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

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

Status
Not yet recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07599397
Enrollment
24
Registered
2026-05-20
Start date
2026-06-01
Completion date
2026-12-01
Last updated
2026-05-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Stage II or Stage III Grade B Periodontitis

Brief 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 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).

Interventions

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

BEHAVIORALToothbrushing

Modified Bass technique will be employed

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Intervention model description

It is a correlation between the invitro findings, the clinical biomarkers and clinical outcomes

Eligibility

Sex/Gender
ALL
Age
20 Years to 60 Years
Healthy volunteers
No

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

Design outcomes

Primary

MeasureTime frameDescription
Matrix metalloproteinase-9 (MMP-9) level in gingival crevicular fluid (GCF)3 monthsGCF will be collected at baseline and after 3 months to assess the MMP-9 level change by ELISA kit

Countries

Egypt

Contacts

CONTACTMarwa ElSayed Abbas ElSayed, PhD/Lecturer
marwah.elsayed2015@gmail.com01092221005
STUDY_DIRECTORNoha Shaaban Shams, Associate professor

Ahram Canadian University

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 21, 2026