Efficacy of Oil Pulling Therapy on Supragingival Plaque Growth
1 other identifier
interventional
30
1 country
1
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
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Feb 2019
Shorter than P25 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
February 9, 2019
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 9, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
May 15, 2019
CompletedFirst Submitted
Initial submission to the registry
May 22, 2019
CompletedFirst Posted
Study publicly available on registry
May 24, 2019
CompletedMay 29, 2019
May 1, 2019
3 months
May 22, 2019
May 25, 2019
Conditions
Keywords
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
EXPERIMENTALpatients used oil pulling therapy for 4 days
chlorhexidine
ACTIVE COMPARATORpatients used chlorhexidine digluconate for 4 days
Interventions
Eligibility Criteria
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)
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
yasemin sezgin, asst prof
başkent university, faculty of dentistry
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