- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07409610
Miswak (Salvadora Persica) Versus a Toothbrush in Plaque Removal
Effectiveness of a 45°-Cut Miswak (Salvadora Persica) Versus a Toothbrush in Plaque Removal Among Children: A Randomized Split-Mouth Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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 Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Jeddah, Saudi Arabia
- King Abdulaziz University
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
Accepts Healthy Volunteers
Description
Inclusion criteria included:
- 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.
Exclusion Criteria:
- 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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Intervention (Miswak)
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
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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.
Other Names:
|
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Active Comparator: Control (Tooth brushing)
Participants in this arm used the modified bass technique using normal tooth brush and tooth paste
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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.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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)
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At baseline and after 3 weeks
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Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 35-03-25
- Institutional Review Board (Other Identifier: The University of Tennessee Health Science Center)
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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