Periodontitis, AdultEarly Phase 1NCT07175090
Evaluation of Coconut Oil Mouth Rinse on Periodontal Parameters
A Early Phase 1 study testing Coconut oil in people with Periodontitis, Adult and Mouthwash, run by University of Pristina at 1 site in Kosovo.
Trial summary
This study was based on testing a new natural mouthwash with coconut oil and xylitol as active agents to a placebo rinse on new periodontal parameters Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Periodontitis, Adult, Mouthwash
- What is being tested?
- Coconut oil
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 120 participants
- Where
- 1 siteKosovo
- Study dates
- 1 Jun 2024to 1 May 2025
- Phase
- Early 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 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Periodontitis grade I, II, III
Who cannot join
- less than 20 teeth
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of a Novel Coconut Oil Mouth Rinse on Periodontal Parameters: A Randomized Controlled Trial
This study was based on testing a new natural mouthwash with coconut oil and xylitol as active agents to a placebo rinse on new periodontal parameters
- Conditions
- Periodontitis, Adult, Mouthwash
- Being tested
- Coconut oil, Placebo
- Medical subject headings
- Chronic Periodontitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Coconut oilCombination product
The rinse is used three times a day during three weeks
PlaceboOther
Inactive ingredients with same taste and colour
| Study group | Role | What they receive |
|---|---|---|
| Group A | Placebo comparator | Not described Receives: Other: Placebo |
| Group B | Active comparator | Not described Receives: Combination Product: Coconut oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
Improvement of gingival appearance
The gingival index will be assessed before and after mouthrinse use
Measured: Three weeks of mouthrinse use
Secondary outcomes (1)
Gingival bleeding
The presence of gingival bleeding will be assessed before and after mouthrinse use
Measured: Three weeks after mouthrinse use
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted16 Sep 2025
- Study start1 Jun 2024
- Primary completion1 Feb 2025
- Study completion1 May 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Periodontitis, AdultStudies 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
- Early Phase 1
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 120 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Pristina
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Kastriot Meqa, University of Pristina
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07175090
- Sponsor's protocol ID
- 312/3
- Status last verified
- Apr 2025
- First submitted
- 4 Sep 2025
- Last updated
- 16 Sep 2025
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 16 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of a Novel Coconut Oil Mouth Rinse on Periodontal Parameters: A Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07175090
- Acronym / sponsor ID
- 312/3
- Conditions
- Periodontitis, Adult, Mouthwash
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 120 participants (actual)
- Lead sponsor
- University of PristinaUniversity, hospital or other
- Study start
- 1 Jun 2024 (actual)
- Primary completion
- 1 Feb 2025 (actual)
- Study completion
- 1 May 2025 (actual)
- First posted
- 16 Sep 2025 (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.
This study was based on testing a new natural mouthwash with coconut oil and xylitol as active agents to a placebo rinse on new periodontal parameters
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group A | Placebo comparator | Other: Placebo |
| Group B | Active comparator | Combination Product: Coconut oil |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Periodontitis grade I, II, III
Key exclusion criteria (1 listed)
- less than 20 teeth
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 |
|---|---|---|
| Coconut oilThe rinse is used three times a day during three weeks | Combination product | Group B |
| PlaceboInactive ingredients with same taste and colour | Other | Group A |
Primary outcome
Improvement of gingival appearance
Time frame: Three weeks of mouthrinse use
The gingival index will be assessed before and after mouthrinse use
1 secondary outcome
Gingival bleeding
Time frame: Three weeks after mouthrinse use
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 16 Sep 2025.
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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 Early Phase 1 study testing Coconut oil in people with Periodontitis, Adult and Mouthwash, run by University of Pristina at 1 site in Kosovo.
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 1 inclusion and 1 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 16 Sep 2025. 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 Kosovo. 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. Some participants in this study may receive a placebo. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Improvement of gingival appearance (time frame: Three weeks of mouthrinse use). 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 16 Sep 2025.