Levels of Matrix Metalloproteinase-8 After Intrapocket Treatment in Moderate Periodontitis Patients.
NCT ID: NCT04605289
Last Updated: 2021-01-12
Study Results
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Basic Information
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COMPLETED
PHASE1/PHASE2
40 participants
INTERVENTIONAL
2020-01-13
2020-10-14
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Group I (study group)
Scaling and root planing + intra-pocket application of 2% Cymbopogon citratus (lemon-grass) gel
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.
Scaling and root planing
Conventional mechanical treatment by ultra-sonic scalers
Group II (control group)
Scaling and root planing +intra-pocket application of placebo gel
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.
Scaling and root planing
Conventional mechanical treatment by ultra-sonic scalers
Interventions
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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.
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.
Scaling and root planing
Conventional mechanical treatment by ultra-sonic scalers
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
25 Years
45 Years
ALL
No
Sponsors
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Alexandria University
OTHER
Responsible Party
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Nadein El Sharif
A student of Master's degree
Principal Investigators
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Nadein E Sharif
Role: PRINCIPAL_INVESTIGATOR
Alexandria University
Locations
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Alexandria University
Alexandria, , Egypt
Countries
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References
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Provided Documents
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Document Type: Study Protocol and Informed Consent Form
Other Identifiers
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17102019
Identifier Type: -
Identifier Source: org_study_id
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