Oral HygieneNCT05304338
Evaluation of the Effect of Oil Pulling
A study testing Chlorhexidine, Oil Pulling and Distilled Water in people with Oral Hygiene and Dental Plaque, run by Ataturk University at 1 site in Turkey (Türkiye).
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 25 yearsHealthy volunteers can take part
- Conditions the study is for
- Oral Hygiene, Dental Plaque
- What is being tested?
- Chlorhexidine, Oil Pulling and Distilled Water
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 100 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 10 Oct 2021to 21 Jan 2022
- 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 25 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- Without systemic disease,
- Had at least 24 teeth, and
- Without fixed or removable prostheses or orthodontic appliances
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Ataturk University
Erzurum, None Selected, 25240
About this study
Official title: 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.
- Conditions
- Oral Hygiene, Dental Plaque
- Being tested
- Chlorhexidine, Oil Pulling, Distilled Water
- Keywords
- Chlorhexidine, Oil pulling, Plaque Regrowth model, Coconut oil, Digital spectrophotometer
- Medical subject headings
- Dental Plaque
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
ChlorhexidineDrug
Gargling with 10 mL 0.2% Chlorhexidine
Oil PullingOther
In oil pulling therapy, a tablespoon of edible oil is placed in the mouth and swirled between the teeth for 15 to 20 minutes
Distilled WaterOther
Gargling with 10 mL distilled water
| Study group | Role | What they receive |
|---|---|---|
| Chlorhexidine | Active comparator | Not described Receives: Drug: Chlorhexidine |
| Coconut Oil | Experimental | Not described Receives: Other: Oil Pulling |
| Black Cumin Oil | Experimental | Not described Receives: Other: Oil Pulling |
| Terebinth Oil | Experimental | Not described Receives: Other: Oil Pulling |
| Distilled Water | Placebo comparator | Not described Receives: Other: Distilled Water |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dental Plaque
Plaque scores recorded by using the Quigley-Hein and Turesky plaque index (Q-H).
Measured: Day 4
Secondary outcomes (1)
Tooth Color
The tooth color was determined with a digital spectrophotometer
Measured: Day 1- Day 4
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted31 Mar 2022
- Study start10 Oct 2021
- Primary completion25 Nov 2021
- Study completion21 Jan 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HygieneStudies of the same condition, open and under way.
- More trials run by Ataturk UniversityThe sponsor's other registered studies.
- 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
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Ataturk University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ahmet Bedreddin Şahin, Ataturk University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05304338
- Sponsor's protocol ID
- 8948
- Status last verified
- Mar 2022
- First submitted
- 22 Mar 2022
- Last updated
- 31 Mar 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effect of Oil Pulling on Dental and Gingival Health
- ClinicalTrials.gov ID
- NCT05304338
- Acronym / sponsor ID
- 8948
- Conditions
- Oral Hygiene, Dental Plaque
- Keywords
- Chlorhexidine, Oil pulling, Plaque Regrowth model, Coconut oil, Digital spectrophotometer
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Ataturk UniversityUniversity, hospital or other
- Study start
- 10 Oct 2021 (actual)
- Primary completion
- 25 Nov 2021 (actual)
- Study completion
- 21 Jan 2022 (actual)
- First posted
- 31 Mar 2022 (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.
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 design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 5
| Arm | Type | Receives |
|---|---|---|
| Chlorhexidine | Active comparator | Drug: Chlorhexidine |
| Coconut Oil | Experimental | Other: Oil Pulling |
| Black Cumin Oil | Experimental | Other: Oil Pulling |
| Terebinth Oil | Experimental | Other: Oil Pulling |
| Distilled Water | Placebo comparator | Other: Distilled Water |
Who may qualify
- Ages
- 18 to 25 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Without systemic disease,
- Had at least 24 teeth, and
- Without fixed or removable prostheses or orthodontic appliances
Key exclusion criteria (5 listed)
- 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
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 |
|---|---|---|
| ChlorhexidineGargling with 10 mL 0.2% Chlorhexidine | Drug | Chlorhexidine |
| Oil PullingIn oil pulling therapy, a tablespoon of edible oil is placed in the mouth and swirled between the teeth for 15 to 20 minutes | Other | Black Cumin Oil, Coconut Oil, Terebinth Oil |
| Distilled WaterGargling with 10 mL distilled water | Other | Distilled Water |
Primary outcome
Dental Plaque
Time frame: Day 4
Plaque scores recorded by using the Quigley-Hein and Turesky plaque index (Q-H).
1 secondary outcome
Tooth Color
Time frame: Day 1- Day 4
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 31 Mar 2022.
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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 Chlorhexidine, Oil Pulling and Distilled Water in people with Oral Hygiene and Dental Plaque, run by Ataturk 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 5 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 31 Mar 2022. 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. Some participants in this study may receive a placebo. 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?
Dental Plaque (time frame: Day 4). 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 31 Mar 2022.