Plaque Induced GingivitisNCT01336179
Comparative Effect of Chewing Sticks and Toothbrushing on Plaque Removal and Gingival Health
A study testing Salvadora persica and Toothbrush in people with Plaque Induced Gingivitis, run by Taibah University at 1 site in Saudi Arabia.
Trial summary
The purpose of the proposed study is to compare the effect of chewing sticks (Miswak) and the toothbrushes on plaque removal and gingival health. Read more about this study
- Who is it for?
- Ages 20 to 30 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Plaque Induced Gingivitis
- What is being tested?
- Salvadora persica and Toothbrush
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteSaudi Arabia
- Study dates
- Mar 2011to May 2011
- 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 20 to 30 years
- Men only
- Healthy volunteers accepted
- Adult
Who may be able to join
- Healthy individuals
- presence of at least 14 teeth
Who cannot join
- Subjects on medications (antiinflammatory or antibiotics)
Trial locations and contacts
1 site in 1 country.
Saudi Arabia1 site
Faculty of Dentistry Taibah University
Al Madīnah, Almadinah, 04
About this study
Official title: 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.
Read the 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.
- Conditions
- Plaque Induced Gingivitis
- Being tested
- Salvadora persica, Toothbrush
- Keywords
- gingivitis, dental plaque, oral hygiene, toothbrush, chewing sticks
- Medical subject headings
- Gingivitis, Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salvadora persicaProcedure or surgery
twice daily use, two minutes interval
ToothbrushProcedure or surgery
Twice daily use two minutes interval
| Study group | Role | What they receive |
|---|---|---|
| Miswak, dental plaque and gingivitis | Experimental | Not described Receives: Procedure: Salvadora persica |
| Toothbrush, dental plaque and gingivitis | Active comparator | Not described Receives: Procedure: Toothbrush |
What is being measured
The primary outcome is the main question the study is designed to answer.
Miswak is useful for removing plaque and preventing gingivitis
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.
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2011 (estimated)
- Study startMar 2011
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Plaque Induced GingivitisStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind
- Who is masked
- Investigator
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Taibah University
- Sponsor type
- University, hospital or other
- Investigators
- Tareq AS Abu Saleh, MSc, MRD, Principal investigator, Assistant professor in Periodontics, Taibah University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01336179
- Sponsor's protocol ID
- UTFD201127021
- Status last verified
- Apr 2011
- First submitted
- 6 Apr 2011
- Last updated
- 1 Jun 2011
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 1 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Efficacy of the Miswak Chewing Sticks (Salvadora Persica)on Plaque Removal and Gingival Health: Randomised Clinical Trial
- ClinicalTrials.gov ID
- NCT01336179
- Acronym / sponsor ID
- UTFD201127021
- Conditions
- Plaque Induced Gingivitis
- Keywords
- gingivitis, dental plaque, oral hygiene, toothbrush, chewing sticks
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Taibah UniversityUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 15 Apr 2011 (estimated)
- 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 purpose of the proposed study is to compare the effect of chewing sticks (Miswak) and the toothbrushes on plaque removal and gingival health.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Single blind (investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Miswak, dental plaque and gingivitis | Experimental | Procedure: Salvadora persica |
| Toothbrush, dental plaque and gingivitis | Active comparator | Procedure: Toothbrush |
Who may qualify
- Ages
- 20 to 30 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- Healthy individuals
- presence of at least 14 teeth
Key exclusion criteria (1 listed)
- Subjects on medications (antiinflammatory or antibiotics)
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 |
|---|---|---|
| Salvadora persicatwice daily use, two minutes interval | Procedure or surgery | Miswak, dental plaque and gingivitis |
| ToothbrushTwice daily use two minutes interval | Procedure or surgery | Toothbrush, dental plaque and gingivitis |
Primary outcome
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.
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 1 Jun 2011.
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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.
Tareq AS Abu Saleh, MSc, MRD principal investigator
Assistant professor in Periodontics, Taibah 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 Salvadora persica and Toothbrush in people with Plaque Induced Gingivitis, run by Taibah 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 1 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 1 Jun 2011. 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?
Miswak is useful for removing plaque and preventing gingivitis (time frame: 6 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 1 Jun 2011.