A Pilot Study of a Commercially-available Oil Rinse Product (PerioPull™) on Markers of Dental Health
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Sponsor
- Enrollment
- 18
- Locations
- 1
- Primary Endpoint
- Gingival Index
Study Overview
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 Design
- Study Type
- Interventional
- Allocation
- Na
- Intervention Model
- Single Group
- Primary Purpose
- Supportive Care
- Masking
- None
Eligibility Criteria
- Ages
- 18 Years to — (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
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)
Arms & Interventions
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.
Intervention: PerioPull™ (Dietary Supplement)
Outcomes
Primary Outcomes
Gingival Index
Time Frame: Baseline, 6 weeks, and 12 weeks
A method of recording the clinical severity of gingival inflammation. It is based upon probe measurement of periodontal pockets and on gingival tissue status.
Pocket Depth
Time Frame: Baseline, 6 weeks, and 12 weeks
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.
Plaque Index
Time Frame: Baseline, 6 weeks, and 12 weeks
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.
Secondary Outcomes
- Intraoral Photos(Baseline, 6 weeks, and 12 weeks)
- MyPerioPath®(Baseline, 6 weeks, and 12 weeks)