Dental PlaqueNCT07619014
Comparison of the Effectiveness of Miswak and Manual Toothbrush in Removing Dental Plaque in Fixed Orthodontic Patients
A study testing Natural Miswak (Al-Kureysh, Pakistan) and Manual Toothbrush (Colgate Zig Zag, China) in people with Dental Plaque and Orthodontic Patients, run by Al-Hawash Private University at 1 site in Syria.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 30 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Orthodontic Patients
- What is being tested?
- Natural Miswak (Al-Kureysh, Pakistan) and Manual Toothbrush (Colgate Zig Zag, China)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 45 participants
- Where
- 1 siteSyria
- Study dates
- 1 May 2026to 8 Sep 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 30 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
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
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?
Read the 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.
- Conditions
- Dental Plaque, Orthodontic Patients
- Being tested
- Natural Miswak (Al-Kureysh, Pakistan), Manual Toothbrush (Colgate Zig Zag, China)
- Keywords
- Toothbursh, Miswak, Siwak, Dental plaque, Orthodontic Patients, Braces
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
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.
| Study group | Role | What they receive |
|---|---|---|
| Miswak Side | Active comparator | 50% of the mouth (Randomized half) assigned to be cleaned using the natural Miswak. Receives: 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. Receives: Device: Manual Toothbrush (Colgate Zig Zag, China) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
- = 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.
Measured: Baseline (immediately before brushing) and Post-intervention (immediately after brushing within the same single clinical session).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jun 2026
- Study start1 May 2026
- Primary completion8 Sep 2026
- Study completion8 Sep 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental PlaqueStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Model description
- Split-Mouth Design (Each participant receives both interventions simultaneously on opposite sides of the jaw)
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 45 participants (actual)
Sponsor and investigators
- Lead sponsor
- Al-Hawash Private University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Ali Abu Sulaiman, Study chair, Al-Hawash Private UniversityFida Kaseeh, Ph.D. in Oral Medicine, Principal investigator, Al-Hawash Private University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07619014
- Sponsor's protocol ID
- 26-06-2025
- Status last verified
- May 2026
- First submitted
- 26 May 2026
- Last updated
- 10 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 10 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07619014
- Acronym / sponsor ID
- 26-06-2025
- Conditions
- Dental Plaque, Orthodontic Patients
- Keywords
- Toothbursh, Miswak, Siwak, Dental plaque, Orthodontic Patients, Braces
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 45 participants (actual)
- Lead sponsor
- Al-Hawash Private UniversityUniversity, hospital or other
- Study start
- 1 May 2026 (actual)
- Primary completion
- 8 Sep 2026 (actual)
- Study completion
- 8 Sep 2026 (actual)
- First posted
- 1 Jun 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Factorial
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Split-Mouth Design (Each participant receives both interventions simultaneously on opposite sides of the jaw)
| Arm | Type | Receives |
|---|---|---|
| Miswak Side | Active comparator | Device: Natural Miswak (Al-Kureysh, Pakistan)50% of the mouth (Randomized half) assigned to be cleaned using the natural Miswak. |
| Manual Toothbrush Side | Active comparator | Device: Manual Toothbrush (Colgate Zig Zag, China)The contralateral randomized side of the jaw assigned to be cleaned using a conventional manual toothbrush. |
Who may qualify
- Ages
- 18 to 30 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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 | Miswak Side |
| 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. | Device | Manual Toothbrush Side |
Primary outcome
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.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Sep 2026.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Ali Abu Sulaiman study chair
Al-Hawash Private University
Fida Kaseeh, Ph.D. in Oral Medicine principal investigator
Al-Hawash Private University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Natural Miswak (Al-Kureysh, Pakistan) and Manual Toothbrush (Colgate Zig Zag, China) in people with Dental Plaque and Orthodontic Patients, run by Al-Hawash Private University at 1 site in Syria.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 10 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Syria. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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).). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 10 Sep 2026.