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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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ClinicalTrials.gov Identifier: NCT05241509
Recruitment Status : Completed
First Posted : February 15, 2022
Last Update Posted : February 15, 2022
Sponsor:
Information provided by (Responsible Party):
Souzy Kamal, Alexandria University

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.


Condition or disease Intervention/treatment Phase
Periodontitis Chronic Generalized Moderate Drug: Cymbopogon citratus (lemongrass) oil gel Phase 4

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 40 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Outcomes Assessor)
Primary Purpose: Treatment
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
Actual Study Start Date : July 6, 2019
Actual Primary Completion Date : December 14, 2020
Actual Study Completion Date : December 4, 2021

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Group I (test)
included twenty patients treated with SRP and intrapocket application of 2% lemongrass oil gel.
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

Placebo Comparator: Group II (control)
included twenty treated with SRP and intrapocket application of placebo gel.
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




Primary Outcome Measures :
  1. Change in periodontal pocket depth [ Time Frame: baseline and after 12 weeks ]
    the distance between the gingival margin and depth of probing

  2. Change in clinical attachment loss [ Time Frame: baseline and after 12 weeks ]
    the distance between the CEJ and depth of probing

  3. 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



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Ages Eligible for Study:   25 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT05241509


Locations
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Egypt
department of periodontology. Faculty of dentistry. Alexandria University
Alexandria, Egypt, 21521
Sponsors and Collaborators
Souzy Kamal
Investigators
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Principal Investigator: Souzy K. Anwar, Ph.D periodontology department. Faculty of dentistry. Alexandria university
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Responsible Party: Souzy Kamal, lecturer of oral medicine, periodontology, oral diagnosis and radiology, Alexandria University
ClinicalTrials.gov Identifier: NCT05241509    
Other Study ID Numbers: Lemon grass oil
First Posted: February 15, 2022    Key Record Dates
Last Update Posted: February 15, 2022
Last Verified: February 2022
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: all IPD that underlie results in a publication
Supporting Materials: Study Protocol
Informed Consent Form (ICF)

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: Yes
Additional relevant MeSH terms:
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Periodontitis
Periodontal Diseases
Mouth Diseases
Stomatognathic Diseases