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

Phase 4

Completed

• Conditions: Periodontitis Chronic Generalized Moderate
• Interventions: Drug: Cymbopogon citratus (lemongrass) oil gel

• Registration Number: NCT05241509
• Lead Sponsor: Souzy Kamal

Brief 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2019-07-06
• Primary Completion: 2020-12-14
• Study Completion: 2021-12-04
• Study First Submitted: 2022-01-27
• Status Verified: 2022-02
• Study First Submitted QC: 2022-02-05
• Last Update Submitted: 2022-02-05
• Study First Posted: 2022-02-15
• Last Update Posted: 2022-02-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group II (control)	Cymbopogon citratus (lemongrass) oil gel	included twenty treated with SRP and intrapocket application of placebo gel.
Group I (test)	Cymbopogon citratus (lemongrass) oil gel	included twenty patients treated with SRP and intrapocket application of 2% lemongrass oil gel.

Primary Outcome Measures

Name	Time	Method
Change in clinical attachment loss	baseline and after 12 weeks	the distance between the CEJ and depth of probing
Change in Matrix metalloproteinase-8 level	baseline and after 12 weeks	Human Matrix metalloproteinase-8 level intracrevicularlly by collection of crevicular fluid sample
Change in periodontal pocket depth	baseline and after 12 weeks	the distance between the gingival margin and depth of probing

Trial Locations

Locations (1)

department of periodontology. Faculty of dentistry. Alexandria University; 🇪🇬 Alexandria, Egypt