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NCT Number: NCT07599397

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

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.

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Key information

Age range

20 year–60 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Early Phase 1

Primary location

Ahram Canadian University

Giza, Egypt

Location contact

Marwa ElSayed Abbas ElSayed, Lecturer

PRINCIPAL_INVESTIGATOR

Noha Shaaban Shams Shams, Associate professor

CONTACT

[email protected]

01011459366 ext. +02

Noha Shaaban Shams, Associate professor

PRINCIPAL_INVESTIGATOR

About this study

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).

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Salvadora Persica Root

Behavioral

Miswak chewing sticks will be used as an alternative to the toothbrush

Toothbrushing

Behavioral

Modified Bass technique will be employed

Primary outcomes

  1. 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

Study contacts

Contact information is provided by the study sponsor or research team.

Marwa ElSayed Abbas ElSayed, PhD/Lecturer

CONTACT

[email protected]

01092221005 ext. +02

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Official study 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

Important dates

Study start
2026
Primary completion
2026
Study completion
2026
First posted
May 20, 2026
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.