NCT03962777

Brief Summary

Oil pulling is a method based on Ayurvedic medicine which aims to obtain local and systemic benefits by swirling oils in the oral cavity for a period of 15 minutes, before spitting it out.12 Although the exact mechanism of action is not clear, there are some proposed theories. One proposed theory is the saponification or "soap making" process which occurs as a result of alkali hydrolysis of fat.9 Second theory speculates the inhibition of plaque formation and adhesion of bacteria due to the viscous nature of the oil. 13 According to the third theory, presence of antioxidants in oil prevent lipid peroxidation and thus help to the destruction of microorganisms and potentiating the action of Vitamin E in the oral cavity.14 The effect of oil pulling on halitosis and the use of oil pulling in addition to conventional oral hygiene practices was investigated in some studies13,15,16 but to the best knowledge of the authors, no study has evaluated the plaque-inhibiting effects of oil pulling. Therefore this study was conducted to evaluate the plaque-inhibiting effects of oil pulling using 4- day plaque regrowth study model17,18 compared to 0.2% CHX-containing mouthrinse. The tested hypothesis was that oil pulling would perform plaque regrowth inhibition as well as the CHX-containing mouthrinse.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Feb 2019

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

February 9, 2019

Completed
3 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 9, 2019

Completed
6 days until next milestone

Study Completion

Last participant's last visit for all outcomes

May 15, 2019

Completed
7 days until next milestone

First Submitted

Initial submission to the registry

May 22, 2019

Completed
2 days until next milestone

First Posted

Study publicly available on registry

May 24, 2019

Completed
Last Updated

May 29, 2019

Status Verified

May 1, 2019

Enrollment Period

3 months

First QC Date

May 22, 2019

Last Update Submit

May 25, 2019

Conditions

Keywords

gingivitisoil pulling

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 4

Study Arms (2)

oil pulling

EXPERIMENTAL

patients used oil pulling therapy for 4 days

Other: oil pulling

chlorhexidine

ACTIVE COMPARATOR

patients used chlorhexidine digluconate for 4 days

Other: chlorhexidine

Interventions

patients used chx moutrinses for four days

chlorhexidine

patients used oil pulling for four days

oil pulling

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, Please Select..., 06690, Turkey (Türkiye)

Location

MeSH Terms

Conditions

Gingivitis

Interventions

Chlorhexidine

Condition Hierarchy (Ancestors)

InfectionsGingival DiseasesPeriodontal DiseasesMouth DiseasesStomatognathic Diseases

Intervention Hierarchy (Ancestors)

BiguanidesGuanidinesAmidinesOrganic Chemicals

Study Officials

  • yasemin sezgin, asst prof

    başkent university, faculty of dentistry

    STUDY DIRECTOR

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
asistant professor

Study Record Dates

First Submitted

May 22, 2019

First Posted

May 24, 2019

Study Start

February 9, 2019

Primary Completion

May 9, 2019

Study Completion

May 15, 2019

Last Updated

May 29, 2019

Record last verified: 2019-05

Data Sharing

IPD Sharing
Will not share

Locations