Recruiting

PerioPull™

Sponsor:

Designs for Health

Code:

NCT06363721

Conditions

Oral Health

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

Interventions

PerioPull™

Study Details

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

Study ID

NCT06363721

Start date

Jul 10, 2024

Status verified date

May, 2025

Completion date

Aug, 2025

Anticipated

Primary completion date

Jul, 2025

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Accepted

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)

Study Design

Enrollment

18 participants

Anticipated

Intervention Model

Single group

Primary purpose

Supportive Care

Interventions and Outcome Measures

Arms

experimental: 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.

Interventions

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.

Primary outcome measure

  • Plaque Index [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
  • Gingival Index [ Time Frame: Baseline, 6 weeks, and 12 weeks ]
  • Pocket Depth [ Time Frame: Baseline, 6 weeks, and 12 weeks ]

Central Contacts and Locations

Central contacts

Michael Jurgelewicz, DC

860-752-7443drj@designsforhealth.com

Chris D'Adamo, PhD

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

Locations

Julian Center for Comprehensive Dentistry

Recruiting

Ellicott City, Maryland, United States, 21042

Contacts

Eugene Sambataro, DDS

410-834-0796drsam@julianctr.com

Principal Investigator:

Eugene Sambataro, DDS

More Information

Sponsor

Designs for Health

Last update posted

May 14, 2025

Last verified

May, 2025

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Designs for Health on 2025-05-14.