- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT07060053
- Original Trial
The Effect of Oil Pulling on Oral Health-related Quality of Life
July 1, 2025 updated by: Christine Zürcher
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 Overview
Status
Completed
Conditions
Intervention / Treatment
Study Type
Interventional
Enrollment (Actual)
80
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
Tyrol
-
Innsbruck, Tyrol, Austria, 6020
- Medical University Innsbruck
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
- Adult
- Older Adult
Accepts Healthy Volunteers
Yes
Description
Inclusion Criteria:
- age ≥ 18 years
- contractual capability
- the presence of ≥ 10 teeth,
- community periodontal index of treatment needs (CPITN) grade 1 or 2
Exclusion Criteria:
- 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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Other
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: sesame oil
8 weeks oil pulling with 15 ml of sesame-based oil for 15min every morning
|
15min of oil pulling with 15ml sesame-based oil for 8 weeks
|
|
Other: distilled water
8 weeks rinsing with 15ml of distilled water for 15min every morning
|
15min rinsing with 15ml distilled water for 8 weeks
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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
|
first follow up after 4 weeks, full study duration 8 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
May 4, 2022
Primary Completion (Actual)
June 22, 2023
Study Completion (Actual)
June 22, 2023
Study Registration Dates
First Submitted
May 19, 2025
First Submitted That Met QC Criteria
July 1, 2025
First Posted (Actual)
July 11, 2025
Study Record Updates
Last Update Posted (Actual)
July 11, 2025
Last Update Submitted That Met QC Criteria
July 1, 2025
Last Verified
May 1, 2025
More Information
Terms related to this study
Other Study ID Numbers
- EK Nr 1117/2022
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
NO
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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