- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT06384638
Coconut Oil in Treatment of Periodontitis
April 24, 2024 updated by: Radwa Elsherif, Misr University for Science and Technology
Efficacy of Locally Delivered Coconut Oil in Management of Stage II and III Grade B Periodontitis. A Randomized Controlled Clinical Trial
Virgin Coconut Oil (VCO) is a vegetable oil extracted from coconut fleshcontains unsaturated fatty acids in the form of oleic acid and linoleic acid and flavonoids which function as anti-inflammatory.
Periodontitis is an inflammatory disease of the periodontal tissues with a high prevalence worldwide.
The main etiology of plaque periodontitis is biofilm containing colonies of pathogenic microorganisms.
The aim of the study is to evaluate and compare the effect of scaling and root debridement alone versus the use of topically applied coconut oil as adjunctive to scaling and root debridement in treatment of Stage II and III Grade B periodontitis.
Study Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
34
Phase
- 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
-
-
-
Giza, Egypt, 02
- Faculty of dentistry at MUST
-
-
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
- Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- patients age group >35 years without ant systemic disease
- Willing to take part in the study. Patients with more than 16 natural teeth and have test teeth with both mesial and distal neighboring teeth with periodontitis with clinical attachment loss >3 mm and radiographic percentage of bone loss/age ranged between 0.25 to 1.
- Patients with no history of allergies to coconut
Exclusion Criteria:
- smokers
- pregnant
- lactating women
- Teeth with both endodontic-periodontal lesion.
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: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: interventional
coconut oil as topical application as adjunctive to scaling and root debridement
|
topical application of coconut oil
scaling and debridement
|
|
Active Comparator: control
scaling and root debridement
|
scaling and debridement
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
clinical parameters
Time Frame: 3 months
|
clinical attachment loss
|
3 months
|
|
clinical parameters
Time Frame: 3 months
|
Probing depth
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Biological parameters
Time Frame: 3 months
|
Tumor necrosis factor alpha (TNF- α) levels by using ELISA.
|
3 months
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
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)
February 15, 2022
Primary Completion (Actual)
January 16, 2024
Study Completion (Actual)
February 9, 2024
Study Registration Dates
First Submitted
April 19, 2024
First Submitted That Met QC Criteria
April 24, 2024
First Posted (Actual)
April 25, 2024
Study Record Updates
Last Update Posted (Actual)
April 25, 2024
Last Update Submitted That Met QC Criteria
April 24, 2024
Last Verified
April 1, 2024
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- coconut periodontitis
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
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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