Evaluation of the Changes in Matrix Metalloproteinase-9 Levels With Salvadora Persica (Miswak) in Periodontal Fibroblasts and Gingival Crevicular Fluid in Patients With Periodontitis

May 14, 2026 updated by: Marwa El Sayed Abbas Ahmed, Cairo University

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

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 Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
24

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Early Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • Egypt
      • Giza, Egypt
        • Ahram Canadian University
        • Contact:
          • Noha Shaaban Shams Shams, Associate professor
          • Phone Number: +02 01011459366
          • Email: noha.shams@gmail.com
        • Principal Investigator:
          • Marwa ElSayed Abbas ElSayed, Lecturer
        • Principal Investigator:
          • Noha Shaaban Shams, Associate professor

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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  • Stage II or III, grade B periodontitis

Exclusion Criteria:

  • 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
    • 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

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: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Miswak group.
The test group that will be assigned to use miswak chewing sticks for personal plaque
Behavioral: Salvadora Persica Root
Miswak chewing sticks will be used as an alternative to the toothbrush
Experimental: Toothbrush group
The control group that will be assigned to use the toothbrush for personal plaque
Behavioral: Toothbrushing
Modified Bass technique will be employed

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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
3 months

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Cairo University

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Noha Shaaban Shams, Associate professor, Ahram Canadian 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 (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2026

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
November 1, 2026

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
December 1, 2026

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
May 14, 2026

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
May 20, 2026

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
May 20, 2026

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 14, 2026

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 123589

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

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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