Dental CariesNCT07409610
Miswak (Salvadora Persica) Versus a Toothbrush in Plaque Removal
A study testing Miswak and Toothbrush in people with Dental Caries and Dental Plaque Accumulation, run by King Abdulaziz University at 1 site in Saudi Arabia.
Trial summary
The study investigates the effectiveness of a 45°-cut miswak for plaque removal compared to a toothbrush in children and assesses their preferences for these tools. Conducted at King Abdulaziz University Dental Hospital, it employs a split-mouth randomized controlled trial design to measure plaque levels and gather… Read more about this study
- Who is it for?
- Ages 6 to 14 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Caries, Dental Plaque Accumulation
- What is being tested?
- Miswak and Toothbrush
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 82 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- 12 Sep 2025to 19 Jan 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 6 to 14 years
- All sexes
- Healthy volunteers accepted
- Child
Who may be able to join
- Healthy children aged 6 to 14 years.
- Children who their parents/legal guardians have approved and signed the consent form, which ensures that the participants are within the target age range and are healthy, which helps to control variables that could affect oral hygiene outcomes.
Who cannot join
- Unhealthy children
- Children whose ages are below 6 years or above 14 years
- Children with orthodontic brackets because it can affect oral hygiene practices and outcomes, excluding these participants ensures a more homogeneous sample.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Effectiveness of a 45°-Cut Miswak (Salvadora Persica) Versus a Toothbrush in Plaque Removal Among Children: A Randomized Split-Mouth Clinical Trial
The study investigates the effectiveness of a 45°-cut miswak for plaque removal compared to a toothbrush in children and assesses their preferences for these tools. Conducted at King Abdulaziz University Dental Hospital, it employs a split-mouth randomized controlled trial design to measure plaque levels and gather feedback through a questionnaire.
Read the detailed description
Miswak provides both mechanical and chemical cleaning. Its fibrous structure enables mechanical removal of debris from tooth surfaces and interdental areas, while naturally occurring compounds (e.g., fluoride, silica, and calcium) may contribute to its anticariogenic effects. Studies have reported that miswak exhibits antibacterial, antifungal, antiviral, anti-cariogenic, and antioxidant effects, and molecular docking studies have suggested potential anti-COVID-19 activity.
One of the studies has shown that miswak can reduce oral bacterial load, in some cases more effectively than conventional toothpaste particularly against Streptococcus mutans and Lactobacilli, key contributors to dental caries. Miswak-based toothpaste and mouthwash have also been associated with significant reductions in plaque levels and improved gingival health, suggesting that miswak could be a viable and affordable oral hygiene option, especially for children in underserved or resource-limited communities
Methods:
This research employs a split-mouth randomized controlled trial (RCT) design that compared the effectiveness of a 45-degree cut Miswak stick versus a manual toothbrush in reducing dental plaque among children aged 6 to 14 years. The study focused on evaluating intra-individual differences in plaque accumulation by assigning each child to use Miswak on one side of the mouth and a toothbrush on the opposite side. This split-mouth approach aims to minimize variability and enhance statistical reliability.
This design supported intra-individual comparison and enhanced the study's internal validity.
- Group A (n=36) used a manual toothbrush on the left upper and lower quadrants and a 45-degree cut Miswak on the right quadrants.
- Group B (n=36) followed the reverse assignment, using the toothbrush on the right and Miswak on the left
- Conditions
- Dental Caries, Dental Plaque Accumulation
- Being tested
- Miswak, Toothbrush
- Keywords
- Salvadora persica, Brushing technique, plaque removal, Miswak
- Medical subject headings
- Dental Caries
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MiswakOther
Also called Salvadora persica
Miswak is a traditional oral hygiene tool made from the twigs of the Salvadora persica tree. It's used for cleaning teeth and has natural antibacterial properties. Miswak is popular in many cultures, particularly in the Middle East and parts of Africa, and is valued for its effectiveness in promoting oral health.
ToothbrushOther
A toothbrush is a small, handheld device used for cleaning teeth and maintaining oral hygiene. It typically consists of a handle and a head with bristles that help remove plaque, food particles, and bacteria from the teeth and gums, often used in conjunction with toothpaste.
