Oral HealthNCT06363721
A Pilot Study of a Commercially-available Oil Rinse Product (PerioPull™) on Markers of Dental Health
A study testing PerioPull™ in people with Oral Health, run by Designs for Health at 1 site in United States.
Trial summary
The primary purpose of this study is to evaluate the impact of a commercially-available oil rinse product (PerioPull™) on parameters of dental health among a sample of adults. PerioPull™ is commercially available and sold primarily from clinicians' offices. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Health
- What is being tested?
- PerioPull™
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 18 participants
- Where
- 1 siteUnited States
- Study dates
- 10 Jul 2024to Aug 2025
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Plaque index of at least 1
- Gingival index of at least 1
- Pocket depth no greater than 5 mm
- Able to understand and write English
- Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects
- Maintain current dental hygiene routine
- Bleeding on probing
Who cannot join
- Current daily use of any products containing the nutrients and/or herbs in the study product
- Known allergies to any substance in the study product
- Current daily tobacco smoker
- Currently pregnant or lactating women or women planning to become pregnant in the next 12 weeks
- Active oral infection (ie. herpes, candida)
- Recently on antibiotics (past 3 months)
- Undergone recent periodontal therapy (last 6 months)
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
United States1 site, 1 recruiting
- Recruiting
Julian Center for Comprehensive Dentistry
Ellicott City, Maryland, 21042
Eugene Sambataro, DDS, 410-834-0796, drsam@julianctr.com
Eugene Sambataro, DDS
About this study
The primary purpose of this study is to evaluate the impact of a commercially-available oil rinse product (PerioPull™) on parameters of dental health among a sample of adults. PerioPull™ is commercially available and sold primarily from clinicians' offices.
A 12-week pilot study will be conducted to achieve the purpose of this study. The research team hypothesizes that PerioPull™ will improve a variety of validated markers of dental health that are commonly used in clinical practice.
Read the detailed description
Patients that suffer from dental health issues often have a deeper than normal pocket depth. These pockets can become filled with infection causing bacteria causing inflammation around the tooth leading to periodontal disease.
The current recommendations are to brush with Sensodyne, use a special mouthwash, do not brush as hard, or use an electric toothbrush.
PerioPull™ is a natural oil rinse formula to support overall oral/gum health, tooth stains, and natural teeth whitening. This formula contains specific nutrients that have been previously studied and shown to be efficacious in oral health These actions do not have any known side effects, which present an advantage over standard dental treatments with fluoride, chlorhexidine, hydrogen peroxide and other chemicals.
This oil rinse formula is a commercially available product sold primarily from physicians' offices. As indicated in the ingredient list provided below, PerioPull™ includes Medium Chain Triglycerides (C8, C10, C12) (from coconut oil), Bixa orellana (Annatto) Seed Extract (GG-Gold®), Natural Mint Flavor, Bromelain, Ubiquionone, Delta Tocotrienols.
The proposed study is a 12-week pilot study of PerioPull™. Eligible participants will be recruited from within the clinical practice of the periodontist.
Study outcomes will consist of parameters of dental health among a sample of adults. These outcomes will be collected during a dental visit and assessed at baseline, six weeks, and at the conclusion of the 12-week clinical trial.
Oral samples that are obtained during clinical visits will be sent to lab utilized by participating clinical practices for analysis of study outcomes.
The outcomes in this clinical trial have been studied in previous clinical trials among dental patients. One oral sample at each of the three study visits is all that is required to collect outcomes.
All study outcomes will be measurements and testing during three dental visits spaced 6 weeks apart. These are typical assessments in routine clinical practice.
- Conditions
- Oral Health
- Being tested
- PerioPull™
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PerioPull™Dietary supplement
PerioPull™ is a natural oil rinse formula to support overall oral/gum health, tooth stains, and natural teeth whitening. PerioPull™ includes Medium Chain Triglycerides (C8, C10, C12) (from coconut oil), Bixa orellana (Annatto) Seed Extract (GG-Gold®), Natural Mint Flavor, Bromelain, Ubiquinone, Delta Tocotrienols.
| Study group | Role | What they receive |
|---|---|---|
| PerioPull™ | Experimental | Participants will swish 1 teaspoon (approx. 5 mL) of oil in the mouth for a minimum of 5 minutes after their normal brushing routine, as is suggested on the label of the bottle. They will spit out the oil and not rinse to allow for longer contact to the teeth and gums. This will be once a day for 12 weeks. Receives: Dietary Supplement: PerioPull™ |
What is being measured
The primary outcome is the main question the study is designed to answer.
