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Antibacterial Effect of Miswak Toothpaste Compared to Fluoride Toothpaste

Sponsor
Cairo University (Other)
Overall Status
Not yet recruiting
CT.gov ID
NCT05109299
Collaborator
(none)
32
Enrollment
1
Location
2
Arms
4.9
Anticipated Duration (Months)
6.5
Patients Per Site Per Month

Study Details

Study Description

Brief 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. Miswak Herb is a rare, potent, priceless, wonder herb that delivers incredible Dental Care benefits.

Condition or Disease Intervention/Treatment Phase
  • Other: Miswak toothpaste
  • Other: Fluoride toothpaste
 N/A

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

Study Type:
Interventional
Anticipated Enrollment :
32 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Masking:
Double (Participant, Outcomes Assessor)
Primary Purpose:
Treatment
Official Title:
Antibacterial Effect of Miswak Toothpaste Compared to Fluoride Toothpaste in High Caries Risk Patients: Randomized Clinical Trial
Anticipated Study Start Date :
Dec 1, 2021
Anticipated Primary Completion Date :
Mar 30, 2022
Anticipated Study Completion Date :
Apr 30, 2022

Arms and Interventions

Arm Intervention/Treatment
Experimental: Miswak toothpaste

Dabur meswak herpal toothpaste

Other: Miswak toothpaste
Dabur Meswak is scientifically formulated herbal toothpaste with pure extract of the Miswak plant 'Salvadore Persica'
Other Names:
  • Dabur meswak

    		•
    Active Comparator: Fluoride toothpaste

    Signal fluoride toothpaste, containing 1450 ppm of fluoride

    Other: Fluoride toothpaste
    1450 ppm fluoride toothpaste
    Other Names:
  • Signal toothpaste

    		•

    Outcome Measures

    Primary Outcome Measures

    1. streptococcus mutans count [3 months]

      Counting streptococcus mutans, Measurement: Mitis-Salivarius agar plate, Unit: CFUs/mL

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 25 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    Inclusion Criteria:

    • High caries risk patients.

    • At least one carious tooth according to CAT caries risk assessment model.

    • Patient compliance

    Exclusion Criteria:

    • Participant in another trial.

    • Using another antimicrobial agents since one month of sampling.

    • Systemic diseases or concomitant medication affecting salivary flow.

    • Parafunctional habits.

    • Pregnancy.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Faculty of Dentistry, Cairo University Cairo El Manial Egypt 11553

    Sponsors and Collaborators

    • Cairo University

    Investigators

    • Principal Investigator: Omar O Shaalan, PhD, Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Omar Osama Shaalan, Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University
    ClinicalTrials.gov Identifier:
    NCT05109299
    Other Study ID Numbers:
    • miswak
    First Posted:
    Nov 5, 2021
    Last Update Posted:
    Nov 5, 2021
    Last Verified:
    Oct 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    No
    Plan to Share IPD:
    No
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Omar Osama Shaalan, Lecturer, Conservative Dentistry Department, Faculty of Dentistry, Cairo University
    Antibacterial, streptococcus mutans, miswak, fluoride
    Additional relevant MeSH terms:
    Fluorides

    Study Results

    No Results Posted as of Nov 5, 2021