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

Results pending

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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Recruitment Status

RECRUITING

Clinical Phase

NA

Total Enrollment

18 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-07-10

Study Completion Date

2025-08-31

Brief Summary

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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

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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

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Oral Health

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

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.
Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

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.

Group Type EXPERIMENTAL

PerioPull™

Intervention Type 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.

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.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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Inclusion Criteria

* 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

Exclusion Criteria

* 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)
Minimum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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Designs for Health

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Julian Center for Comprehensive Dentistry

Ellicott City, Maryland, United States

Site Status RECRUITING

Countries

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United States

Central Contacts

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Michael Jurgelewicz, DC

Role: CONTACT

860-752-7443

Chris D'Adamo, PhD

Role: CONTACT

410-706-6165

Facility Contacts

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Eugene Sambataro, DDS

Role: primary

410-834-0796

Other Identifiers

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DFH00125

Identifier Type: -

Identifier Source: org_study_id

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