A Pilot Study of a Commercially-available Oil Rinse Product (PerioPull™) on Markers of Dental Health
ConditionOral Health
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18+
SponsorDesigns for Health
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Single group
Treatments tested in this trial
PerioPull™
Dietary supplementPerioPull™ 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.
Treatment groups
18 Participants
are divided into 1 treatment groupGroup A: PerioPull™Experimental treatment 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline, 6 weeks, and 12 weeks2
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.
Time frame
Baseline, 6 weeks, and 12 weeks3
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.
Time frame
Baseline, 6 weeks, and 12 weeksSecondary outcomes
1
Intraoral Photos
Photos taken of the teeth, gums, and oral tissue. These may be a single tooth, a group of teeth, or any area of the mouth. Intraoral photos help establish a baseline for all dental conditions and are used as a tool to monitor any recession or suspicious lesions.
Time frame
Baseline, 6 weeks, and 12 weeks2
MyPerioPath®
Used test for the detection of oral pathogens that cause gum disease and threaten oral \& systemic health. It provides early warning of oral pathogens to enable the personalization of periodontal treatment. This test is non-invasive oral rinse collection (OralDNA® Labs)
Time frame
Baseline, 6 weeks, and 12 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov