Plaque Reduction Sesame Oil | NCT06327841

Studies
Plaque Reduction Sesame Oil

NCT06327841

Sponsor

Medical University Innsbruck

Status

Completed

Last Update Posted

Mar 25, 2024Actual

Enrollment

40Actual

Phase

Not Applicable

Conditions

Dental Plaque
Gingivitis
Oral Microbial Colonization

Interventions

sesame oil
distilled water

Countries

Austria

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2024

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 21, 2022Actual

Primary Completion Date

Aug 18, 2022Actual

Completion Date

Aug 18, 2022Actual

First Submitted Date

Mar 18, 2024

First Submission Date that Met QC Criteria

Mar 22, 2024

First Posted Date

Mar 25, 2024Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 22, 2024

Last Update Posted Date

Mar 25, 2024Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

40Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
sesame oil	Other	15min of oil pulling with 15ml sesame oil for 8 weeks	sesame oil

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

99 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Ines Kapferer-Seebacher	Medical University Innsbruck	Study Chair
Markus Nagl	Medical University Innsbruck	Study Chair

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Medical University		Innsbruck	Tyrol	6020	Austria

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
39786483	Derived	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.

ID	Term
D003741	Dental Deposits
D014076	Tooth Diseases
D009057	Stomatognathic Diseases
D007239	Infections

ID	Term
D004042	Dietary Fats, Unsaturated
D004041	Dietary Fats
D005223	Fats
D008055	Lipids

ID	Term
D003773	Dental Plaque
D005891	Gingivitis