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

NCT07599397 | Not Yet Recruiting Early Phase 1

• 1 other identifier: 123589
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

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.

Conditions

Stage II or Stage III Grade B Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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

  3 months

Study Arms (2)

Miswak group.

EXPERIMENTAL

The test group that will be assigned to use miswak chewing sticks for personal plaque

Behavioral: Salvadora Persica Root

Toothbrush group

EXPERIMENTAL

The control group that will be assigned to use the toothbrush for personal plaque

Behavioral: Toothbrushing

Interventions

Salvadora Persica Root BEHAVIORAL

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

Miswak group.

Toothbrushing BEHAVIORAL

Modified Bass technique will be employed

Toothbrush group

Eligibility Criteria

• Age: 20 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• Stage II or III, grade B periodontitis

You may not qualify if:

• 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

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Ahram Canadian University

Giza, Egypt

Location

MeSH Terms

Interventions

Toothbrushing

Intervention Hierarchy (Ancestors)

Oral Hygiene; Preventive Dentistry; Dentistry

Study Officials

• Noha Shaaban Shams, Associate professor

  Ahram Canadian University

  STUDY DIRECTOR

Central Study Contacts

Marwa ElSayed Abbas ElSayed, PhD/Lecturer

CONTACT

01092221005; marwah.elsayed2015@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Lecturer of Oral Medicine and Periodontology, Ahram Canadian University

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

Study Record Dates

• First Submitted: May 14, 2026
• First Posted: May 20, 2026
• Study Start (Estimated): June 1, 2026
• Primary Completion (Estimated): November 1, 2026
• Study Completion (Estimated): December 1, 2026
• Last Updated: May 20, 2026

Record last verified: 2026-05

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)