๐ฌIn plain words
What the trial is, and whether it could suit you
This will be a single-blind, single-center, 3-way crossover, randomized controlled clinical trial with 3 treatment periods utilizing 32 subjects. (Fig 1, in protocol) Each treatment period will be 4 days (96 hours +/-3 hours) in accordance with the plaque accumulation model using one of the following treatment groups: an active compound MIIP-E2 gum (experimental regimen), an inactive compound gum (negative control regimen), and a no-gum (control regimen).
Sign in to get the eligibility rules as simple questions to take to your doctor.
๐ Eligibility rules (as published)
Inclusion Criteria:
* Adult subjects between 18 and 65 years old
* Willing to read and sign the IRB-approved informed consent.
* Healthy, as determined by pertinent medical history at the study dentist's discretion.
* A minimum of 20 natural teeth (excluding third molars) with at least two scorable surfaces per tooth (teeth with full crowns, large/extensive restorations on the interproximal areas, and orthodontic bands will not be included in the tooth count)
* PLI of 2 or greater (Based on the Turesky modification of the Quigley and Hein Plaque Index) calculation based on a whole mouth plaque score.
* Willing to comply with the study procedures.
Exclusion Criteria:
* Presence of any acute or chronic condition, organ system disease, or medication that, in the principal investigator's opinion, could compromise the subjects' ability to participate in the study.
* Gross oral pathologies, including caries, calculus, or soft tissue conditions that show evidence of chronic neglect.
* Evidence of acute periodontal conditions or periodontitis with pockets greater than 5 mm on more than one site
* Use of antibiotics 30 days prior to or during the study
* Requiring the need for antibiotic premedication prior to dental procedures
* Sensitivity to bovine products (lactoferrin) or any of the listed inactive ingredients
* Orthodontic appliances or any removable, except lingual bar retainers
* Self-reported pregnant, wanting to get pregnant, or breast-feeding female,
* Self-reported allergy to disclosing solution ingredients (red dye #28)
* Acute Temporomandibular Disorders (TMD)
* Subject who has participated in other studies (including non-medicinal studies) involving product(s) within 30 days before study screening.
* Subject who has previously been randomized in this study
* An employee of the study site directly involved with the study
๐
What it tests
- MIIP-E2 containing gum
- placebo gum without MIIP-E2
Oral Health Research Institute
Indianapolis, United States
๐ค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ always decide together with your own doctor.