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Recruiting NCT07619014

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

No phase Interventional Dental Plaque Orthodontic Patients

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Natural Miswak (Al-Kureysh, Pakistan), Manual Toothbrush (Colgate Zig Zag, China).
Who it may be relevant to
Registry conditions: Dental Plaque, Orthodontic Patients. Basic parameters: 18 years — 30 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Syria
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
Official title

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

Overview

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?

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • 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).]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: Yes

Study design

Allocation
Randomized
Model
Factorial
Masking
Single blind
Primary purpose
Supportive care

Study locations

Syria · 1 center
  • Al-Hawash Private University, Faculty of Dentistry — Homs

Identifiers

NCT: NCT07619014 · 26-06-2025

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