Antibacterial Effect of Miswak Toothpaste Compared to Fluoride Toothpaste

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Caries
• Intervention / Treatment: Other: Miswak toothpaste; Other: Fluoride toothpaste

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 Type: Interventional
• Enrollment (Anticipated): 32
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Egypt
  • El Manial
    • Cairo, El Manial, Egypt, 11553
      • Faculty of Dentistry, Cairo University

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 25 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
streptococcus mutans count	Counting streptococcus mutans, Measurement: Mitis-Salivarius agar plate, Unit: CFUs/mL	3 months

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2021
• Primary Completion (Anticipated): March 30, 2022
• Study Completion (Anticipated): April 30, 2022

Study Registration Dates

• First Submitted: October 15, 2021
• First Submitted That Met QC Criteria: October 26, 2021
• First Posted (Actual): November 5, 2021

Study Record Updates

• Last Update Posted (Actual): November 5, 2021
• Last Update Submitted That Met QC Criteria: October 26, 2021
• Last Verified: October 1, 2021

More Information

Terms related to this study

• Keywords: Antibacterial, streptococcus mutans, miswak, fluoride
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Protective Agents; Cariostatic Agents; Fluorides
• Other Study ID Numbers: miswak

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No