Levels of Matrix Metalloproteinase-8 After Intrapocket Treatment in Moderate Periodontitis Patients. (MMP-8)
Primary Purpose
Periodontitis
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
lemongrass essential oil gel
Placebo
Scaling and root planing
Sponsored by
About this trial
This is an interventional treatment trial for Periodontitis
Eligibility Criteria
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.
Sites / Locations
- Alexandria University
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
Group I (study group)
Group II (control group)
Arm Description
Scaling and root planing + intra-pocket application of 2% Cymbopogon citratus (lemon-grass) gel
Scaling and root planing +intra-pocket application of placebo gel
Outcomes
Primary Outcome Measures
Changes of clinical attachment and periodontal probing pocket
Millimeters (mm)
Secondary Outcome Measures
GCF concentration of MMP-8
pg/ml
Full Information
NCT ID
NCT04605289
First Posted
October 15, 2020
Last Updated
January 11, 2021
Sponsor
Alexandria University
1. Study Identification
Unique Protocol Identification Number
NCT04605289
Brief Title
Levels of Matrix Metalloproteinase-8 After Intrapocket Treatment in Moderate Periodontitis Patients.
Acronym
MMP-8
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
Study Type
Interventional
2. Study Status
Record Verification Date
January 2021
Overall Recruitment Status
Completed
Study Start Date
January 13, 2020 (Actual)
Primary Completion Date
August 31, 2020 (Actual)
Study Completion Date
October 14, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Alexandria University
4. Oversight
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
Data Monitoring Committee
Yes
5. 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).
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1, Phase 2
Interventional Study Model
Parallel Assignment
Model Description
-Cymbopogon citratus oil gel /-Placebo gel. will be intrapocket application as an adjunctive treatment to conventional therapy
Masking
Participant
Allocation
Randomized
Enrollment
40 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group I (study group)
Arm Type
Experimental
Arm Description
Scaling and root planing + intra-pocket application of 2% Cymbopogon citratus (lemon-grass) gel
Arm Title
Group II (control group)
Arm Type
Placebo Comparator
Arm Description
Scaling and root planing +intra-pocket application of placebo gel
Intervention Type
Drug
Intervention Name(s)
lemongrass essential oil gel
Other Intervention Name(s)
Cymbopogon citratus oil gel
Intervention Description
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.
Intervention Type
Drug
Intervention Name(s)
Placebo
Other Intervention Name(s)
Carbopol®-Based pH-Sensitive gel
Intervention Description
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.
Intervention Type
Procedure
Intervention Name(s)
Scaling and root planing
Intervention Description
Conventional mechanical treatment by ultra-sonic scalers
Primary Outcome Measure Information:
Title
Changes of clinical attachment and periodontal probing pocket
Description
Millimeters (mm)
Time Frame
at baseline and twelve weeks from intervention.
Secondary Outcome Measure Information:
Title
GCF concentration of MMP-8
Description
pg/ml
Time Frame
at baseline, one week, and twelve weeks from intervention.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Nadein E Sharif
Organizational Affiliation
Alexandria University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Alexandria University
City
Alexandria
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
all collected IPD
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Levels of Matrix Metalloproteinase-8 After Intrapocket Treatment in Moderate Periodontitis Patients.
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