A Pilot Study of a Commercially-available Oil Rinse Product (PerioPull™) on Markers of Dental Health

NCT06363721 | Recruiting

• 1 other identifier: DFH00125
• Study Type: interventional
• Target: 18
• Locations: 1 country
• Sites: 1

Brief 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. 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.

Conditions

Oral Health

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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.

  Baseline, 6 weeks, and 12 weeks

Secondary Outcomes (2)

• Intraoral Photos

  Baseline, 6 weeks, and 12 weeks

• MyPerioPath®

  Baseline, 6 weeks, and 12 weeks

Study Arms (1)

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.

Dietary Supplement: PerioPull™

Interventions

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.

PerioPull™

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• Designs for Health: lead

Study Sites (1)

Julian Center for Comprehensive Dentistry

Ellicott City, Maryland, 21042, United States

RECRUITING

Central Study Contacts

Michael Jurgelewicz, DC

CONTACT

860-752-7443; drj@designsforhealth.com

Chris D'Adamo, PhD

CONTACT

410-706-6165; dadamo.scientific.consulting@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 9, 2024
• First Posted: April 12, 2024
• Study Start: July 10, 2024
• Primary Completion: July 1, 2025
• Study Completion: August 1, 2025
• Last Updated: May 14, 2025

Record last verified: 2025-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)