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CompletedNCT05241509Updated Feb 15, 2022

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

A Phase 4 interventional study of Cymbopogon citratus (lemongrass) oil gel in Periodontitis Chronic Generalized Moderate, sponsored by Souzy Kamal. Completed at 1 site in Egypt. Open to participants aged 25 Years to 45 Years. Per ClinicalTrials.gov, last updated 2022-02-15.

Sponsored by Souzy Kamal · Phase 4, Interventional, and Treatment

From the registry’s dates

  • Registered 2 years 6 months after the study started (first participant enrolled Jul 2019, registered Jan 2022).
Phase
Phase 4
Study type
Interventional
Enrollment
40
Allocation
Randomized
Ages
25 Years to 45 Years
Sex
All
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Study 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.

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Conditions studied

  • Periodontitis Chronic Generalized Moderate

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In context

Periodontitis

1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.

This study's enrollment of 40 is below the median of 45 across 1,191 interventional studies indexed under Periodontitis.

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Lead sponsor

This is the only study on the registry with Souzy Kamal as lead sponsor.

Counted across the registry records on this site, refreshed daily.

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Who can participate

Ages eligible
25 Years to 45 Years
Sexes eligible
All
Accepts healthy volunteers
No

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

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
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Study design

Phase
Phase 4
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Outcomes assessor)
Enrollment
40 participants (actual)

Study arms

  • Experimental
    Group I (test)

    included twenty patients treated with SRP and intrapocket application of 2% lemongrass oil gel.

    Drug: Cymbopogon citratus (lemongrass) oil gel

  • Placebo comparator
    Group II (control)

    included twenty treated with SRP and intrapocket application of placebo gel.

    Drug: Cymbopogon citratus (lemongrass) oil gel

Interventions

  • DrugCymbopogon 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

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What researchers measure

Primary outcomes

  1. Change in periodontal pocket depth

    the distance between the gingival margin and depth of probing

    Time frame: baseline and after 12 weeks

  2. Change in clinical attachment loss

    the distance between the CEJ and depth of probing

    Time frame: baseline and after 12 weeks

  3. Change in Matrix metalloproteinase-8 level

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

    Time frame: baseline and after 12 weeks

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Study locations

1 site
  • department of periodontology. Faculty of dentistry. Alexandria University
    Alexandria, 21521, Egypt
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References and documents

Individual participant data

Plan to share: Yes — all IPD that underlie results in a publication

Supporting information: Study protocol, Icf

No publications or documents are linked to this record.

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Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Feb 15, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
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Registry details

Key details

Study ID
NCT05241509
Lead sponsor
Souzy Kamal
Responsible party
Souzy Kamal (lecturer of oral medicine, periodontology, oral diagnosis and radiology, Alexandria University) — Sponsor-investigator
First posted
Feb 15, 2022
Start date
Jul 6, 2019
Primary completion
Dec 14, 2020
Completion
Dec 4, 2021
Last update
Feb 15, 2022

Study contacts

Souzy K. Anwar, Ph.D
principal investigator · periodontology department. Faculty of dentistry. Alexandria university

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2022. You cannot join it, but the record below documents what was studied.

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