Anticariogenic Properties of Zamzam Water

August 25, 2024 updated by: Reham Youssef, Al-Azhar University

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:

i. Streptococcus mutans (S. mutans) count. ii. Oral pH. After 3 and 6 months interval.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

The present study aims to evaluate and compare the effect of Zamzam water mouthwashes in high caries-risk patients regarding:

i. 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 Type

Interventional

Enrollment (Actual)

36

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Cairo, Egypt, 4434103
        • Faculty of Dental Medicine for Girls Al Azhar University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

Yes

Description

Inclusion Criteria:

  • 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.

Exclusion Criteria:

  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Prevention
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: (A1) Zamzam water mouthwash
Other: Zamzam water
Zamzam water
No Intervention: (A2) Control group: will be on tooth brushing only

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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).
3 months and 6 months
Salivary PH level
Time Frame: 3 months and 6 months
using pH meter
3 months and 6 months
caries risk level
Time Frame: 3 months and 6 months
According to ADA
3 months and 6 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Al-Azhar University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

June 1, 2023

Primary Completion (Actual)

March 1, 2024

Study Completion (Actual)

June 1, 2024

Study Registration Dates

First Submitted

July 25, 2024

First Submitted That Met QC Criteria

August 2, 2024

First Posted (Actual)

August 5, 2024

Study Record Updates

Last Update Posted (Actual)

August 27, 2024

Last Update Submitted That Met QC Criteria

August 25, 2024

Last Verified

August 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • P-OP-24-01

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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