Plaque Reduction Sesame Oil

Gingivitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06327841
• Other study ID #: EK 1117/2022
• Status: Completed
• Phase: N/A
• Start date: June 21, 2022
• Est. completion date: August 18, 2022

Study information

• Verified date: March 2024
• Source: Medical University Innsbruck
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: August 18, 2022
• Est. primary completion date: August 18, 2022
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 99 Years

Eligibility

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

Related Conditions & MeSH terms

• Communicable Diseases
• Dental Plaque
• Gingivitis
• Infections
• Oral Microbial Colonization

Intervention

Other:
• sesame oil
15min of oil pulling with 15ml sesame oil for 8 weeks
• distilled water
15min rinsing with 15ml distilled water for 8 weeks

Locations

Country	Name	City	State
Austria	Medical University	Innsbruck	Tyrol

Sponsors (1)

Lead Sponsor	Collaborator
Medical University Innsbruck

Country where clinical trial is conducted

Austria, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Rustogi Modified Navy Plaque Index (RMNPI)		first follow up after 4 weeks, full study duration 8 weeks
Secondary	Gingival Index (GI)		first follow up after 4 weeks, full study duration 8 weeks
Secondary	microbial analysis		first follow up after 4 weeks, full study duration 8 weeks
Secondary	Oral Health Impact Profile (OHIP)		first follow up after 4 weeks, full study duration 8 weeks
Secondary	Interview halitosis, xerostomia		first follow up after 4 weeks, full study duration 8 weeks