The Effect of Oil Pulling on Oral Health-related Quality of Life

NCT07060053 | Completed

• 1 other identifier: EK Nr 1117/2022
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

Brief 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). 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

Outcome Measures

Primary Outcomes (1)

• 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

  first follow up after 4 weeks, full study duration 8 weeks

Study Arms (2)

sesame oil

EXPERIMENTAL

8 weeks oil pulling with 15 ml of sesame-based oil for 15min every morning

Other: sesame oil

distilled water

OTHER

8 weeks rinsing with 15ml of distilled water for 15min every morning

Other: distilled water

Interventions

sesame oil OTHER

15min of oil pulling with 15ml sesame-based oil for 8 weeks

sesame oil

distilled water OTHER

15min rinsing with 15ml distilled water for 8 weeks

distilled water

Eligibility Criteria

• Age: 18 Years - 99 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• age ≥ 18 years
• contractual capability
• the presence of ≥ 10 teeth,
• community periodontal index of treatment needs (CPITN) grade 1 or 2

You may not qualify if:

• 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

Sponsors & Collaborators

• Christine Zürcher: lead

Study Sites (1)

Medical University Innsbruck

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Interventions

Sesame Oil

Intervention Hierarchy (Ancestors)

Dietary Fats, Unsaturated; Dietary Fats; Fats; Lipids; Fats, Unsaturated; Plant Oils; Oils; Plant Preparations; Biological Products; Complex Mixtures; Food; Diet, Food, and Nutrition; Physiological Phenomena; Food and Beverages

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Dr.

Study Record Dates

• First Submitted: May 19, 2025
• First Posted: July 11, 2025
• Study Start: May 4, 2022
• Primary Completion: June 22, 2023
• Study Completion: June 22, 2023
• Last Updated: July 11, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)