Efficacy of Oil Pulling Therapy on Supragingival Plaque Growth
Primary Purpose
Gingivitis
Status
Completed
Phase
Not Applicable
Locations
Turkey
Study Type
Interventional
Intervention
chlorhexidine
oil pulling
Sponsored by
About this trial
This is an interventional prevention trial for Gingivitis focused on measuring gingivitis, oil pulling
Eligibility Criteria
Inclusion Criteria:
- no systemic disease
- having ≥ 22 natural teeth,
- having no removable or fixed prostheses or fixed and removable orthodontic appliances.
Exclusion criteria:
- 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.
Sites / Locations
- Yasemin Sezgin
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
oil pulling
chlorhexidine
Arm Description
patients used oil pulling therapy for 4 days
patients used chlorhexidine digluconate for 4 days
Outcomes
Primary Outcome Measures
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
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03962777
Brief Title
Efficacy of Oil Pulling Therapy on Supragingival Plaque Growth
Official Title
Efficacy of Oil Pulling Therapy With Coconut Oil on Four Day Supragingival Plaque Growth: a Randomized Crossover Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
February 9, 2019 (Actual)
Primary Completion Date
May 9, 2019 (Actual)
Study Completion Date
May 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Baskent University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
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.
Detailed Description
The study was a single-center, observer masked, cross-over design with subjects randomly allocated to treatment sequences. During a 2-week preparatory period, participants rendered plaque, calculus and stain free by a thorough scaling and polishing of the teeth by both hand and ultrasonic instruments and were instructed in self-performed plaque control. At the end of the preparatory period, all subjects had clinically healthy gingiva.
Participants were randomly allocated to two groups by closed envelop system (BM) and masked to the mouthrinse received. The tested products and regimens of use are shown in Table 1. Mouthrinses were filled in identical but coded bottles. Instructions for usage was written on the bottles. On day 1 (Monday) of each study periods, after disclosing the teeth with erythrosine all subjects received scaling and polishing to remove plaque and extrinsic stain and disclosing of the teeth was repeated. By this way it was confirmed that all participants had a plaque score of 0 at baseline. Subjects were then asked to refrain from all forms of tooth cleaning and to apply the rinsing regimen. The tested agents included the following: 1) 0.2 % chlorhexidine mouthrinse ( 10 mL, twice daily for 30 seconds) 2) Coconut oil (10 Ml, twice daily 15-20 minute) All agents were to be used after breakfast and dinner and the subjects should be avoided rinsing, eating and drinking during the first hour after rinsing. During the 4- day period, the use of any other rinse, chewing gum or toothpaste was not allowed. The mouthrinses were in identical bottles but total subject blindness cannot be possible due to the taste, color, consistency, rinsing time differences.
On day 5 (Friday), subjects received an oral soft tissue examination and were asked to complete a standardized questionnaire to evaluate their attitudes with regard to the product used. The patients were asked about the flavor of the mouthrinse, the alteration in the taste of food and drinks, the perception of the plaque reduction, the staining that the mouthrinse created, the feeling to create nausea. After the completion of the questionnaire, each subject was scored for staining using Lobene stain index.19 After that, disclosing was performed with erythrosine and plaque scoring was performed using the Turesky et al. 20 modification of the Quigley and Hein index.21 Stain and plaque indices were recorded from the buccal and lingual surfaces of all fully erupted permanent teeth, with the exception of the third molars. In addition, Gingival Index (GI) and bleeding on probing (bop) were recorded from six sites of each teeth. All clinical examinations were performed by a single clinician (YS) who was masked to the study.
After recording the clinical parameters, subjects received a polishing to remove all plaque and tooth stain if present and 14 days of washout periods were allowed after 4- day period. 22 During the wash out period, the subjects returned to normal oral hygiene methods with a standard toothbrush* and a fluoride containing tooth paste**. These procedures were repeated until each participant used each of the rinses.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gingivitis
Keywords
gingivitis, oil pulling
7. Study Design
Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
30 (Actual)
8. Arms, Groups, and Interventions
Arm Title
oil pulling
Arm Type
Experimental
Arm Description
patients used oil pulling therapy for 4 days
Arm Title
chlorhexidine
Arm Type
Active Comparator
Arm Description
patients used chlorhexidine digluconate for 4 days
Intervention Type
Other
Intervention Name(s)
chlorhexidine
Intervention Description
patients used chx moutrinses for four days
Intervention Type
Other
Intervention Name(s)
oil pulling
Intervention Description
patients used oil pulling for four days
Primary Outcome Measure Information:
Title
plaque index
Description
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
Time Frame
day 4
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
no systemic disease
having ≥ 22 natural teeth,
having no removable or fixed prostheses or fixed and removable orthodontic appliances.
Exclusion criteria:
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
yasemin sezgin, asst prof
Organizational Affiliation
başkent university, faculty of dentistry
Official's Role
Study Director
Facility Information:
Facility Name
Yasemin Sezgin
City
Ankara
State/Province
Please Select...
ZIP/Postal Code
06690
Country
Turkey
12. IPD Sharing Statement
Plan to Share IPD
No
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Efficacy of Oil Pulling Therapy on Supragingival Plaque Growth
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