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

Alexandria University

Status and phase: Completed; Phase 2; Phase 1

Conditions: Periodontitis

Treatments: Procedure: Scaling and root planing; Drug: Placebo; Drug: lemongrass essential oil gel

Study type: Interventional

Funder types: Other

Identifiers

NCT04605289

17102019

Details and patient eligibility

About

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

Full 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.

Enrollment: 40 patients

Sex: All

Ages: 25 to 45 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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40 participants in 2 patient groups, including a placebo group

Group I (study group)

Experimental group

Description:

Scaling and root planing + intra-pocket application of 2% Cymbopogon citratus (lemon-grass) gel

Treatment:

Drug: lemongrass essential oil gel

Procedure: Scaling and root planing

Group II (control group)

Placebo Comparator group

Description:

Scaling and root planing +intra-pocket application of placebo gel

Treatment:

Drug: Placebo

Procedure: Scaling and root planing