Levels of Matrix Metalloproteinase-8 After Intrapocket Treatment in Moderate Periodontitis Patients.

Phase 1

Completed

• Conditions: Periodontitis
• Interventions: Drug: lemongrass essential oil gel; Drug: Placebo; Procedure: Scaling and root planing

• Registration Number: NCT04605289
• Lead Sponsor: Alexandria University

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.

Study Timeline

• Study Start: 2020-01-13
• Primary Completion: 2020-08-31
• Study Completion: 2020-10-14
• Study First Submitted: 2020-10-15
• Study First Submitted QC: 2020-10-21
• Study First Posted: 2020-10-28
• Status Verified: 2021-01
• Last Update Submitted: 2021-01-11
• Last Update Posted: 2021-01-12

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (control group)	Scaling and root planing	Scaling and root planing +intra-pocket application of placebo gel
Group I (study group)	lemongrass essential oil gel	Scaling and root planing + intra-pocket application of 2% Cymbopogon citratus (lemon-grass) gel
Group I (study group)	Scaling and root planing	Scaling and root planing + intra-pocket application of 2% Cymbopogon citratus (lemon-grass) gel
Group II (control group)	Placebo	Scaling and root planing +intra-pocket application of placebo gel

Primary Outcome Measures

Name	Time	Method
Changes of clinical attachment and periodontal probing pocket	at baseline and twelve weeks from intervention.	Millimeters (mm)

Secondary Outcome Measures

Name	Time	Method
GCF concentration of MMP-8	at baseline, one week, and twelve weeks from intervention.	pg/ml

Trial Locations

Locations (1)

Alexandria University; 🇪🇬 Alexandria, Egypt