NCT04737798

Brief Summary

Oil pulling" or "oil swishing" originates from ancient Ayurvedic medicine in India and now practiced in other parts of the world as a form of complementary and alternative medicine. It has been described as Kavalagraha or Gandhoosha in the ayurvedic texts of Charaka Samhita and Sushruta Samhita. It is a procedure that involves swishing oil in the mouth a period of 15 min, before spitting it out. In addition to its systemic benefits, oil pulling therapy has also benefits on oral health. The oil pulling therapy can be performed by using edible oils like sesame oil, sunflower oil and coconut oil. However, there is only one study in the literature comparing the effect of oil pulling therapy using coconut oil versus sesame oil on plaque-induced gingivitis and the results were in favor of coconut oil. In order to clarify the gap in the literature on this field, this study was designed to compare the plaque-inhibiting effects of oil pulling therapy with sesame oil or coconut oil using 4- day plaque regrowth study model.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
24

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jan 2020

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

January 2, 2020

Completed
4 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 22, 2020

Completed
8 days until next milestone

Study Completion

Last participant's last visit for all outcomes

April 30, 2020

Completed
9 months until next milestone

First Submitted

Initial submission to the registry

January 30, 2021

Completed
5 days until next milestone

First Posted

Study publicly available on registry

February 4, 2021

Completed
Last Updated

February 4, 2021

Status Verified

January 1, 2021

Enrollment Period

4 months

First QC Date

January 30, 2021

Last Update Submit

January 30, 2021

Conditions

Keywords

oil pullinggingivitis

Outcome Measures

Primary Outcomes (1)

  • plaque index

    plaque regrowth inhibition will be tested using the Turesky et al. 21 modification of the Quigley and Hein index.a score of 0 to 5 is assigned to each facial and lingual nonrestored surface of all the teeth except third molars, as follows: 0: No plaque; 1:Separate flecks of plaque at the cervical margin of the tooth; 2:A thin continuos band of plaque (up to one mm) at the cervical margin of the tooth; 3: A band of plaque wider than one mm but covering less than one-third of the crown of the tooth; 4:Plaque covering at least one-third but less than two-thirds of the crown of the tooth; 5: Plaque covering two-thirds or more of the crown of the tooth. An index for the entire mouth is determined by dividing the total score by the number surfaces ( a maximum of 2 x 2 x 14 = 56 surfaces) examined.lower values means that the agent has better plaque inhbiting effect

    day 5

Study Arms (2)

oil pulling with coconut oil

EXPERIMENTAL

patients used oil pulling therapy with coconut oil for 4 days

Other: oil pulling with coconut oil

oil pulling with sesame oil

ACTIVE COMPARATOR

patients used oil pulling therapy with sesame oil for 4 days

Other: oil pulling with sesame oil

Interventions

using oil pulling therapy with coconut oil

oil pulling with coconut oil

using oil pulling therapy with sesame oil

oil pulling with sesame oil

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • no systemic disease
  • having ≥ 22 natural teeth,
  • having no removable or fixed prostheses or fixed and removable orthodontic appliances.

You may not qualify if:

  • use of antibiotics and anti-inflammatory drugs in previous 6 months
  • allergy to any ingredient used in the study
  • smokers
  • pregnant of lactating females
  • history of mouthrinses, gels or chewing gums use that contains antimicrobial agents in the preceding 3 months
  • having teeth with probing depth ≥4mm and signs of gingival inflammation.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Yasemin Sezgin

Ankara, 06690, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Coconut OilSesame Oil

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

Dietary FatsFatsLipidsPlant OilsOilsDietary Fats, UnsaturatedFats, UnsaturatedPlant PreparationsBiological ProductsComplex MixturesFoodDiet, Food, and NutritionPhysiological PhenomenaFood and Beverages

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
PREVENTION
Intervention Model
CROSSOVER
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
associate prof

Study Record Dates

First Submitted

January 30, 2021

First Posted

February 4, 2021

Study Start

January 2, 2020

Primary Completion

April 22, 2020

Study Completion

April 30, 2020

Last Updated

February 4, 2021

Record last verified: 2021-01

Data Sharing

IPD Sharing
Will not share

Locations