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

Study Overview
=================
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.

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

Conditions
-----------------
Periodontitis

Intervention / Treatment
-----------------
* Drug: lemongrass essential oil gel
* Drug: Placebo
* Procedure: Scaling and root planing


Participation Criteria
=================
Eligibility Criteria
-----------------
Inclusion Criteria: Patients of both sexes having moderate periodontitis (stage II), CAL 3-4mm. Patients' age between 25 and 45 years old. Systemically healthy patients. No history of periodontal therapy (surgical and non-surgical) or taken any antibiotic therapy for the past six months. Exclusion Criteria: History of smoking. Patients having previous adverse reaction to the products (or similar products) used in this study. Grade C category that has rapid rate of progression. Pregnant and lactating women.

Ages Eligible for Study
-----------------
Minimum Age: 25 Years
Maximum Age: 45 Years

Sexes Eligible for Study
-----------------
All

Accepts Healthy Volunteers
-----------------
No

Study Plan
=================
How is the study designed?
-----------------

Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: -Cymbopogon citratus oil gel /-Placebo gel. will be intrapocket application as an adjunctive treatment to conventional therapy
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Group I (study group)<br>Scaling and root planing + intra-pocket application of 2% Cymbopogon citratus (lemon-grass) gel | Drug: lemongrass essential oil gel<br>* The lemongrass oil gel will be administered by means of a syringe with a bent, blunt-end needle. The needle will be carefully inserted into the periodontal pocket and the gel will be applied in the test sites in a gentle probing manner, attempting to fill the full extent of the pocket. The gel will be applied up to the gingival margin and the excess gel will be removed with sterile gauze. Periodontal dressing will be applied after the delivery of the drug, and they will be also asked not to eat for thirty minutes. After placement of the gel in situ, patients will be instructed to follow strict oral hygiene protocol and not chew hard or sticky foods at the gel placement sites for rest of the week.<br>* Other names: Cymbopogon citratus oil gel;Procedure: Scaling and root planing<br>* Conventional mechanical treatment by ultra-sonic scalers<br>|
| Placebo Comparator: Group II (control group)<br>Scaling and root planing +intra-pocket application of placebo gel | Drug: Placebo<br>* The placebo will be administered by means of a syringe with a bent, blunt-end needle. The needle will be carefully inserted into the periodontal pocket and the gel will be applied in the test sites in a gentle probing manner, attempting to fill the full extent of the pocket. The gel will be applied up to the gingival margin and the excess gel will be removed with sterile gauze. Periodontal dressing will be applied after the delivery of the drug, and they will be also asked not to eat for thirty minutes. After placement of the gel in situ, patients will be instructed to follow strict oral hygiene protocol and not chew hard or sticky foods at the gel placement sites for rest of the week.<br>* Other names: Carbopol®-Based pH-Sensitive gel;Procedure: Scaling and root planing<br>* Conventional mechanical treatment by ultra-sonic scalers<br>|

What is the study measuring?
-----------------
Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Changes of clinical attachment and periodontal probing pocket | Millimeters (mm) | at baseline and twelve weeks from intervention. | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GCF concentration of MMP-8 | pg/ml | at baseline, one week, and twelve weeks from intervention. |