| Study group | Role | What they receive |
|---|---|---|
| Intervention (Miswak) | Experimental | This arm introduces a 45° miswak technique, which aligns with the modified Bass method by angling the miswak fibers at 45° toward the gingival margin Receives: Other: Miswak |
| Control (Tooth brushing) | Active comparator | Participants in this arm used the modified bass technique using normal tooth brush and tooth paste Receives: Other: Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
The plaque index score
The plaque index score, a continuous measure assessed using the Simplified Oral Hygiene Index (OHI-S) developed by Greene and Vermillion (1964) (Greene and Vermillion 1964)
Measured: At baseline and after 3 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Feb 2026
- Study start12 Sep 2025
- Primary completion12 Dec 2025
- Study completion19 Jan 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Dental CariesStudies 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 82 participants (actual)
Sponsor and investigators
- Lead sponsor
- King Abdulaziz University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Heba sabbagh, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07409610
- Sponsor's protocol ID
- 35-03-25
- Other IDs
- institutional review board
- Status last verified
- Feb 2026
- First submitted
- 19 Jan 2026
- Last updated
- 13 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effectiveness of a 45°-Cut Miswak (Salvadora Persica) Versus a Toothbrush in Plaque Removal Among Children: A Randomized Split-Mouth Clinical Trial
- ClinicalTrials.gov ID
- NCT07409610
- Acronym / sponsor ID
- 35-03-25
- Conditions
- Dental Caries, Dental Plaque Accumulation
- Keywords
- Salvadora persica, Brushing technique, plaque removal, Miswak
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 82 participants (actual)
- Lead sponsor
- King Abdulaziz UniversityUniversity, hospital or other
- Study start
- 12 Sep 2025 (actual)
- Primary completion
- 12 Dec 2025 (actual)
- Study completion
- 19 Jan 2026 (actual)
- First posted
- 13 Feb 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.
The study investigates the effectiveness of a 45°-cut miswak for plaque removal compared to a toothbrush in children and assesses their preferences for these tools. Conducted at King Abdulaziz University Dental Hospital, it employs a split-mouth randomized controlled trial design to measure plaque levels and gather feedback through a questionnaire.
Detailed description
Miswak provides both mechanical and chemical cleaning. Its fibrous structure enables mechanical removal of debris from tooth surfaces and interdental areas, while naturally occurring compounds (e.g., fluoride, silica, and calcium) may contribute to its anticariogenic effects. Studies have reported that miswak exhibits antibacterial, antifungal, antiviral, anti-cariogenic, and antioxidant effects, and molecular docking studies have suggested potential anti-COVID-19 activity.
One of the studies has shown that miswak can reduce oral bacterial load, in some cases more effectively than conventional toothpaste particularly against Streptococcus mutans and Lactobacilli, key contributors to dental caries. Miswak-based toothpaste and mouthwash have also been associated with significant reductions in plaque levels and improved gingival health, suggesting that miswak could be a viable and affordable oral hygiene option, especially for children in underserved or resource-limited communities
Methods:
This research employs a split-mouth randomized controlled trial (RCT) design that compared the effectiveness of a 45-degree cut Miswak stick versus a manual toothbrush in reducing dental plaque among children aged 6 to 14 years. The study focused on evaluating intra-individual differences in plaque accumulation by assigning each child to use Miswak on one side of the mouth and a toothbrush on the opposite side. This split-mouth approach aims to minimize variability and enhance statistical reliability.
This design supported intra-individual comparison and enhanced the study's internal validity.
- Group A (n=36) used a manual toothbrush on the left upper and lower quadrants and a 45-degree cut Miswak on the right quadrants.
- Group B (n=36) followed the reverse assignment, using the toothbrush on the right and Miswak on the left
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intervention (Miswak) | Experimental | Other: MiswakThis arm introduces a 45° miswak technique, which aligns with the modified Bass method by angling the miswak fibers at 45° toward the gingival margin |
| Control (Tooth brushing) | Active comparator | Other: ToothbrushParticipants in this arm used the modified bass technique using normal tooth brush and tooth paste |
Who may qualify
- Ages
- 6 to 14 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child
Key inclusion criteria (2 listed)
- Healthy children aged 6 to 14 years.
- Children who their parents/legal guardians have approved and signed the consent form, which ensures that the participants are within the target age range and are healthy, which helps to control variables that could affect oral hygiene outcomes.
Key exclusion criteria (3 listed)
- Unhealthy children
- Children whose ages are below 6 years or above 14 years
- Children with orthodontic brackets because it can affect oral hygiene practices and outcomes, excluding these participants ensures a more homogeneous sample.
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 |
|---|---|---|
| MiswakAlso: Salvadora persicaMiswak is a traditional oral hygiene tool made from the twigs of the Salvadora persica tree. It's used for cleaning teeth and has natural antibacterial properties. Miswak is popular in many cultures, particularly in the Middle East and parts of Africa, and is valued for its effectiveness in promoting oral health. | Other | Intervention (Miswak) |
| ToothbrushA toothbrush is a small, handheld device used for cleaning teeth and maintaining oral hygiene. It typically consists of a handle and a head with bristles that help remove plaque, food particles, and bacteria from the teeth and gums, often used in conjunction with toothpaste. | Other | Control (Tooth brushing) |
Primary outcome
The plaque index score
Time frame: At baseline and after 3 weeks
The plaque index score, a continuous measure assessed using the Simplified Oral Hygiene Index (OHI-S) developed by Greene and Vermillion (1964) (Greene and Vermillion 1964)
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 13 Feb 2026.
- Individual participant dataSharing planned: No
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Miswak and Toothbrush in people with Dental Caries and Dental Plaque Accumulation, run by King Abdulaziz University at 1 site in Saudi Arabia.
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 2 inclusion and 3 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 13 Feb 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 Saudi Arabia. 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?
The plaque index score (time frame: At baseline and after 3 weeks). 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 13 Feb 2026.