Dental PlaqueNCT06327841
Plaque Reduction Sesame Oil
A study testing sesame oil and distilled water in people with Dental Plaque and Gingivitis, run by Medical University Innsbruck at 1 site in Austria.
Trial summary
The goal of this clinical trials to learn about potential additives in reducing dental plaque. The main questions it aims to answer is: is there a difference in the plaque reducing effect of oil pulling with sesame oil compared to rinsing with distilled water? Participants will rinse with 15 ml of their allocated… Read more about this study
- Who is it for?
- Ages 18 to 99 years
- Conditions the study is for
- Dental Plaque, Gingivitis, Oral Microbial Colonization
- What is being tested?
- sesame oil and distilled water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 40 participants
- Where
- 1 siteAustria
- Study dates
- 21 Jun 2022to 18 Aug 2022
- Phase
- Interventional
- 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 to 99 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- age ≥ 18 years
- contractual capability
- the presence of ≥ 10 teeth,
- community periodontal index of treatment needs (CPITN) grade 1 or 2
Who cannot join
- missing consent
- community periodontal index of treatment needs (CPITN) grade 0, 3 or 4
- pregnancy or breastfeeding
- systemic diseases or conditions that are associated with an increased risk of infection or necessitate concomitant antibiotic therapy with dental treatment
- mental and behavioral disorders that impede (verbal) communication
- allergy against sesame(oil)
Show all 13Show fewer
- intake of antibiotics 6 months prior to or during study duration
- intake of medication potentially influencing gingival inflammation or bleeding (e.g. anticoagulants, cortisone)
- infectious diseases (e.g. HIV, hepatitis B or C)
- fixed orthodontic appliances
- ongoing oil pulling or mouth rinsing
- adult guardianship
- insufficient nasal breathing
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Plaque Reducing Efficacy of Oil Pulling With Sesame Oil. A Randomized-controlled Clinical Study
The goal of this clinical trials to learn about potential additives in reducing dental plaque. The main questions it aims to answer is:
- is there a difference in the plaque reducing effect of oil pulling with sesame oil compared to rinsing with distilled water? Participants will rinse with 15 ml of their allocated liquid for 15 min every morning for 8 weeks.
Researchers will compare sesame oil against distilled water to see if there is a difference in the plaque reducing effect.
- Conditions
- Dental Plaque, Gingivitis, Oral Microbial Colonization
- Being tested
- sesame oil, distilled water
- Medical subject headings
- Dental Plaque, Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
sesame oilOther
15min of oil pulling with 15ml sesame oil for 8 weeks
distilled waterOther
15min rinsing with 15ml distilled water for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| sesame oil | Experimental | 8 weeks oil pulling with sesame oil 15ml 15min every morning Receives: Other: sesame oil |
| distilled water | Other | 8 weeks rinsing with distilled water 15ml 15min every morning Receives: Other: distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Rustogi Modified Navy Plaque Index (RMNPI)
Measured: first follow up after 4 weeks, full study duration 8 weeks
Secondary outcomes (4)
Gingival Index (GI)
Measured: first follow up after 4 weeks, full study duration 8 weeks
microbial analysis
Measured: first follow up after 4 weeks, full study duration 8 weeks
Oral Health Impact Profile (OHIP)
Measured: first follow up after 4 weeks, full study duration 8 weeks
Interview halitosis, xerostomia
Measured: first follow up after 4 weeks, full study duration 8 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Mar 2024
- Study start21 Jun 2022
- Primary completion18 Aug 2022
- Study completion18 Aug 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Dental PlaqueStudies 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Medical University Innsbruck
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Christine Zürcher, Medical University Innsbruck
- Investigators
- Ines Kapferer-Seebacher, Study chair, Medical University InnsbruckMarkus Nagl, Study chair, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06327841
- Sponsor's protocol ID
- EK 1117/2022
- Status last verified
- Mar 2024
- First submitted
- 18 Mar 2024
- Last updated
- 25 Mar 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zurcher C, Vukoje K, Kleiner EM, Kuster SM, Jager-Larcher LK, Heller I, Eick S, Nagl M, Kapferer-Seebacher I. The plaque reducing efficacy of oil pulling with sesame oil: a randomized-controlled clinical study. Clin Oral Investig. 2025 Jan 9;29(1):53. doi: 10.1007/s00784-024-06134-y.
