Dental PlaqueNCT06841380
Plaque Reduction Sesame-based Oil
A study testing sesame-based oil and distilled water in people with Dental Plaque and Gingivitis, run by Christine Zürcher 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-based oil compared to rinsing with distilled water? Participants will rinse with 15 ml of their… Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Dental Plaque, Gingivitis, Oral Microbial Colonization
- What is being tested?
- sesame-based 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
- 25 Apr 2023to 22 Jun 2023
- 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
- Healthy volunteers accepted
- 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) 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-Based 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-based 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-based 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-based 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-based oilOther
15min of oil pulling with 15ml sesame-based oil for 8 weeks
distilled waterOther
15min rinsing with 15ml distilled water for 8 weeks
| Study group | Role | What they receive |
|---|---|---|
| sesame-based oil | Experimental | 8 weeks oil pulling with sesame-based oil 15ml 15min every morning Receives: Other: sesame-based 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 (3)
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
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Feb 2025
- Study start25 Apr 2023
- Primary completion22 Jun 2023
- Study completion22 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Christine Zürcher
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Christine Zürcher, Medical University Innsbruck
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06841380
- Sponsor's protocol ID
- 1117/2022
- Status last verified
- Feb 2025
- First submitted
- 18 Feb 2025
- Last updated
- 24 Feb 2025
- Results posted
- No
- Data monitoring committee
- No
- 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 24 Feb 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Plaque Reducing Efficacy of Oil Pulling with Sesame-Based Oil. a Randomized-controlled Clinical Study
- ClinicalTrials.gov ID
- NCT06841380
- Acronym / sponsor ID
- 1117/2022
- Conditions
- Dental Plaque, Gingivitis, Oral Microbial Colonization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Christine ZürcherUniversity, hospital or other
- Study start
- 25 Apr 2023 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 24 Feb 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.
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-based 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-based oil against distilled water to see if there is a difference in the plaque reducing effect.
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| sesame-based oil | Experimental | Other: sesame-based oil8 weeks oil pulling with sesame-based 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
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 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 (1 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 allergy against sesame(oil) 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
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-based oil15min of oil pulling with 15ml sesame-based oil for 8 weeks | Other | sesame-based 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
3 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
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 24 Feb 2025.
- 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 study testing sesame-based oil and distilled water in people with Dental Plaque and Gingivitis, run by Christine Zürcher 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 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 24 Feb 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 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?
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 24 Feb 2025.