NCT06538532

Brief 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
36

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2023

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 1, 2023

Completed
9 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

March 1, 2024

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

June 1, 2024

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

July 25, 2024

Completed
11 days until next milestone

First Posted

Study publicly available on registry

August 5, 2024

Completed
Last Updated

August 27, 2024

Status Verified

August 1, 2024

Enrollment Period

9 months

First QC Date

July 25, 2024

Last Update Submit

August 25, 2024

Conditions

Caries,DentalCaries Active

Outcome Measures

Primary Outcomes (3)

  • Streptomutans count

    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

    using pH meter

    3 months and 6 months

  • caries risk level

    According to ADA

    3 months and 6 months

Study Arms (2)

(A1) Zamzam water mouthwash

EXPERIMENTAL
Other: Zamzam water

(A2) Control group: will be on tooth brushing only

NO INTERVENTION

Interventions

Zamzam waterOTHER

Zamzam water

(A1) Zamzam water mouthwash

Eligibility Criteria

Age18 Years - 35 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Faculty of Dental medicine for Girls Al Azhar university

Cairo, 4434103, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth DemineralizationTooth DiseasesStomatognathic Diseases

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
TRIPLE
Who Masked
CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Principal Investigator

Study Record Dates

First Submitted

July 25, 2024

First Posted

August 5, 2024

Study Start

June 1, 2023

Primary Completion

March 1, 2024

Study Completion

June 1, 2024

Last Updated

August 27, 2024

Record last verified: 2024-08

Locations

EG(1)