- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01336179
Comparative Effect of Chewing Sticks and Toothbrushing on Plaque Removal and Gingival Health
May 31, 2011 updated by: Taibah University
The Efficacy of the Miswak Chewing Sticks (Salvadora Persica)on Plaque Removal and Gingival Health: Randomised Clinical Trial
The purpose of the proposed study is to compare the effect of chewing sticks (Miswak) and the toothbrushes on plaque removal and gingival health.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Detailed Description
Dental plaque removal is essential in maintaining oral health.
Methods for oral hygiene vary from country to country and from culture to culture.
The use of a wood stick (miswak or chewing stick) for brushing the teeth is considered an important tool for oral hygiene care in many Afro-Asian communities.
The aim of the study is to compare the effect of the chewing stick (miswak), and toothbrushing on plaque removal and gingival health.
The participants comprise 18 healthy Saudi Arabian male volunteers aged 21 to 30 years, at Taibah University in Saudi Arabia.
The study was designed as a single, blind, randomized split-mouth study.
Professional tooth cleaning was conducted, and after six weeks use of either the miswak or toothbrush on each quadrant, modified plaque and gingival indices, were recorded.
Study Type
Interventional
Enrollment (Anticipated)
18
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Almadinah, Saudi Arabia, 04
- Faculty of Dentistry Taibah University
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
20 years to 30 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
Male
Description
Inclusion Criteria:
- Healthy individuals
- presence of at least 14 teeth
Exclusion Criteria:
- Subjects on medications (antiinflammatory or antibiotics)
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Single Group Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Miswak, dental plaque and gingivitis
|
twice daily use, two minutes interval
|
|
Active Comparator: Toothbrush, dental plaque and gingivitis
|
Twice daily use two minutes interval
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Miswak is useful for removing plaque and preventing gingivitis
Time Frame: 6 weeks
|
Miswak will be compared to toothbrush as a mechanical plaque control device, by calculating plaque index and gingival index scores for participants after 6 weeks of use.
|
6 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Tareq AS Abu Saleh, MSc, MRD, Assistant professor in Periodontics, Taibah University
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
March 1, 2011
Primary Completion (Actual)
April 1, 2011
Study Completion (Actual)
May 1, 2011
Study Registration Dates
First Submitted
April 6, 2011
First Submitted That Met QC Criteria
April 13, 2011
First Posted (Estimate)
April 15, 2011
Study Record Updates
Last Update Posted (Estimate)
June 1, 2011
Last Update Submitted That Met QC Criteria
May 31, 2011
Last Verified
April 1, 2011
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- UTFD201127021
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
product manufactured in and exported from the U.S.
No
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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