NCT04605289

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

Biochemical Efficacy of Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in Moderate Periodontitis Patients

• Status: Completed
• Phase: Phase 1 / Phase 2
• Study type: Interventional
• Enrollment: 40 (actual)
• Sponsor: Alexandria University · Academic / Other
• Sex: All
• Age: 25 Years – 45 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Periodontitis

Interventions

Type	Name	Description
DRUG	lemongrass essential oil gel	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.
DRUG	Placebo	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.
PROCEDURE	Scaling and root planing	Conventional mechanical treatment by ultra-sonic scalers

Timeline

• Start date: 2020-01-13
• Primary completion: 2020-08-31
• Completion: 2020-10-14
• First posted: 2020-10-28
• Last updated: 2021-01-12

Locations

1 site across 1 country: Egypt