Comparison of the Effectiveness of Miswak and Manual Toothbrush in Removing Dental Plaque in Fixed Orthodontic Patients: A Randomized Split-Mouth Clinical Trial

May 26, 2026 updated by: Al-Hawash Private University
This study compares the immediate plaque removal efficacy of the natural Miswak versus a traditional manual toothbrush using the Modified Bass technique among orthodontic patients. The main question it aims to answer is: Are there statistically significant differences in the post-brushing plaque index reduction between the dental arch side cleaned with Miswak and the contralateral side cleaned with a manual toothbrush?

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

The maintaining of excellent oral hygiene is a significant challenge for patients undergoing orthodontic treatment due to the presence of fixed brackets and archwires, which act as retentive areas for dental biofilm accumulation. While the conventional manual toothbrush is widely prescribed, the natural Miswak (Salvadora persica) serves as a popular traditional oral hygiene tool with documented mechanical and antimicrobial properties. However, there is a lack of split-mouth clinical trials directly evaluating and comparing their immediate mechanical efficacy in the presence of orthodontic appliances.

This study utilizes a split-mouth experimental design to minimize inter-individual variability, where each participant serves as their own control. The mouth of each patient is randomized to use the natural Miswak on one side and the conventional manual toothbrush on the contralateral side during a single clinical session with no subsequent follow-up.

Aim: To evaluate and compare the immediate efficacy of the natural Miswak versus a manual toothbrush (using the Modified Bass technique) in reducing dental plaque scores among a sample of patients with fixed orthodontic appliances at Al-Hawash Private University.

Study Type

Interventional

Enrollment (Estimated)

90

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 Contact

Study Contact Backup

Study Locations

  • Syria
      • Homs, Syria
        • Recruiting
        • Al-Hawash Private University, Faculty of Dentistry
        • Contact:

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:

  • Patients aged between 18 and 30 years old.
  • Presence of fixed orthodontic appliances (brackets and wires) on both upper and lower arches.
  • Good general systemic health with the absence of any medical conditions that might affect oral health status.

Exclusion Criteria:

  • Presence of advanced or aggressive periodontal diseases.
  • Current smokers.
  • Use of antimicrobial or antibacterial mouthwashes within 24 hours prior to the study session.
  • Systemic antibiotic intake within the past 2 weeks preceding the experiment.
  • Any physical or motor disability that could hinder the patient's capacity to perform proper tooth brushing.

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: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Factorial Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: Miswak Side
50% of the mouth (Randomized half) assigned to be cleaned using the natural Miswak.
Device: Natural Miswak (Al-Kureysh, Pakistan)
  • Preparation: 1-2 cm of outer bark removed, soaked in water for 10-15 mins, and fibers frayed.
  • Technique: Vertical strokes (gum to tooth), horizontal on occlusal, focusing around brackets.
  • Duration: 3 to 5 minutes.
Active Comparator: Manual Toothbrush Side
The contralateral randomized side of the jaw assigned to be cleaned using a conventional manual toothbrush.
Device: Manual Toothbrush (Colgate Zig Zag, China)
  • Technique: Modified Bass Technique (bristles at 45-degree angle to gingival margin, short vibratory movements) modified to brush above and below orthodontic brackets.
  • Duration: 3 to 5 minutes.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Modified Quigley-Hein Plaque Index (mQH) Score
Time Frame: Baseline (immediately before brushing) and Post-intervention (immediately after brushing within the same single clinical session).

Mesial, distal, and mid surfaces of facial and lingual aspects were scored. Scoring was as follows: 0 = no plaque/debris

  1. = separate flecks of plaque at the cervical margin of the tooth.
  2. = a thin continuous band of plaque (up to 1 mm) at the cervical margin of the tooth.
  3. = a band of plaque wider than 1 mm but covering less than one third of the crown of the tooth.
  4. = plaque covering at least one third but less than two thirds of the crown of the tooth.

  5. = plaque covering two thirds or more of the crown of the tooth.

    • Scores from all evaluated surfaces are summed together and then divided by the total number of sites evaluated to provide an average score for each mouth side per patient.
    • Plaque is disclosed using a basic fuchsin solution (VISUPLAC, Maquira, Brazil) applied via micro-applicators.
Baseline (immediately before brushing) and Post-intervention (immediately after brushing within the same single clinical session).

Collaborators and Investigators

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

Sponsor

Al-Hawash Private University

Investigators

  • Study Chair: Ali Abu Sulaiman, Al-Hawash Private University
  • Principal Investigator: Fida Kaseeh, Ph.D. in Oral Medicine, Al-Hawash Private 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)

May 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 30, 2026

Study Registration Dates

First Submitted

May 26, 2026

First Submitted That Met QC Criteria

May 26, 2026

First Posted (Actual)

June 1, 2026

Study Record Updates

Last Update Posted (Actual)

June 1, 2026

Last Update Submitted That Met QC Criteria

May 26, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 26-06-2025

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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