NCT06841380

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-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.

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 Apr 2023

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

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Study Timeline

Key milestones and dates

Study Start

First participant enrolled

April 25, 2023

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

June 22, 2023

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

June 22, 2023

Completed
1.7 years until next milestone

First Submitted

Initial submission to the registry

February 18, 2025

Completed
6 days until next milestone

First Posted

Study publicly available on registry

February 24, 2025

Completed
Last Updated

February 24, 2025

Status Verified

February 1, 2025

Enrollment Period

2 months

First QC Date

February 18, 2025

Last Update Submit

February 18, 2025

Conditions

Outcome Measures

Primary Outcomes (1)

  • Rustogi Modified Navy Plaque Index (RMNPI)

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

Secondary Outcomes (3)

  • 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

Study Arms (2)

sesame-based oil

EXPERIMENTAL

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

Other: sesame-based oil

distilled water

OTHER

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

Other: distilled water

Interventions

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

sesame-based oil

15min rinsing with 15ml distilled water for 8 weeks

distilled water

Eligibility Criteria

Age18 Years - 99 Years
Sexall
Healthy VolunteersYes
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

Innsbruck, Tyrol, 6020, Austria

Location

MeSH Terms

Conditions

Dental PlaqueGingivitis

Condition Hierarchy (Ancestors)

Dental DepositsTooth DiseasesStomatognathic DiseasesInfectionsGingival DiseasesPeriodontal DiseasesMouth Diseases

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

February 18, 2025

First Posted

February 24, 2025

Study Start

April 25, 2023

Primary Completion

June 22, 2023

Study Completion

June 22, 2023

Last Updated

February 24, 2025

Record last verified: 2025-02

Data Sharing

IPD Sharing
Will not share

Locations