NCT07619014

Brief Summary

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?

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
90

participants targeted

Target at P50-P75 for not_applicable

Timeline
2mo left

Started May 2026

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress38%
May 2026Aug 2026

Study Start

First participant enrolled

May 1, 2026

Completed
25 days until next milestone

First Submitted

Initial submission to the registry

May 26, 2026

Completed
6 days until next milestone

First Posted

Study publicly available on registry

June 1, 2026

Completed
29 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 30, 2026

Expected
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

August 30, 2026

Last Updated

June 3, 2026

Status Verified

May 1, 2026

Enrollment Period

2 months

First QC Date

May 26, 2026

Last Update Submit

May 31, 2026

Conditions

Keywords

ToothburshMiswakSiwakDental plaqueOrthodontic PatientsBraces

Outcome Measures

Primary Outcomes (1)

  • Modified Quigley-Hein Plaque Index (mQH) Score

    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).

Study Arms (2)

Miswak Side

ACTIVE COMPARATOR

50% of the mouth (Randomized half) assigned to be cleaned using the natural Miswak.

Device: Natural Miswak (Al-Kureysh, Pakistan)

Manual Toothbrush Side

ACTIVE COMPARATOR

The contralateral randomized side of the jaw assigned to be cleaned using a conventional manual toothbrush.

Device: Manual Toothbrush (Colgate Zig Zag, China)

Interventions

* 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.

Miswak Side

* 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.

Manual Toothbrush Side

Eligibility Criteria

Age18 Years - 30 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Al-Hawash Private University, Faculty of Dentistry

Homs, Syria

RECRUITING

MeSH Terms

Conditions

Dental Plaque

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic Diseases

Study Officials

  • Ali Abu Sulaiman

    Al-Hawash Private University

    STUDY CHAIR
  • Fida Kaseeh, Ph.D. in Oral Medicine

    Al-Hawash Private University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Ali Abu Sulaiman, Ph.D. in Periodontology

CONTACT

Fida Kaseeh, Ph.D. in Oral Medicine

CONTACT

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
OUTCOMES ASSESSOR
Purpose
SUPPORTIVE CARE
Intervention Model
FACTORIAL
Model Details: Split-Mouth Design (Each participant receives both interventions simultaneously on opposite sides of the jaw)
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 26, 2026

First Posted

June 1, 2026

Study Start

May 1, 2026

Primary Completion (Estimated)

June 30, 2026

Study Completion (Estimated)

August 30, 2026

Last Updated

June 3, 2026

Record last verified: 2026-05

Locations