- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03962777
Efficacy of Oil Pulling Therapy on Supragingival Plaque Growth
Efficacy of Oil Pulling Therapy With Coconut Oil on Four Day Supragingival Plaque Growth: a Randomized Crossover Clinical Trial
Study Overview
Status
Conditions
Intervention / Treatment
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.
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Please Select...
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Ankara, Please Select..., Turkey, 06690
- Yasemin Sezgin
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: CROSSOVER
- Masking: DOUBLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
EXPERIMENTAL: oil pulling
patients used oil pulling therapy for 4 days
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patients used oil pulling for four days
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ACTIVE_COMPARATOR: chlorhexidine
patients used chlorhexidine digluconate for 4 days
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patients used chx moutrinses for four days
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
plaque index
Time Frame: day 4
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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
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day 4
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Collaborators and Investigators
Sponsor
Investigators
- Study Director: yasemin sezgin, asst prof, başkent university, faculty of dentistry
Study record dates
Study Major Dates
Study Start (ACTUAL)
Primary Completion (ACTUAL)
Study Completion (ACTUAL)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (ACTUAL)
Study Record Updates
Last Update Posted (ACTUAL)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- BaskentU5
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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