Levels of Matrix Metalloproteinase-8 After Intrapocket Treatment in Moderate Periodontitis Patients. (MMP-8)

January 11, 2021 updated by: Nadein El Sharif, Alexandria University

Biochemical Efficacy of Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in Moderate Periodontitis Patients

Using local delivery drugs as adjunctive to scaling and root planing and evaluating gingival crevicular fluid (GCF) biological molecular markers (MMP-8).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Study sample and setting A sample size of twenty patients per group (number of groups = 2) (total sample size = 40 patients) is the sufficient required sample as statistically significant with 80% power. The sample size was calculated using g power version 3.1.9.2. patients will be recruited from the outpatient clinic of the Department of Oral Medicine, Periodontology, Diagnosis and Oral Radiology. Faculty of Dentistry, Alexandria University.

Treatment will be in accordance with the principles of the modified Helsinki code for human clinical studies (2013).

The clinical study will be conducted following the ethical guidelines for conduct of research on human subjects, by the Faculty of Dentistry, Alexandria University (IRB NO:00010556 - IORG 0008839).

Data management and statistical analysis The data will be processed and analysed using statistical package for social sciences program SPSS (20.0) software*. The study will include descriptive and analytical data. A P-value of less than 0.05 will be considered statistically significant.

Study Type

Interventional

Enrollment (Actual)

40

Phase

  • Phase 2
  • Phase 1

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Egypt
      • Alexandria, Egypt
        • Alexandria University

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

21 years to 41 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  1. Patients of both sexes having moderate periodontitis (stage II), CAL 3-4mm.
  2. Patients' age between 25 and 45 years old.
  3. Systemically healthy patients.
  4. No history of periodontal therapy (surgical and non-surgical) or taken any antibiotic therapy for the past six months.

Exclusion Criteria:

  1. History of smoking.
  2. Patients having previous adverse reaction to the products (or similar products) used in this study.
  3. Grade C category that has rapid rate of progression.
  4. Pregnant and lactating women.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Group I (study group)
Scaling and root planing + intra-pocket application of 2% Cymbopogon citratus (lemon-grass) gel
Drug: lemongrass essential oil gel

The lemongrass oil gel will be administered by means of a syringe with a bent, blunt-end needle. The needle will be carefully inserted into the periodontal pocket and the gel will be applied in the test sites in a gentle probing manner, attempting to fill the full extent of the pocket. The gel will be applied up to the gingival margin and the excess gel will be removed with sterile gauze.

Periodontal dressing will be applied after the delivery of the drug, and they will be also asked not to eat for thirty minutes.

After placement of the gel in situ, patients will be instructed to follow strict oral hygiene protocol and not chew hard or sticky foods at the gel placement sites for rest of the week.

Other Names:
  • Cymbopogon citratus oil gel
Procedure: Scaling and root planing
Conventional mechanical treatment by ultra-sonic scalers
Placebo Comparator: Group II (control group)
Scaling and root planing +intra-pocket application of placebo gel
Procedure: Scaling and root planing
Conventional mechanical treatment by ultra-sonic scalers
Drug: Placebo

The placebo will be administered by means of a syringe with a bent, blunt-end needle. The needle will be carefully inserted into the periodontal pocket and the gel will be applied in the test sites in a gentle probing manner, attempting to fill the full extent of the pocket. The gel will be applied up to the gingival margin and the excess gel will be removed with sterile gauze.

Periodontal dressing will be applied after the delivery of the drug, and they will be also asked not to eat for thirty minutes.

After placement of the gel in situ, patients will be instructed to follow strict oral hygiene protocol and not chew hard or sticky foods at the gel placement sites for rest of the week.

Other Names:
  • Carbopol®-Based pH-Sensitive gel

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes of clinical attachment and periodontal probing pocket
Time Frame: at baseline and twelve weeks from intervention.
Millimeters (mm)
at baseline and twelve weeks from intervention.

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GCF concentration of MMP-8
Time Frame: at baseline, one week, and twelve weeks from intervention.
pg/ml
at baseline, one week, and twelve weeks from intervention.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Alexandria University

Investigators

  • Principal Investigator: Nadein E Sharif, Alexandria University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 13, 2020

Primary Completion (Actual)

August 31, 2020

Study Completion (Actual)

October 14, 2020

Study Registration Dates

First Submitted

October 15, 2020

First Submitted That Met QC Criteria

October 21, 2020

First Posted (Actual)

October 28, 2020

Study Record Updates

Last Update Posted (Actual)

January 12, 2021

Last Update Submitted That Met QC Criteria

January 11, 2021

Last Verified

January 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 17102019

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

IPD Plan Description

all collected IPD

IPD Sharing Supporting Information Type

  • Study Protocol
  • Statistical Analysis Plan (SAP)

Drug and device information, study documents

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.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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