Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis

Periodontitis Chronic Generalized Moderate Clinical Trial

Official title:

Biochemical Efficacy of Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis: A Randomized Controlled Clinical Trial

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05241509
• Other study ID #: Lemon grass oil
• Status: Completed
• Phase: Phase 4
• Start date: July 6, 2019
• Est. completion date: December 4, 2021

Study information

• Verified date: February 2022
• Source: Alexandria University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Background: Phytotherapeutics is widely used nowadays as an adjunct to scaling and root planing (SRP) to modulate inflammatory host response and eradicate microbes. Matrix metalloproteinase-8 (MMP-8) is associated with the onset of inflammation and considered an indicative biomarker to the severity of inflammatory response. Since MMP-8 can be used as a predictive biomarker for treatment response; our research aimed to investigate clinically the effectiveness of intra-pocket application of Cymbopogon citratus (lemongrass oil) gel and biochemically on MMP-8 levels in gingival crevicular fluid (GCF) of stage II periodontitis patients.

Methods: A randomized controlled clinical trial was conducted on forty patients with stage II periodontitis, divided equally into two groups. Group-I (test) was managed by SRP with intra-pocket application of 2% lemongrass oil gel. Group-II (control) was managed by SRP with intra-pocket application of a placebo gel. Periodontal pocket depth (PPD) and clinical attachment loss (CAL) were measured for both groups, before treatment and twelve weeks after. Moreover, GCF was collected from both groups at baseline, one week, and twelve weeks after treatment. Then analysed by Enzyme-linked Assay (ELISA) technique.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: December 4, 2021
• Est. primary completion date: December 14, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 25 Years to 45 Years

Eligibility

Inclusion Criteria:

• systemically healthy individuals of both sexes having moderate periodontitis (stage II), CAL 3-4mm, with an age ranging from 25 to 45 years old.

• patients with no history of previous periodontal therapy or taken any antibiotic therapy for the past six months

Exclusion Criteria:

• history of smoking, previous adverse reaction to the products (or similar products) used in this study, grade C category that has rapid rate of progression, and pregnant or lactating women

Related Conditions & MeSH terms

• Periodontitis
• Periodontitis Chronic Generalized Moderate

Intervention

Drug:
• Cymbopogon citratus (lemongrass) oil gel
Biochemical Efficacy of Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis

Locations

Country	Name	City	State
Egypt	department of periodontology. Faculty of dentistry. Alexandria University	Alexandria

Sponsors (1)

Lead Sponsor	Collaborator
Souzy Kamal

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in periodontal pocket depth	the distance between the gingival margin and depth of probing	baseline and after 12 weeks
Primary	Change in clinical attachment loss	the distance between the CEJ and depth of probing	baseline and after 12 weeks
Primary	Change in Matrix metalloproteinase-8 level	Human Matrix metalloproteinase-8 level intracrevicularlly by collection of crevicular fluid sample	baseline and after 12 weeks