Plaque Index
Assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth, except the third molars. The bacterial plaque developer solution was used to define cumulative amounts of plaque with criteria from 0 to 5. Once the values of the individual teeth are recorded, they are added and divided by the number of teeth examined to obtain the plaque index of each patient.
Measured: Baseline, 6 weeks, and 12 weeks
Gingival Index
A method of recording the clinical severity of gingival inflammation. It is based upon probe measurement of periodontal pockets and on gingival tissue status.
Measured: Baseline, 6 weeks, and 12 weeks
Pocket Depth
A measurement in millimeters of the depth from the gingival margin to the epithelial attachment in unhealthy gingival tissue. The pocket depth usually consists of depths great than 3 mm. pocket.
Measured: Baseline, 6 weeks, and 12 weeks
Secondary outcomes (2)
Intraoral Photos
Photos taken of the teeth, gums, and oral tissue. These may be a single tooth, a group of teeth, or any area of the mouth. Intraoral photos help establish a baseline for all dental conditions and are used as a tool to monitor any recession or suspicious lesions.
Measured: Baseline, 6 weeks, and 12 weeks
MyPerioPath®
Used test for the detection of oral pathogens that cause gum disease and threaten oral \& systemic health. It provides early warning of oral pathogens to enable the personalization of periodontal treatment. This test is non-invasive oral rinse collection (OralDNA® Labs)
Measured: Baseline, 6 weeks, and 12 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Apr 2024
- Study start10 Jul 2024
- Primary completionJul 2025 (estimated)
- Study completionAug 2025 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oral HealthStudies 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
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- The proposed study is a 12-week pilot study of PerioPull™. Eligible participants will be recruited from within the clinical practice of the periodontist. All study outcomes will be measurements and testing during three dental visits spaced 6 weeks apart. These are typical assessments in routine clinical practice. All study outcomes are described in detail in an ensuing section.
- Masking
- None (open label)
- Enrolment
- 18 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Designs for Health
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06363721
- Sponsor's protocol ID
- DFH00125
- Status last verified
- May 2025
- First submitted
- 9 Apr 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- 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 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Pilot Study of a Commercially-available Oil Rinse Product (PerioPull™) on Markers of Dental Health
- ClinicalTrials.gov ID
- NCT06363721
- Acronym / sponsor ID
- DFH00125
- Conditions
- Oral Health
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 18 participants (estimated)
- Lead sponsor
- Designs for HealthIndustry (pharma, biotech, devices)
- Study start
- 10 Jul 2024 (actual)
- Primary completion
- Jul 2025 (estimated)
- Study completion
- Aug 2025 (estimated)
- First posted
- 12 Apr 2024 (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 primary purpose of this study is to evaluate the impact of a commercially-available oil rinse product (PerioPull™) on parameters of dental health among a sample of adults. PerioPull™ is commercially available and sold primarily from clinicians' offices.
A 12-week pilot study will be conducted to achieve the purpose of this study. The research team hypothesizes that PerioPull™ will improve a variety of validated markers of dental health that are commonly used in clinical practice.
Detailed description
Patients that suffer from dental health issues often have a deeper than normal pocket depth. These pockets can become filled with infection causing bacteria causing inflammation around the tooth leading to periodontal disease.
The current recommendations are to brush with Sensodyne, use a special mouthwash, do not brush as hard, or use an electric toothbrush.
PerioPull™ is a natural oil rinse formula to support overall oral/gum health, tooth stains, and natural teeth whitening. This formula contains specific nutrients that have been previously studied and shown to be efficacious in oral health These actions do not have any known side effects, which present an advantage over standard dental treatments with fluoride, chlorhexidine, hydrogen peroxide and other chemicals.
