NCT06327841

Brief 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 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
40

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

June 21, 2022

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 18, 2022

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 18, 2022

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

March 18, 2024

Completed
7 days until next milestone

First Posted

Study publicly available on registry

March 25, 2024

Completed
Last Updated

March 25, 2024

Status Verified

March 1, 2024

Enrollment Period

2 months

First QC Date

March 18, 2024

Last Update Submit

March 22, 2024

Conditions

Dental PlaqueGingivitisOral Microbial Colonization

Outcome Measures

Primary Outcomes (1)

  • Rustogi Modified Navy Plaque Index (RMNPI)

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

Secondary Outcomes (4)

  • Gingival Index (GI)

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

  • microbial analysis

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

  • Oral Health Impact Profile (OHIP)

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

  • Interview halitosis, xerostomia

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

Study Arms (2)

sesame oil

EXPERIMENTAL

8 weeks oil pulling with sesame oil 15ml 15min every morning

Other: sesame oil

distilled water

OTHER

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

Other: distilled water

Interventions

sesame oilOTHER

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

sesame oil
distilled waterOTHER

15min rinsing with 15ml distilled water for 8 weeks

distilled water

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Medical University

Innsbruck, Tyrol, 6020, Austria

Location

Related Publications (1)

  • 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.

    PMID: 39786483DERIVED

MeSH Terms

Conditions

Dental PlaqueGingivitis

Interventions

Sesame Oil

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesPeriodontal DiseasesMouth Diseases

Intervention Hierarchy (Ancestors)

Dietary Fats, UnsaturatedDietary FatsFatsLipidsFats, UnsaturatedPlant OilsOilsPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Officials

  • Ines Kapferer-Seebacher

    Medical University Innsbruck

    STUDY CHAIR

  • Markus Nagl

    Medical University Innsbruck

    STUDY CHAIR

Study Design

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

Study Record Dates

First Submitted

March 18, 2024

First Posted

March 25, 2024

Study Start

June 21, 2022

Primary Completion

August 18, 2022

Study Completion

August 18, 2022

Last Updated

March 25, 2024

Record last verified: 2024-03

Data Sharing

IPD Sharing
Will not share

Locations

AU(1)