Evaluation of the Changes in Matrix Metalloproteinase-9 Levels With Salvadora Persica (Miswak) in Periodontal Fibroblasts and Gingival Crevicular Fluid in Patients With Periodontitis
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In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Salvadora Persica Root, Toothbrushing.
- Who it may be relevant to
- Registry conditions: Stage II or Stage III Grade B Periodontitis. Basic parameters: 20 years — 60 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- Egypt
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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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
Overview
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
- Behavioral Salvadora Persica Root
Miswak chewing sticks will be used as an alternative to the toothbrush - Behavioral Toothbrushing
Modified Bass technique will be employed
Primary outcome measures
- Matrix metalloproteinase-9 (MMP-9) level in gingival crevicular fluid (GCF) [Time frame: 3 months]
Eligibility criteria
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
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
Egypt · 1 center
- Ahram Canadian University — Giza
Identifiers
NCT: NCT07599397 · 123589