Back to resultsCymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis
Primary Purpose
Periodontitis Chronic Generalized Moderate
Status
Completed
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
Cymbopogon citratus (lemongrass) oil gel
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis Chronic Generalized Moderate
Eligibility 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
Sites / Locations
- department of periodontology. Faculty of dentistry. Alexandria University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group I (test)
Group II (control)
Arm Description
included twenty patients treated with SRP and intrapocket application of 2% lemongrass oil gel.
included twenty treated with SRP and intrapocket application of placebo gel.
Outcomes
Primary Outcome Measures
Change in periodontal pocket depth
the distance between the gingival margin and depth of probing
Change in clinical attachment loss
the distance between the CEJ and depth of probing
Change in Matrix metalloproteinase-8 level
Human Matrix metalloproteinase-8 level intracrevicularlly by collection of crevicular fluid sample
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT05241509
Brief Title
Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis
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
Study Type
Interventional
2. Study Status
Record Verification Date
February 2022
Overall Recruitment Status
Completed
Study Start Date
July 6, 2019 (Actual)
Primary Completion Date
December 14, 2020 (Actual)
Study Completion Date
December 4, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Souzy Kamal
4. Oversight
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
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis Chronic Generalized Moderate
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
Masking
ParticipantOutcomes Assessor
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I (test)
Arm Type
Experimental
Arm Description
included twenty patients treated with SRP and intrapocket application of 2% lemongrass oil gel.
Arm Title
Group II (control)
Arm Type
Placebo Comparator
Arm Description
included twenty treated with SRP and intrapocket application of placebo gel.
Intervention Type
Drug
Intervention Name(s)
Cymbopogon citratus (lemongrass) oil gel
Intervention Description
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 Measure Information:
Title
Change in periodontal pocket depth
Description
the distance between the gingival margin and depth of probing
Time Frame
baseline and after 12 weeks
Title
Change in clinical attachment loss
Description
the distance between the CEJ and depth of probing
Time Frame
baseline and after 12 weeks
Title
Change in Matrix metalloproteinase-8 level
Description
Human Matrix metalloproteinase-8 level intracrevicularlly by collection of crevicular fluid sample
Time Frame
baseline and after 12 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Souzy K. Anwar, Ph.D
Organizational Affiliation
periodontology department. Faculty of dentistry. Alexandria university
Official's Role
Principal Investigator
Facility Information:
Facility Name
department of periodontology. Faculty of dentistry. Alexandria University
City
Alexandria
ZIP/Postal Code
21521
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all IPD that underlie results in a publication
Learn more about this trial
Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in the Treatment of Stage II Periodontitis
We'll reach out to this number within 24 hrs