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NCT05241509

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

Completed Phase 4 Last updated 15 February 2022
What this trial tests

Phase 4 trial testing Cymbopogon citratus (lemongrass) oil gel in Periodontitis Chronic Generalized Moderate in 40 participants. Completed in 4 December 2021.

Timeline
6 July 2019
Primary endpoint
14 December 2020
4 December 2021

Quick facts

Lead sponsorSouzy Kamal
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingdouble
Primary purposetreatment
Enrollment40
Start date6 July 2019
Primary completion14 December 2020
Estimated completion4 December 2021
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Souzy Kamal — full company profile →

Who can join

Adults 25 to 45, any sex, with Periodontitis Chronic Generalized Moderate. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

No peer-reviewed publications indexed yet for this trial. Completed trials usually publish results within 12-18 months.

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