Plaque, DentalPhase 3NCT04137393
The Effect of Brushing With Salvadorapersica (Miswak) Sticks on Salivary Streptococcus Mutants and Plaque Level in Children: A Clinical Trial
A Phase 3 study testing brushing in people with Plaque, Dental, run by Heba sabbagh.
Trial summary
Objectives: to evaluate the effect of brushing with Salvadora persica (Miswak) on streptococcus mutants compared to brushing with fluoridated tooth paste (FTP) in children. Methods: A total of 94 healthy children (8 years old) from an elementary governmental school in Jeddah, Saudi Arabia were grouped to Miswak and… Read more about this study
- Who is it for?
- Ages 8 to 9 years, men only
- Conditions the study is for
- Plaque, Dental
- What is being tested?
- brushing
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 70 participants
- Where
- No sites listed yet
- Study dates
- Oct 2016to Jun 2018
- Phase
- Phase 3
- 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 8 to 9 years
- Men only
- No healthy volunteers
- Child
Who may be able to join
- Healthy children
- age from 8 to 9
- parents signed the consent form they attended morning session for brushing
Who cannot join
- medical compromised children
- parents did not sign the consent form Did not attend morning session
About this study
Objectives:
to evaluate the effect of brushing with Salvadora persica (Miswak) on streptococcus mutants compared to brushing with fluoridated tooth paste (FTP) in children.
Methods:
A total of 94 healthy children (8 years old) from an elementary governmental school in Jeddah, Saudi Arabia were grouped to Miswak and FTP groups. They were assessed for their salivary level of mutans streptococci species, and lactobacillus at the baseline and three weeks after brushing. Caries level using DMFT/dmft, and plaque amount using Greene Vermillion simplified oral hygiene index were recorded.
- Conditions
- Plaque, Dental
- Being tested
- brushing
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
brushingCombination product
mechanical and chemical plaque removal
| Study group | Role | What they receive |
|---|---|---|
| Salvadora persica | Experimental | brush teeth with Salvadora persica "Miswak" Receives: Combination Product: brushing |
| tooth brush | Active comparator | brush with fluoridated tooth paste Receives: Combination Product: brushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
green and vermillion
plaque level
Measured: 4 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Oct 2019
- Study startOct 2016
- Primary completionOct 2017
- Study completionJun 2018
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Plaque, DentalStudies 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 70 participants (actual)
Sponsor and investigators
- Lead sponsor
- Heba sabbagh
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Heba sabbagh, King Abdulaziz University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04137393
- Sponsor's protocol ID
- 006-16
- Status last verified
- Oct 2019
- First submitted
- 22 Oct 2019
- Last updated
- 24 Oct 2019
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Publications
Sabbagh HJ, AlGhamdi KS, Mujalled HT, Bagher SM. The effect of brushing with Salvadora persica (miswak) sticks on salivary Streptococcus mutans and plaque levels in children: a clinical trial. BMC Complement Med Ther. 2020 Feb 13;20(1):53. doi: 10.1186/s12906-020-2847-3.
PubMed 32054468
Study at a glance
From the registry record, last updated by the sponsor on 24 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Brushing With Salvadorapersica (Miswak) Sticks on Salivary Streptococcus Mutants and Plaque Level in Children: A Clinical Trial
- ClinicalTrials.gov ID
- NCT04137393
- Acronym / sponsor ID
- 006-16
- Conditions
- Plaque, Dental
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 70 participants (actual)
- Lead sponsor
- Heba sabbaghUniversity, hospital or other
- Study start
- Oct 2016 (actual)
- Primary completion
- Oct 2017 (actual)
- Study completion
- Jun 2018 (actual)
- First posted
- 24 Oct 2019 (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.
Objectives:
to evaluate the effect of brushing with Salvadora persica (Miswak) on streptococcus mutants compared to brushing with fluoridated tooth paste (FTP) in children.
Methods:
A total of 94 healthy children (8 years old) from an elementary governmental school in Jeddah, Saudi Arabia were grouped to Miswak and FTP groups. They were assessed for their salivary level of mutans streptococci species, and lactobacillus at the baseline and three weeks after brushing. Caries level using DMFT/dmft, and plaque amount using Greene Vermillion simplified oral hygiene index were recorded.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Salvadora persica | Experimental | Combination Product: brushingbrush teeth with Salvadora persica "Miswak" |
| tooth brush | Active comparator | Combination Product: brushingbrush with fluoridated tooth paste |
Who may qualify
- Ages
- 8 to 9 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child
Key inclusion criteria (3 listed)
- Healthy children
- age from 8 to 9
- parents signed the consent form they attended morning session for brushing
Key exclusion criteria (2 listed)
- medical compromised children
- parents did not sign the consent form Did not attend morning session
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 |
|---|---|---|
| brushingmechanical and chemical plaque removal | Combination product | Salvadora persica, tooth brush |
Primary outcome
green and vermillion
Time frame: 4 months
plaque level
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 24 Oct 2019.
- Derived from this study: PubMed 32054468Sabbagh HJ, AlGhamdi KS, Mujalled HT, Bagher SM. The effect of brushing with Salvadora persica (miswak) sticks on salivary Streptococcus mutans and plaque levels in children: a clinical trial. BMC Complement Med Ther. 2020 Feb 13;20(1):53. doi: 10.1186/s12906-020-2847-3.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing brushing in people with Plaque, Dental, run by Heba sabbagh.
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 2 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 24 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.
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.
What does this phase mean?
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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?
green and vermillion (time frame: 4 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04137393, which also lists 1 linked publication.
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 24 Oct 2019.