Oral Health Clinical Trial
Official title:
A Pilot Study of a Commercially-available Oil Rinse Product (PerioPull™) on Markers of Dental Health
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.
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. ;
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