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

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.

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Key information

Conditions

Periodontitis Chronic Generalized Moderate

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

department of periodontology. Faculty of dentistry. Alexandria University

Alexandria, 21521, Egypt

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Cymbopogon citratus (lemongrass) oil gel

Drug

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

Primary outcomes

Change in periodontal pocket depth

Time frame: baseline and after 12 weeks

the distance between the gingival margin and depth of probing
Change in clinical attachment loss

Time frame: baseline and after 12 weeks

the distance between the CEJ and depth of probing
Change in Matrix metalloproteinase-8 level

Time frame: baseline and after 12 weeks

Human Matrix metalloproteinase-8 level intracrevicularlly by collection of crevicular fluid sample

Sponsors and collaborators

Lead sponsor

Souzy Kamal

Other

Registry information

Official study 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

Important dates

Study start: 2019
Primary completion: 2020
Study completion: 2021
First posted: Feb 15, 2022
Registry last updated: Feb 15, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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