Plaque Reduction Sesame Oil

March 22, 2024 updated by: Christine Zürcher, Medical University Innsbruck

The Plaque Reducing Efficacy of Oil Pulling With Sesame Oil. A Randomized-controlled Clinical Study

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

40

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

  • Austria
    • Tyrol
      • Innsbruck, Tyrol, Austria, 6020
        • Medical University

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

No

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: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: sesame oil
8 weeks oil pulling with sesame oil 15ml 15min every morning
Other: sesame oil
15min of oil pulling with 15ml sesame oil for 8 weeks
Other: distilled water
8 weeks rinsing with distilled water 15ml 15min every morning
Other: distilled water
15min rinsing with 15ml distilled water for 8 weeks

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Rustogi Modified Navy Plaque Index (RMNPI)
Time Frame: first follow up after 4 weeks, full study duration 8 weeks
first follow up after 4 weeks, full study duration 8 weeks

Secondary Outcome Measures

Outcome Measure
Time Frame
Gingival Index (GI)
Time Frame: first follow up after 4 weeks, full study duration 8 weeks
first follow up after 4 weeks, full study duration 8 weeks
microbial analysis
Time Frame: first follow up after 4 weeks, full study duration 8 weeks
first follow up after 4 weeks, full study duration 8 weeks
Oral Health Impact Profile (OHIP)
Time Frame: first follow up after 4 weeks, full study duration 8 weeks
first follow up after 4 weeks, full study duration 8 weeks
Interview halitosis, xerostomia
Time Frame: first follow up after 4 weeks, full study duration 8 weeks
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

Medical University Innsbruck

Investigators

  • Study Chair: Ines Kapferer-Seebacher, Medical University Innsbruck
  • Study Chair: Markus Nagl, Medical University Innsbruck

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)

June 21, 2022

Primary Completion (Actual)

August 18, 2022

Study Completion (Actual)

August 18, 2022

Study Registration Dates

First Submitted

March 18, 2024

First Submitted That Met QC Criteria

March 22, 2024

First Posted (Actual)

March 25, 2024

Study Record Updates

Last Update Posted (Actual)

March 25, 2024

Last Update Submitted That Met QC Criteria

March 22, 2024

Last Verified

March 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EK 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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