This oil rinse formula is a commercially available product sold primarily from physicians' offices. As indicated in the ingredient list provided below, PerioPull™ includes Medium Chain Triglycerides (C8, C10, C12) (from coconut oil), Bixa orellana (Annatto) Seed Extract (GG-Gold®), Natural Mint Flavor, Bromelain, Ubiquionone, Delta Tocotrienols.
The proposed study is a 12-week pilot study of PerioPull™. Eligible participants will be recruited from within the clinical practice of the periodontist.
Study outcomes will consist of parameters of dental health among a sample of adults. These outcomes will be collected during a dental visit and assessed at baseline, six weeks, and at the conclusion of the 12-week clinical trial.
Oral samples that are obtained during clinical visits will be sent to lab utilized by participating clinical practices for analysis of study outcomes.
The outcomes in this clinical trial have been studied in previous clinical trials among dental patients. One oral sample at each of the three study visits is all that is required to collect outcomes.
All study outcomes will be measurements and testing during three dental visits spaced 6 weeks apart. These are typical assessments in routine clinical practice.
Study design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- The proposed study is a 12-week pilot study of PerioPull™. Eligible participants will be recruited from within the clinical practice of the periodontist. All study outcomes will be measurements and testing during three dental visits spaced 6 weeks apart. These are typical assessments in routine clinical practice. All study outcomes are described in detail in an ensuing section.
| Arm | Type | Receives |
|---|---|---|
| PerioPull™ | Experimental | Dietary Supplement: PerioPull™Participants will swish 1 teaspoon (approx. 5 mL) of oil in the mouth for a minimum of 5 minutes after their normal brushing routine, as is suggested on the label of the bottle. They will spit out the oil and not rinse to allow for longer contact to the teeth and gums. This will be once a day for 12 weeks. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Plaque index of at least 1
- Gingival index of at least 1
- Pocket depth no greater than 5 mm
- Able to understand and write English
- Voluntarily consent to the study and understand its nature and purpose including potential risks and side effects
Key exclusion criteria (7 listed)
- Current daily use of any products containing the nutrients and/or herbs in the study product
- Known allergies to any substance in the study product
- Current daily tobacco smoker
- Currently pregnant or lactating women or women planning to become pregnant in the next 12 weeks
- Active oral infection (ie. herpes, candida)
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 |
|---|---|---|
| PerioPull™PerioPull™ is a natural oil rinse formula to support overall oral/gum health, tooth stains, and natural teeth whitening. PerioPull™ includes Medium Chain Triglycerides (C8, C10, C12) (from coconut oil), Bixa orellana (Annatto) Seed Extract (GG-Gold®), Natural Mint Flavor, Bromelain, Ubiquinone, Delta Tocotrienols. | Dietary supplement | PerioPull™ |
Primary outcome
Plaque Index
Time frame: Baseline, 6 weeks, and 12 weeks
Assesses the amount of dental plaque visible on the vestibular and lingual surfaces of all teeth, except the third molars. The bacterial plaque developer solution was used to define cumulative amounts of plaque with criteria from 0 to 5. Once the values of the individual teeth are recorded, they are added and divided by the number of teeth examined to obtain the plaque index of each patient.
Gingival Index
Time frame: Baseline, 6 weeks, and 12 weeks
A method of recording the clinical severity of gingival inflammation. It is based upon probe measurement of periodontal pockets and on gingival tissue status.
Pocket Depth
Time frame: Baseline, 6 weeks, and 12 weeks
A measurement in millimeters of the depth from the gingival margin to the epithelial attachment in unhealthy gingival tissue. The pocket depth usually consists of depths great than 3 mm. pocket.
2 secondary outcomes
Intraoral Photos
Time frame: Baseline, 6 weeks, and 12 weeks
MyPerioPath®
Time frame: Baseline, 6 weeks, and 12 weeks
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PerioPull™ in people with Oral Health, run by Designs for Health at 1 site in United States.
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 7 inclusion and 7 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: looking for participants now, as of the sponsor's last update on 14 May 2025. 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 United States. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Michael Jurgelewicz, DC (860-752-7443, drj@designsforhealth.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Plaque Index (time frame: Baseline, 6 weeks, and 12 weeks). The study lists 3 primary outcomes in all. 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 14 May 2025.