A Pilot Study of a Commercially-available Oil Rinse Product (PerioPull™) on Markers of Dental Health
NCT ID: NCT06363721
Last Updated: 2025-05-14
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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RECRUITING
NA
18 participants
INTERVENTIONAL
2024-07-10
2025-08-31
Brief Summary
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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.
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Detailed Description
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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
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Study Design
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NA
SINGLE_GROUP
SUPPORTIVE_CARE
NONE
Study Groups
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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.
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.
Interventions
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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.
Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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)
18 Years
ALL
Yes
Sponsors
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Designs for Health
INDUSTRY
Responsible Party
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Locations
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Julian Center for Comprehensive Dentistry
Ellicott City, Maryland, United States
Countries
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Central Contacts
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Facility Contacts
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Other Identifiers
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DFH00125
Identifier Type: -
Identifier Source: org_study_id
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