Periodontal DiseasesPhase 1NCT06384638
Coconut Oil in Treatment of Periodontitis
A Phase 1 study testing topical application of coconut oil and scaling and debridement in people with Periodontal Diseases, run by Misr University for Science and Technology at 1 site in Egypt.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 35 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Periodontal Diseases
- What is being tested?
- topical application of coconut oil and scaling and debridement
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 34 participants
- Where
- 1 siteEgypt
- Study dates
- 15 Feb 2022to 9 Feb 2024
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 35 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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
Who cannot join
- smokers
- pregnant
- lactating women
- Teeth with both endodontic-periodontal lesion.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
- Conditions
- Periodontal Diseases
- Being tested
- topical application of coconut oil, scaling and debridement
- Keywords
- Periodontitis, coconut oil, scaling and debridement
- Medical subject headings
- Periodontal Diseases, Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
topical application of coconut oilBiological
topical application of coconut oil
scaling and debridementOther
scaling and debridement
| Study group | Role | What they receive |
|---|---|---|
| interventional | Active comparator | coconut oil as topical application as adjunctive to scaling and root debridement Receives: Biological: topical application of coconut oil; Other: scaling and debridement |
| control | Active comparator | scaling and root debridement Receives: Other: scaling and debridement |
What is being measured
The primary outcome is the main question the study is designed to answer.
clinical parameters
clinical attachment loss
Measured: 3 months
clinical parameters
Probing depth
Measured: 3 months
Secondary outcomes (1)
Biological parameters
Tumor necrosis factor alpha (TNF- α) levels by using ELISA.
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Apr 2024
- Study start15 Feb 2022
- Primary completion16 Jan 2024
- Study completion9 Feb 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontal DiseasesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Care provider, Outcomes assessor
- Enrolment
- 34 participants (actual)
Sponsor and investigators
- Lead sponsor
- Misr University for Science and Technology
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Radwa Elsherif, Misr University for Science and Technology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06384638
- Sponsor's protocol ID
- coconut periodontitis
- Status last verified
- Apr 2024
- First submitted
- 19 Apr 2024
- Last updated
- 25 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Locally Delivered Coconut Oil in Management of Stage II and III Grade B Periodontitis. A Randomized Controlled Clinical Trial
- ClinicalTrials.gov ID
- NCT06384638
- Acronym / sponsor ID
- coconut periodontitis
- Conditions
- Periodontal Diseases
- Keywords
- Periodontitis, coconut oil, scaling and debridement
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 34 participants (actual)
- Lead sponsor
- Misr University for Science and TechnologyUniversity, hospital or other
- Study start
- 15 Feb 2022 (actual)
- Primary completion
- 16 Jan 2024 (actual)
- Study completion
- 9 Feb 2024 (actual)
- First posted
- 25 Apr 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (care provider, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| interventional | Active comparator | Biological: topical application of coconut oil, Other: scaling and debridementcoconut oil as topical application as adjunctive to scaling and root debridement |
| control | Active comparator | Other: scaling and debridementscaling and root debridement |
Who may qualify
- Ages
- 35 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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
Key exclusion criteria (4 listed)
- smokers
- pregnant
- lactating women
- Teeth with both endodontic-periodontal lesion.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| topical application of coconut oiltopical application of coconut oil | Biological | interventional |
| scaling and debridementscaling and debridement | Other | control, interventional |
Primary outcome
clinical parameters
Time frame: 3 months
clinical attachment loss
clinical parameters
Time frame: 3 months
Probing depth
1 secondary outcome
Biological parameters
Time frame: 3 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Apr 2024.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing topical application of coconut oil and scaling and debridement in people with Periodontal Diseases, run by Misr University for Science and Technology at 1 site in Egypt.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 Apr 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
clinical parameters (time frame: 3 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2024.