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NCT Number: NCT07619014

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

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?

Recruiting

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Key information

Age range

18 year–30 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Al-Hawash Private University, Faculty of Dentistry

Homs, Syria

Location status: Recruiting

Location contact

Ali Abu Sulaiman, Ph.D. in Periodontology

CONTACT

[email protected]

+963956790836

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Natural Miswak (Al-Kureysh, Pakistan)

Device
  • 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.

Manual Toothbrush (Colgate Zig Zag, China)

Device
  • 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 outcomes

  1. 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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Ali Abu Sulaiman, Ph.D. in Periodontology

CONTACT

[email protected]

+963956790836

Fida Kaseeh, Ph.D. in Oral Medicine

CONTACT

[email protected]

Sponsors and collaborators

Lead sponsor

Al-Hawash Private University

Other

Registry information

Official study title

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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
Jun 1, 2026
Registry last updated
Jun 3, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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