GingivitisNCT04737798
Comparison of the Effects of Oil Pulling Therapy With Different Oils
A study testing oil pulling with coconut oil and oil pulling with sesame oil in people with Gingivitis, run by Baskent University at 1 site in Turkey (Türkiye).
Trial summary
Oil pulling" or "oil swishing" originates from ancient Ayurvedic medicine in India and now practiced in other parts of the world as a form of complementary and alternative medicine. It has been described as Kavalagraha or Gandhoosha in the ayurvedic texts of Charaka Samhita and Sushruta Samhita. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Gingivitis
- What is being tested?
- oil pulling with coconut oil and oil pulling with sesame oil
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 24 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 2 Jan 2020to 30 Apr 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- no systemic disease
- having ≥ 22 natural teeth,
- having no removable or fixed prostheses or fixed and removable orthodontic appliances.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Comparison of the Effects of Oil Pulling Therapy With Sesame Oil or Coconut Oil Using 4- Day Plaque Regrowth Study Model: A Randomized Crossover Clinical Trial
Oil pulling" or "oil swishing" originates from ancient Ayurvedic medicine in India and now practiced in other parts of the world as a form of complementary and alternative medicine. It has been described as Kavalagraha or Gandhoosha in the ayurvedic texts of Charaka Samhita and Sushruta Samhita. It is a procedure that involves swishing oil in the mouth a period of 15 min, before spitting it out.
In addition to its systemic benefits, oil pulling therapy has also benefits on oral health.
Read more
The oil pulling therapy can be performed by using edible oils like sesame oil, sunflower oil and coconut oil. However, there is only one study in the literature comparing the effect of oil pulling therapy using coconut oil versus sesame oil on plaque-induced gingivitis and the results were in favor of coconut oil.
In order to clarify the gap in the literature on this field, this study was designed to compare the plaque-inhibiting effects of oil pulling therapy with sesame oil or coconut oil using 4- day plaque regrowth study model.
Read the detailed description
The study is conducted as an observer masked, cross over design with a single-center where the participants were randomly allocated to groups. Before the initiation of the study period all participants underwent thorough scaling and polishing of the teeth by both hand and ultrasonic instruments to remove all plaque, calculus and stain and were instructed in how to maintain oral hygiene. This phase considered as a preparatory period by the end of this period all participants obtained healthy gingiva clinically.
The randomization of the participants were provided by closed envelop system (BM). The conductors of the study were blinded to the mouthrinses received by participants. The tested products and regimens of use are shown in Table 1. Identical coded bottles were used to fill the mouthrinses. The bottles also had stickers on explaining the usage instructions. On the first day of each study period, to confirm all patients to have plaque score of 0 at the baseline, erythrosine was applied to all teeth and then scaling and polishing to remove plaque and extrinsic stain and disclosing of the teeth was performed. All tooth cleaning applications (other rinse, chewing gum or toothbrushing / toothpaste) were forbidden for 4 days of study protocol and rinsing regimen was performed. The tested agents included the following: 1) Sesame oil (10 ml, twice daily 15-20 minute) 2) Coconut oil (10 ml, twice daily 15-20 minute). Participants were instructed to perform the mouthrinsing after breakfast and dinner and to avoid rinsing, eating and drinking following hour after rinsing. Even though the mouthrinses were in provided identical bottles and patients were not informed about the products however due to the taste and color differences of the products total subject blindness could not be achieved.
On day 5 (Friday), each subject was scored for staining using Lobene stain index following an oral soft tissue examination. Following the satin scoring erythrosine disclosing was performed and Turesky et al. modification of the Quigley and Hein index was used for plaque scoring. All buccal and lingual surfaces of all fully erupted permanent teeth, with the exception of the third molars were scored for stain and plaque. Six sites of each teeth were also used to score Gingival Index (GI) and bleeding on probing (BOP). All clinical examinations were performed by a single trained and calibrated clinician (YS) who was masked to the study.
Following the recording of clinical parameters, all plaque and tooth stain (if present) were removed by polishing and washout period of 14 days was awaited after the second phase of the study. For the washout period, the subjects were instructed to go on to their routine oral hygiene habits. Following this period the procedures explained before were repeated until each participant used each of the rinses for the second phase of the study.
Standardized questionnaire were filled by the participants in order to evaluate their attitudes and occurrence of adverse effects with regard to the product used at the end of each phase. The questions evaluated 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. Five point Likert type scale was used to collect the responses to the questions which ranged from 1- "very negative" to 5- "very positive" excluding the question about the preference of the product. At the end of each phase participants were asked to bring the bottles to control the remaining mouthrinses in order to control the compliance of the participants.
