Clinical trial NCT05241509: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Periodontitis Chronic Generalized Moderate
Lead sponsor: Alexandria University
Sponsor class: OTHER
First posted: 2022-02-15
Enrollment: 40
Sex: ALL
Minimum age (years): 25
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.


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

Primary outcomes:
measure: Change in periodontal pocket depth
timeFrame: baseline and after 12 weeks
measure: Change in clinical attachment loss
timeFrame: baseline and after 12 weeks
measure: Change in Matrix metalloproteinase-8 level
timeFrame: baseline and after 12 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Alexandria
country: Egypt
facility: department of periodontology. Faculty of dentistry. Alexandria University
Study officials:
affiliation: periodontology department. Faculty of dentistry. Alexandria university
name: Souzy K. Anwar, Ph.D
role: PRINCIPAL_INVESTIGATOR
References: