Clinical trial NCT06363721: A Pilot Study of a Commercially-available Oil Rinse Product (PerioPull™) on Markers of Dental Health
Official title: A Pilot Study of a Commercially-available Oil Rinse Product (PerioPull™) on Markers of Dental Health
Study type: INTERVENTIONAL
Overall status: RECRUITING
Phase: NA
Conditions: Oral Health
Lead sponsor: Designs for Health
Sponsor class: INDUSTRY
First posted: 2024-04-12
Enrollment: 18
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: SUPPORTIVE_CARE

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.

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.

Eligibility criteria: 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)

Primary outcomes:
measure: Plaque Index
timeFrame: Baseline, 6 weeks, and 12 weeks
measure: Gingival Index
timeFrame: Baseline, 6 weeks, and 12 weeks
measure: Pocket Depth
timeFrame: Baseline, 6 weeks, and 12 weeks
Secondary outcomes:
measure: Intraoral Photos
timeFrame: Baseline, 6 weeks, and 12 weeks
measure: MyPerioPath®
timeFrame: Baseline, 6 weeks, and 12 weeks
Other outcomes:
Locations:
city: Ellicott City
country: United States
facility: Julian Center for Comprehensive Dentistry
state: Maryland
Study officials:
References: