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

NCT05241509 | Completed Phase 4

• 1 other identifier: Lemon grass oil
• Study Type: interventional
• Target: 40
• Locations: 1 country
• Sites: 1

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.

Conditions

Periodontitis Chronic Generalized Moderate

Outcome Measures

Primary Outcomes (3)

• Change in periodontal pocket depth

  the distance between the gingival margin and depth of probing

  baseline and after 12 weeks

• Change in clinical attachment loss

  the distance between the CEJ and depth of probing

  baseline and after 12 weeks

• Change in Matrix metalloproteinase-8 level

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

  baseline and after 12 weeks

Study Arms (2)

Group I (test)

EXPERIMENTAL

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

Drug: Cymbopogon citratus (lemongrass) oil gel

Group II (control)

PLACEBO COMPARATOR

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

Drug: Cymbopogon citratus (lemongrass) oil gel

Interventions

Cymbopogon citratus (lemongrass) oil gel DRUG

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

Group I (test); Group II (control)

Eligibility Criteria

• Age: 25 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Souzy Kamal: lead

Study Sites (1)

department of periodontology. Faculty of dentistry. Alexandria University

Alexandria, 21521, Egypt

Location

Study Officials

• Souzy K. Anwar, Ph.D

  periodontology department. Faculty of dentistry. Alexandria university

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: lecturer of oral medicine, periodontology, oral diagnosis and radiology

Study Record Dates

• First Submitted: January 27, 2022
• First Posted: February 15, 2022
• Study Start: July 6, 2019
• Primary Completion: December 14, 2020
• Study Completion: December 4, 2021
• Last Updated: February 15, 2022

Record last verified: 2022-02

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, ICF

Locations

EG (1)