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

Sponsor
Alexandria University (Other)
Overall Status
Completed
CT.gov ID
NCT04605289
Collaborator
(none)
40
Enrollment
1
Location
2
Arms
9
Actual Duration (Months)
4.4
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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

Condition or Disease Intervention/Treatment Phase
  • Drug: lemongrass essential oil gel
  • Drug: Placebo
  • Procedure: Scaling and root planing
 Phase 1/Phase 2

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 Design

Study Type:
Interventional
Actual Enrollment :
40 participants
Allocation:
Randomized
Intervention Model:
Parallel Assignment
Intervention Model Description:
-Cymbopogon citratus oil gel /-Placebo gel. will be intrapocket application as an adjunctive treatment to conventional therapy-Cymbopogon citratus oil gel /-Placebo gel. will be intrapocket application as an adjunctive treatment to conventional therapy
Masking:
Single (Participant)
Primary Purpose:
Treatment
Official Title:
Biochemical Efficacy of Cymbopogon Citratus Gel as Local Drug Delivery Agent in Reducing Matrix Metalloproteinase-8 Levels Intra-crevicularly in Moderate Periodontitis Patients
Actual Study Start Date :
Jan 13, 2020
Actual Primary Completion Date :
Aug 31, 2020
Actual Study Completion Date :
Oct 14, 2020

Arms and Interventions

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

    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

    • Procedure: Scaling and root planing
    Conventional mechanical treatment by ultra-sonic scalers

    Outcome Measures

    Primary Outcome Measures

    1. Changes of clinical attachment and periodontal probing pocket [at baseline and twelve weeks from intervention.]

      Millimeters (mm)

    Secondary Outcome Measures

    1. GCF concentration of MMP-8 [at baseline, one week, and twelve weeks from intervention.]

      pg/ml

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    25 Years to 45 Years
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    No
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Alexandria University Alexandria Egypt

    Sponsors and Collaborators

    • Alexandria University

    Investigators

    • Principal Investigator: Nadein E Sharif, Alexandria University

    Study Documents (Full-Text)

    More Information

    Publications

    Responsible Party:
    Nadein El Sharif, A student of Master's degree, Alexandria University
    ClinicalTrials.gov Identifier:
    NCT04605289
    Other Study ID Numbers:
    • 17102019
    First Posted:
    Oct 28, 2020
    Last Update Posted:
    Jan 12, 2021
    Last Verified:
    Jan 1, 2021
    Individual Participant Data (IPD) Sharing Statement:
    Yes
    Plan to Share IPD:
    Yes
    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
    Additional relevant MeSH terms:
    Periodontitis

    Study Results

    No Results Posted as of Jan 12, 2021