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

NCT ID: NCT05241509

Last Updated: 2022-02-15

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE4

Total Enrollment

40 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-07-06

Study Completion Date

2021-12-04

Brief Summary

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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.

Detailed Description

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Conditions

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Periodontitis Chronic Generalized Moderate

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Outcome Assessors

Study Groups

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Group I (test)

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

Group Type EXPERIMENTAL

Cymbopogon citratus (lemongrass) oil gel

Intervention Type 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 II (control)

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

Group Type PLACEBO_COMPARATOR

Cymbopogon citratus (lemongrass) oil gel

Intervention Type 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

Interventions

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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

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

25 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Souzy Kamal

OTHER

Sponsor Role lead

Responsible Party

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Souzy Kamal

lecturer of oral medicine, periodontology, oral diagnosis and radiology

Responsibility Role SPONSOR_INVESTIGATOR

Principal Investigators

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Souzy K. Anwar, Ph.D

Role: PRINCIPAL_INVESTIGATOR

periodontology department. Faculty of dentistry. Alexandria university

Locations

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department of periodontology. Faculty of dentistry. Alexandria University

Alexandria, , Egypt

Site Status

Countries

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Egypt

Other Identifiers

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Lemon grass oil

Identifier Type: -

Identifier Source: org_study_id

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