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

Periodontitis Clinical Trial

— MMP-8  

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04605289
• Other study ID #: 17102019
• Status: Completed
• Phase: Phase 1/Phase 2
• Start date: January 13, 2020
• Est. completion date: October 14, 2020

Study information

• Verified date: January 2021
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: October 14, 2020
• Est. primary completion date: August 31, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

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.

Related Conditions & MeSH terms

• Periodontitis

Intervention

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.
• 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

Locations

Country	Name	City	State
Egypt	Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Alexandria University

Country where clinical trial is conducted

Egypt, 

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* Note: There are 62 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Changes of clinical attachment and periodontal probing pocket	Millimeters (mm)	at baseline and twelve weeks from intervention.
Secondary	GCF concentration of MMP-8	pg/ml	at baseline, one week, and twelve weeks from intervention.