Oral Health Related Quality of LifeNCT07060053
The Effect of Oil Pulling on Oral Health-related Quality of Life
A study testing sesame oil and distilled water in people with Oral Health Related Quality of Life, run by Christine Zürcher at 1 site in Austria.
Trial summary
To date, there are no studies assessing the impact of mouth rinses on the oral health-related quality of life in healthy patients with gingivitis. Thus, this study aimed to assess the effect of oil pulling on the OHRQoL using the 14-item OHIP questionnaire (OHIP-14). Read more about this study
- Who is it for?
- Ages 18 to 99 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Health Related Quality of Life
- What is being tested?
- sesame oil and distilled water
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteAustria
- Study dates
- 4 May 2022to 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)
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
To date, there are no studies assessing the impact of mouth rinses on the oral health-related quality of life in healthy patients with gingivitis. Thus, this study aimed to assess the effect of oil pulling on the OHRQoL using the 14-item OHIP questionnaire (OHIP-14). The null hypothesis stated, that there would be no significant difference in OHIP-14 scores between individuals with gingivitis performing oil pulling with sesam-based oil and those using distilled water over an eight-week period.
- Conditions
- Oral Health Related Quality of Life
- Being tested
- sesame oil, distilled water
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-based 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 15 ml of sesame-based oil for 15min every morning Receives: Other: sesame oil |
| distilled water | Other | 8 weeks rinsing with 15ml of distilled water for 15min every morning Receives: Other: distilled water |
What is being measured
The primary outcome is the main question the study is designed to answer.
OHIP
The Oral Health Impact Profile-14 (OHIP-14), a questionnaire with 14 questions, evaluates the impact of oral health on quality of life across seven domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and speech limitation. Each of the 14 items is rated on a 5-point Likert scale, ranging from 0 (never) to 4 (very often). A total score of zero reflects the best possible oral health-related quality of life, while a score of 56 indicates the poorest. The validated German version of the questionnaire was used
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 posted11 Jul 2025
- Study start4 May 2022
- 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 Oral Health Related Quality of LifeStudies 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
- 80 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
- NCT07060053
- Sponsor's protocol ID
- EK Nr 1117/2022
- Status last verified
- May 2025
- First submitted
- 19 May 2025
- Last updated
- 11 Jul 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 11 Jul 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Oil Pulling on Oral Health-related Quality of Life
- ClinicalTrials.gov ID
- NCT07060053
- Acronym / sponsor ID
- EK Nr 1117/2022
- Conditions
- Oral Health Related Quality of Life
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Christine ZürcherUniversity, hospital or other
- Study start
- 4 May 2022 (actual)
- Primary completion
- 22 Jun 2023 (actual)
- Study completion
- 22 Jun 2023 (actual)
- First posted
- 11 Jul 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.
To date, there are no studies assessing the impact of mouth rinses on the oral health-related quality of life in healthy patients with gingivitis. Thus, this study aimed to assess the effect of oil pulling on the OHRQoL using the 14-item OHIP questionnaire (OHIP-14). The null hypothesis stated, that there would be no significant difference in OHIP-14 scores between individuals with gingivitis performing oil pulling with sesam-based oil and those using distilled water over an eight-week period.
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 oil | Experimental | Other: sesame oil8 weeks oil pulling with 15 ml of sesame-based oil for 15min every morning |
| distilled water | Other | Other: distilled water8 weeks rinsing with 15ml of distilled water for 15min every morning |
Who may qualify
- Ages
- 18 to 99 years
- Sex
- All
- Healthy volunteers
- 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-based oil for 8 weeks | Other | sesame oil |
| distilled water15min rinsing with 15ml distilled water for 8 weeks | Other | distilled water |
Primary outcome
OHIP
Time frame: first follow up after 4 weeks, full study duration 8 weeks
The Oral Health Impact Profile-14 (OHIP-14), a questionnaire with 14 questions, evaluates the impact of oral health on quality of life across seven domains: functional limitation, physical pain, psychological discomfort, physical disability, psychological disability, social disability, and speech limitation. Each of the 14 items is rated on a 5-point Likert scale, ranging from 0 (never) to 4 (very often). A total score of zero reflects the best possible oral health-related quality of life, while a score of 56 indicates the poorest. The validated German version of the questionnaire was used
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 11 Jul 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 oil and distilled water in people with Oral Health Related Quality of Life, 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 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 11 Jul 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?
OHIP (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 11 Jul 2025.