- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT05304338
Evaluation of the Effect of Oil Pulling
Evaluation of the Effect of Oil Pulling on Dental and Gingival Health
The objectives of this study were to evaluate the inhibitory effect on plaque and the tooth discoloration associated with agents used in the chemical plaque control of oil pulling in comparison with chlorhexidine-containing mouthwash and water in a four-day plaque regrowth model.
One hundred dentistry students were included in this randomized, parallel-group, placebo-controlled clinical study. In this study, participants were divided into 5 equal groups: Group 1: Gargling with 0.2% chlorhexidine; Group 2: Oil pulling with coconut oil; Group 3: Oil pulling with black cumin oil; Group 4: Oil pulling with terebinth oil; Group 4: Gargling with distilled water. Participants were instructed to refrain from mechanical oral hygiene and rinse only with the allocated mouth rinse during the four-day period. The differences in plaque index, gingival index, and tooth discoloration were evaluated in the study.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
None Selected
-
Erzurum, None Selected, Turkey, 25240
- Ataturk University
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Without systemic disease,
- Had at least 24 teeth, and
- Without fixed or removable prostheses or orthodontic appliances
Exclusion Criteria:
- Individuals with a history of systemic or topical oral antimicrobial therapy use in the last 3 months
- Individuals with an allergy to any ingredient used in the study
- Smokers
- Pregnant or breastfeeding women
- Individuals with ≥2 mm gingival recession
Study Plan
How is the study designed?
Design Details
- Primary Purpose: PREVENTION
- Allocation: RANDOMIZED
- Interventional Model: PARALLEL
- Masking: TRIPLE
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
ACTIVE_COMPARATOR: Chlorhexidine
|
Gargling with 10 mL 0.2% Chlorhexidine
|
|
EXPERIMENTAL: Coconut Oil
|
In oil pulling therapy, a tablespoon of edible oil is placed in the mouth and swirled between the teeth for 15 to 20 minutes
|
|
EXPERIMENTAL: Black Cumin Oil
|
In oil pulling therapy, a tablespoon of edible oil is placed in the mouth and swirled between the teeth for 15 to 20 minutes
|
|
EXPERIMENTAL: Terebinth Oil
|
In oil pulling therapy, a tablespoon of edible oil is placed in the mouth and swirled between the teeth for 15 to 20 minutes
|
|
PLACEBO_COMPARATOR: Distilled Water
|
Gargling with 10 mL distilled water
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Dental Plaque
Time Frame: Day 4
|
Plaque scores recorded by using the Quigley-Hein and Turesky plaque index (Q-H).
|
Day 4
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Tooth Color
Time Frame: Day 1- Day 4
|
The tooth color was determined with a digital spectrophotometer
|
Day 1- Day 4
|
Collaborators and Investigators
Sponsor
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
Additional Relevant MeSH Terms
Other Study ID Numbers
- 8948 (Tabriz University of Medical Sciences)
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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