitted
- 25 Jul 2024
- Last updated
- 27 Aug 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 27 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Zamzam Water on Streptococcus Mutans and Oral pH in High Caries-Risk Patients
- ClinicalTrials.gov ID
- NCT06538532
- Acronym / sponsor ID
- P-OP-24-01
- Conditions
- Caries,Dental, Caries Active
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 36 participants (actual)
- Lead sponsor
- Al-Azhar UniversityUniversity, hospital or other
- Study start
- 1 Jun 2023 (actual)
- Primary completion
- 1 Mar 2024 (actual)
- Study completion
- 1 Jun 2024 (actual)
- First posted
- 5 Aug 2024 (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.
The present study aims to evaluate and compare the effect of Zamzam water as mouthwashes in high caries-risk patients regarding:
- Streptococcus mutans (S. mutans) count. ii. Oral pH. After 3 and 6 months interval.
Detailed description
The present study aims to evaluate and compare the effect of Zamzam water mouthwashes in high caries-risk patients regarding:
- Streptococcus mutans (S. mutans) count. ii. Oral pH. all patients will be into two groups; The first group will use Zamzam water mouthwash for a six months with other preventive protocols including fissure sealants and preventive restorations wherever needed, while the second group will undergo preventive protocols only. During these six months, patients will be reassessed at three and six-month intervals regarding S. mutans count, oral pH, and caries risk level.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| (A1) Zamzam water mouthwash | Experimental | Other: Zamzam water |
| (A2) Control group: will be on tooth brushing only | No intervention | – |
Who may qualify
- Ages
- 18 to 35 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Male or female participants aged between 18-35 years.
- Systemically- free individuals.
- High caries-risk patients according to ADA (American Dental Association).
- Not on a medication interfering with salivary secretion.
- Co-operative patients approved to participate in the study.
Key exclusion criteria (3 listed)
- Patients who are already on any mouthwash regime.
- Patients who are on any medication that would alter the salivary secretion.
- Allergy to any of the ingredients of the study products.
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 |
|---|---|---|
| Zamzam waterZamzam water | Other | (A1) Zamzam water mouthwash |
Primary outcome
Streptomutans count
Time frame: 3 months and 6 months
measurements of Colony forming unit (CFU) will be performed using blood agar and mitis salivarius-bacitracin agar (MSBA).
Salivary PH level
Time frame: 3 months and 6 months
using pH meter
caries risk level
Time frame: 3 months and 6 months
According to ADA
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 27 Aug 2024.
- Individual participant dataSharing planned: Undecided
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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 Zamzam water in people with Caries,Dental and Caries Active, run by Al-Azhar 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 3 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 27 Aug 2024. 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?
Streptomutans count (time frame: 3 months and 6 months). The study lists 3 primary outcomes in all. 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 27 Aug 2024.