Stage II or Stage III Grade B PeriodontitisEarly Phase 1NCT07599397
Evaluation of the Changes in Matrix Metalloproteinase-9 Levels With Salvadora Persica (Miswak) in Periodontal Fibroblasts and Gingival Crevicular Fluid in Patients With Periodontitis
A Early Phase 1 study testing Salvadora Persica Root and Toothbrushing in people with Stage II or Stage III Grade B Periodontitis, run by Cairo University at 1 site in Egypt.
Trial summary
The study is conducted to evaluate the invitro effect of Salvadora persica (miswak) extract on periodontal fibroblasts production of matrix metalloproteinase-9 (MMP-9) and prostaglandin E2 (PGE2) and correlating the results to clinical outcomes and biomarkers by assessing the MMP-9 and PGE2 levels in gingival… Read more about this study
- Who is it for?
- Ages 20 to 60 years
- Conditions the study is for
- Stage II or Stage III Grade B Periodontitis
- What is being tested?
- Salvadora Persica Root and Toothbrushing
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteEgypt
- Study dates
- 1 Jun 2026to 1 Dec 2026
- Phase
- Early Phase 1
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Stage II or III, grade B periodontitis
Who cannot join
- Have poor manual dexterity
- Systemic condition that may affect healing
- Administration of certain medications that may modify the outcomes
- Smoking patients
- Pregnant females
- Periapical involvement in teeth
Show all 10Show fewer
- Habitual or experienced users of miswak chewing sticks
- History of topical or systemic chemical plaque control during the past 6 months
- History of periodontal surgery during the past 6 months
- Local risk factor that interfere with accessibility for regular personal plaque control aids
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Egypt1 site
Ahram Canadian University
Giza
Noha Shaaban Shams Shams, Associate professor, 01011459366 ext. +02, noha.shams@gmail.com
Marwa ElSayed Abbas ElSayed, Lecturer
About this study
Official title: Evaluation of the Anti-inflammatory Effects of Salvadora Persica on Matrix Metalloproteinase-9 Levels in Periodontal Fibroblasts and Gingival Crevicular Fluid in Patients With Periodontitis: A Randomized Controlled Clinical Trial
The study is conducted to evaluate the invitro effect of Salvadora persica (miswak) extract on periodontal fibroblasts production of matrix metalloproteinase-9 (MMP-9) and prostaglandin E2 (PGE2) and correlating the results to clinical outcomes and biomarkers by assessing the MMP-9 and PGE2 levels in gingival crevicular fluid by a randomized controlled clinical trial comparing the use of toothbrush as the control group with miswak chewing stick as a substitute to personal mechanical plaque control in patients with stage II or III grade B periodontitis.
Read the detailed description
Despite the clinical benefits mentioned, miswak use have been associated with some drawbacks such as clinical attachment loss; improper use of miswak over a long period can result in a risk of oral tissues injury. To date, there is a lack of comprehensive evidence-based literature to guide a safe and effective accepted practice that can subsequently be used as oral hygiene instructions for miswak users. Correlation between the in vitro and in vivo findings will be performed to evaluate the translational relationship between the effects of miswak on periodontal fibroblast inflammatory activity and the corresponding clinical and biomarker outcomes in patients with periodontitis. Matrix metalloproteinase-9 (MMP-9) and prostaglandin E2 (PGE2) levels obtained from periodontal fibroblast cultures will be compared with gingival crevicular fluid (GCF) MMP-9 and PGE2 levels and clinical periodontal parameters, including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), and plaque index (PI).
- Being tested
- Salvadora Persica Root, Toothbrushing
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Salvadora Persica RootBehavioural
Miswak chewing sticks will be used as an alternative to the toothbrush
ToothbrushingBehavioural
Modified Bass technique will be employed
| Study group | Role | What they receive |
|---|---|---|
| Miswak group. | Experimental | The test group that will be assigned to use miswak chewing sticks for personal plaque Receives: Behavioral: Salvadora Persica Root |
| Toothbrush group | Experimental | The control group that will be assigned to use the toothbrush for personal plaque Receives: Behavioral: Toothbrushing |
What is being measured
The primary outcome is the main question the study is designed to answer.
Matrix metalloproteinase-9 (MMP-9) level in gingival crevicular fluid (GCF)
GCF will be collected at baseline and after 3 months to assess the MMP-9 level change by ELISA kit
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 May 2026
- Study start1 Jun 2026 (estimated)
- Primary completion1 Nov 2026 (estimated)
- Study completion1 Dec 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Stage II or Stage III Grade B PeriodontitisStudies of the same condition, open and under way.
