Comparison of the Effectiveness of Miswak and Manual Toothbrush in Removing Dental Plaque in Fixed Orthodontic Patients

May 31, 2026 updated by: Al-Hawash Private University

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

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

Status

Indicates the current recruitment status or the expanded access status.
Recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
90

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • 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

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
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

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Al-Hawash Private University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • 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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
June 30, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 30, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 26, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 26, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
June 1, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 3, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 31, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant 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.

Clinical Trials on Dental Plaque

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings