Skip to main content
OpenTrials
Completed

NCT Number: NCT04605289

Levels of Matrix Metalloproteinase-8 After Intrapocket Treatment 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).

Completed

Looking for future studies?

Notify Me

Key information

Conditions

Periodontitis Mouth Diseases Periodontal Diseases Stomatognathic Diseases

Age range

25 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1 / Phase 2

Primary location

Alexandria University

Alexandria, Egypt

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

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

Exclusion criteria

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

Treatment and study plan

lemongrass essential oil gel

Drug

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

Placebo

Drug

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

Scaling and Root Planing

Procedure

Conventional mechanical treatment by ultra-sonic scalers

Primary outcomes

  1. Changes of clinical attachment and periodontal probing pocket

    Time frame: at baseline and twelve weeks from intervention.

    Millimeters (mm)

Secondary outcomes

  1. GCF concentration of MMP-8

    Time frame: at baseline, one week, and twelve weeks from intervention.

    pg/ml

Sponsors and collaborators

Lead sponsor

Alexandria University

Other

Registry information

Official study title

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

Acronym: MMP-8

Important dates

Study start
2020
Primary completion
2020
Study completion
2020
First posted
Oct 28, 2020
Registry last updated
Jan 12, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Related clinical trials

Published trials that share one or more normalized conditions with this study.