- More trials run by Cairo UniversityThe sponsor's other registered studies.
- 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
- Early Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- It is a correlation between the invitro findings, the clinical biomarkers and clinical outcomes
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 24 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Cairo University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Marwa El Sayed Abbas Ahmed, Cairo University
- Investigators
- Noha Shaaban Shams, Associate professor, Study director, Ahram Canadian University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07599397
- Sponsor's protocol ID
- 123589
- Status last verified
- May 2026
- First submitted
- 14 May 2026
- Last updated
- 20 May 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 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Anti-inflammatory Effects of Salvadora Persica on Matrix Metalloproteinase-9 Levels in Periodontal Fibroblasts and Gingival Crevicular Fluid in Patients With Periodontitis: A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT07599397
- Acronym / sponsor ID
- 123589
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 24 participants (estimated)
- Lead sponsor
- Cairo UniversityUniversity, hospital or other
- Study start
- 1 Jun 2026 (estimated)
- Primary completion
- 1 Nov 2026 (estimated)
- Study completion
- 1 Dec 2026 (estimated)
- First posted
- 20 May 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 is conducted to evaluate the invitro effect of Salvadora persica (miswak) extract on periodontal fibroblasts production of matrix metalloproteinase-9 (MMP-9) and prostaglandin E2 (PGE2) and correlating the results to clinical outcomes and biomarkers by assessing the MMP-9 and PGE2 levels in gingival crevicular fluid by a randomized controlled clinical trial comparing the use of toothbrush as the control group with miswak chewing stick as a substitute to personal mechanical plaque control in patients with stage II or III grade B periodontitis.
Detailed description
Despite the clinical benefits mentioned, miswak use have been associated with some drawbacks such as clinical attachment loss; improper use of miswak over a long period can result in a risk of oral tissues injury. To date, there is a lack of comprehensive evidence-based literature to guide a safe and effective accepted practice that can subsequently be used as oral hygiene instructions for miswak users. Correlation between the in vitro and in vivo findings will be performed to evaluate the translational relationship between the effects of miswak on periodontal fibroblast inflammatory activity and the corresponding clinical and biomarker outcomes in patients with periodontitis. Matrix metalloproteinase-9 (MMP-9) and prostaglandin E2 (PGE2) levels obtained from periodontal fibroblast cultures will be compared with gingival crevicular fluid (GCF) MMP-9 and PGE2 levels and clinical periodontal parameters, including probing depth (PD), clinical attachment level (CAL), bleeding on probing (BOP), and plaque index (PI).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- It is a correlation between the invitro findings, the clinical biomarkers and clinical outcomes
| Arm | Type | Receives |
|---|---|---|
| Miswak group. | Experimental | Behavioral: Salvadora Persica RootThe test group that will be assigned to use miswak chewing sticks for personal plaque |
| Toothbrush group | Experimental | Behavioral: ToothbrushingThe control group that will be assigned to use the toothbrush for personal plaque |
Who may qualify
- Ages
- 20 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (1 listed)
- Stage II or III, grade B periodontitis
Key exclusion criteria (10 listed)
- Have poor manual dexterity
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 Persica RootMiswak chewing sticks will be used as an alternative to the toothbrush | Behavioural | Miswak group. |
| ToothbrushingModified Bass technique will be employed | Behavioural | Toothbrush group |
Primary outcome
Matrix metalloproteinase-9 (MMP-9) level in gingival crevicular fluid (GCF)
Time frame: 3 months
GCF will be collected at baseline and after 3 months to assess the MMP-9 level change by ELISA kit
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 May 2026.
- Individual participant dataSharing planned: No
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.
Noha Shaaban Shams, Associate professor study director
Ahram Canadian University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Salvadora Persica Root and Toothbrushing in people with Stage II or Stage III Grade B Periodontitis, run by Cairo University at 1 site in Egypt.
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 1 inclusion and 10 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: opening soon, as of the sponsor's last update on 20 May 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 Egypt. 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.
What does this phase mean?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Marwa ElSayed Abbas ElSayed, PhD/Lecturer (01092221005 ext. +02, marwah.elsayed2015@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Matrix metalloproteinase-9 (MMP-9) level in gingival crevicular fluid (GCF) (time frame: 3 months). 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 20 May 2026.