PubMed 39786483
Study at a glance
From the registry record, last updated by the sponsor on 25 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Plaque Reducing Efficacy of Oil Pulling With Sesame Oil. A Randomized-controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06327841
- Acronym / sponsor ID
- EK 1117/2022
- Conditions
- Dental Plaque, Gingivitis, Oral Microbial Colonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Medical University InnsbruckUniversity, hospital or other
- Study start
- 21 Jun 2022 (actual)
- Primary completion
- 18 Aug 2022 (actual)
- Study completion
- 18 Aug 2022 (actual)
- First posted
- 25 Mar 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.
The goal of this clinical trials to learn about potential additives in reducing dental plaque. The main questions it aims to answer is:
- is there a difference in the plaque reducing effect of oil pulling with sesame oil compared to rinsing with distilled water? Participants will rinse with 15 ml of their allocated liquid for 15 min every morning for 8 weeks.
Researchers will compare sesame oil against distilled water to see if there is a difference in the plaque reducing effect.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sesame oil | Experimental | Other: sesame oil8 weeks oil pulling with sesame oil 15ml 15min every morning |
| distilled water | Other | Other: distilled water8 weeks rinsing with distilled water 15ml 15min every morning |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- age ≥ 18 years
- contractual capability
- the presence of ≥ 10 teeth,
- community periodontal index of treatment needs (CPITN) grade 1 or 2
Key exclusion criteria (13 listed)
- missing consent
- community periodontal index of treatment needs (CPITN) grade 0, 3 or 4
- pregnancy or breastfeeding
- systemic diseases or conditions that are associated with an increased risk of infection or necessitate concomitant antibiotic therapy with dental treatment
- mental and behavioral disorders that impede (verbal) communication
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 |
|---|---|---|
| sesame oil15min of oil pulling with 15ml sesame oil for 8 weeks | Other | sesame oil |
| distilled water15min rinsing with 15ml distilled water for 8 weeks | Other | distilled water |
Primary outcome
Rustogi Modified Navy Plaque Index (RMNPI)
Time frame: first follow up after 4 weeks, full study duration 8 weeks
4 secondary outcomes
Gingival Index (GI)
Time frame: first follow up after 4 weeks, full study duration 8 weeks
microbial analysis
Time frame: first follow up after 4 weeks, full study duration 8 weeks
Oral Health Impact Profile (OHIP)
Time frame: first follow up after 4 weeks, full study duration 8 weeks
Interview halitosis, xerostomia
Time frame: first follow up after 4 weeks, full study duration 8 weeks
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 Mar 2024.
- Derived from this study: PubMed 39786483Zurcher C, Vukoje K, Kleiner EM, Kuster SM, Jager-Larcher LK, Heller I, Eick S, Nagl M, Kapferer-Seebacher I. The plaque reducing efficacy of oil pulling with sesame oil: a randomized-controlled clinical study. Clin Oral Investig. 2025 Jan 9;29(1):53. doi: 10.1007/s00784-024-06134-y.
- 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.
Ines Kapferer-Seebacher study chair
Medical University Innsbruck
Markus Nagl study chair
Medical University Innsbruck
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing sesame oil and distilled water in people with Dental Plaque and Gingivitis, run by Medical University Innsbruck at 1 site in Austria.
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 4 inclusion and 13 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 Mar 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 Austria. 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.
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?
Rustogi Modified Navy Plaque Index (RMNPI) (time frame: first follow up after 4 weeks, full study duration 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06327841, which also lists 1 linked publication.
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 Mar 2024.