Clinical trial NCT04605289: Levels of Matrix Metalloproteinase-8 After Intrapocket Treatment in Moderate Periodontitis Patients.
Official title: Biochemical Efficacy of Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in Moderate Periodontitis Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Periodontitis
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2020-10-28
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: -Cymbopogon citratus oil gel /-Placebo gel. will be intrapocket application as an adjunctive treatment to conventional therapy
Primary purpose: TREATMENT

Brief summary: Using local delivery drugs as adjunctive to scaling and root planing and evaluating gingival crevicular fluid (GCF) biological molecular markers (MMP-8).

Detailed description: Study sample and setting A sample size of twenty patients per group (number of groups = 2) (total sample size = 40 patients) is the sufficient required sample as statistically significant with 80% power. The sample size was calculated using g power version 3.1.9.2. patients will be recruited from the outpatient clinic of the Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology. Faculty of Dentistry, Alexandria University.

Treatment will be in accordance with the principles of the modified Helsinki code for human clinical studies (2013).

The clinical study will be conducted following the ethical guidelines for conduct of research on human subjects, by the Faculty of Dentistry, Alexandria University (IRB NO:00010556 - IORG 0008839).

Data management and statistical analysis The data will be processed and analysed using statistical package for social sciences program SPSS (20.0) software\*. The study will include descriptive and analytical data. A P-value of less than 0.05 will be considered statistically significant.

Eligibility criteria: Inclusion Criteria:

1. Patients of both sexes having moderate periodontitis (stage II), CAL 3-4mm.
2. Patients' age between 25 and 45 years old.
3. Systemically healthy patients.
4. No history of periodontal therapy (surgical and non-surgical) or taken any antibiotic therapy for the past six months.

Exclusion Criteria:

1. History of smoking.
2. Patients having previous adverse reaction to the products (or similar products) used in this study.
3. Grade C category that has rapid rate of progression.
4. Pregnant and lactating women.

Primary outcomes:
measure: Changes of clinical attachment and periodontal probing pocket
timeFrame: at baseline and twelve weeks from intervention.
Secondary outcomes:
measure: GCF concentration of MMP-8
timeFrame: at baseline, one week, and twelve weeks from intervention.
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: Alexandria University
Study officials:
affiliation: Alexandria University
name: Nadein E Sharif
role: PRINCIPAL_INVESTIGATOR
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