- Conditions
- Gingivitis
- Being tested
- oil pulling with coconut oil, oil pulling with sesame oil
- Keywords
- oil pulling, gingivitis
- Medical subject headings
- Gingivitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oil pulling with coconut oilOther
using oil pulling therapy with coconut oil
oil pulling with sesame oilOther
using oil pulling therapy with sesame oil
| Study group | Role | What they receive |
|---|---|---|
| oil pulling with coconut oil | Experimental | patients used oil pulling therapy with coconut oil for 4 days Receives: Other: oil pulling with coconut oil |
| oil pulling with sesame oil | Active comparator | patients used oil pulling therapy with sesame oil for 4 days Receives: Other: oil pulling with sesame oil |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: day 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Feb 2021
- Study start2 Jan 2020
- Primary completion22 Apr 2020
- Study completion30 Apr 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GingivitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 24 participants (actual)
Sponsor and investigators
- Lead sponsor
- Baskent University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yasemin Sezgin, Baskent University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04737798
- Sponsor's protocol ID
- BaskentU7
- Status last verified
- Jan 2021
- First submitted
- 30 Jan 2021
- Last updated
- 4 Feb 2021
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 4 Feb 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Comparison of the Effects of Oil Pulling Therapy With Sesame Oil or Coconut Oil Using 4- Day Plaque Regrowth Study Model: A Randomized Crossover Clinical Trial
- ClinicalTrials.gov ID
- NCT04737798
- Acronym / sponsor ID
- BaskentU7
- Conditions
- Gingivitis
- Keywords
- oil pulling, gingivitis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 24 participants (actual)
- Lead sponsor
- Baskent UniversityUniversity, hospital or other
- Study start
- 2 Jan 2020 (actual)
- Primary completion
- 22 Apr 2020 (actual)
- Study completion
- 30 Apr 2020 (actual)
- First posted
- 4 Feb 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Oil pulling" or "oil swishing" originates from ancient Ayurvedic medicine in India and now practiced in other parts of the world as a form of complementary and alternative medicine. It has been described as Kavalagraha or Gandhoosha in the ayurvedic texts of Charaka Samhita and Sushruta Samhita. It is a procedure that involves swishing oil in the mouth a period of 15 min, before spitting it out.
In addition to its systemic benefits, oil pulling therapy has also benefits on oral health.
The oil pulling therapy can be performed by using edible oils like sesame oil, sunflower oil and coconut oil. However, there is only one study in the literature comparing the effect of oil pulling therapy using coconut oil versus sesame oil on plaque-induced gingivitis and the results were in favor of coconut oil.
In order to clarify the gap in the literature on this field, this study was designed to compare the plaque-inhibiting effects of oil pulling therapy with sesame oil or coconut oil using 4- day plaque regrowth study model.
Detailed description
The study is conducted as an observer masked, cross over design with a single-center where the participants were randomly allocated to groups. Before the initiation of the study period all participants underwent thorough scaling and polishing of the teeth by both hand and ultrasonic instruments to remove all plaque, calculus and stain and were instructed in how to maintain oral hygiene. This phase considered as a preparatory period by the end of this period all participants obtained healthy gingiva clinically.
The randomization of the participants were provided by closed envelop system (BM). The conductors of the study were blinded to the mouthrinses received by participants. The tested products and regimens of use are shown in Table 1. Identical coded bottles were used to fill the mouthrinses. The bottles also had stickers on explaining the usage instructions. On the first day of each study period, to confirm all patients to have plaque score of 0 at the baseline, erythrosine was applied to all teeth and then scaling and polishing to remove plaque and extrinsic stain and disclosing of the teeth was performed. All tooth cleaning applications (other rinse, chewing gum or toothbrushing / toothpaste) were forbidden for 4 days of study protocol and rinsing regimen was performed. The tested agents included the following: 1) Sesame oil (10 ml, twice daily 15-20 minute) 2) Coconut oil (10 ml, twice daily 15-20 minute). Participants were instructed to perform the mouthrinsing after breakfast and dinner and to avoid rinsing, eating and drinking following hour after rinsing. Even though the mouthrinses were in provided identical bottles and patients were not informed about the products however due to the taste and color differences of the products total subject blindness could not be achieved.
On day 5 (Friday), each subject was scored for staining using Lobene stain index following an oral soft tissue examination. Following the satin scoring erythrosine disclosing was performed and Turesky et al. modification of the Quigley and Hein index was used for plaque scoring. All buccal and lingual surfaces of all fully erupted permanent teeth, with the exception of the third molars were scored for stain and plaque. Six sites of each teeth were also used to score Gingival Index (GI) and bleeding on probing (BOP). All clinical examinations were performed by a single trained and calibrated clinician (YS) who was masked to the study.
Following the recording of clinical parameters, all plaque and tooth stain (if present) were removed by polishing and washout period of 14 days was awaited after the second phase of the study. For the washout period, the subjects were instructed to go on to their routine oral hygiene habits. Following this period the procedures explained before were repeated until each participant used each of the rinses for the second phase of the study.
Standardized questionnaire were filled by the participants in order to evaluate their attitudes and occurrence of adverse effects with regard to the product used at the end of each phase. The questions evaluated 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. Five point Likert type scale was used to collect the responses to the questions which ranged from 1- "very negative" to 5- "very positive" excluding the question about the preference of the product. At the end of each phase participants were asked to bring the bottles to control the remaining mouthrinses in order to control the compliance of the participants.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| oil pulling with coconut oil | Experimental | Other: oil pulling with coconut oilpatients used oil pulling therapy with coconut oil for 4 days |
| oil pulling with sesame oil | Active comparator | Other: oil pulling with sesame oilpatients used oil pulling therapy with sesame oil for 4 days |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- no systemic disease
- having ≥ 22 natural teeth,
- having no removable or fixed prostheses or fixed and removable orthodontic appliances.
Key exclusion criteria (6 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oil pulling with coconut oilusing oil pulling therapy with coconut oil | Other | oil pulling with coconut oil |
| oil pulling with sesame oilusing oil pulling therapy with sesame oil | Other | oil pulling with sesame oil |
Primary outcome
plaque index
Time frame: day 5
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
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 4 Feb 2021.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing oil pulling with coconut oil and oil pulling with sesame oil in people with Gingivitis, run by Baskent University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 4 Feb 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
plaque index (time frame: day 5). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 4 Feb 2021.