4-day Plaque Accumulation Model Evaluating Compound Containing Gum
Effect of an Active Compound Containing Gum on Dental Plaque Formation on a 4-day Accumulation Model
Lactea Therapeutics, LLC
32 participants
Jun 23, 2025
INTERVENTIONAL
Conditions
Summary
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).
Eligibility
Inclusion Criteria6
- 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 Criteria13
- 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
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Interventions
Each subject will be instructed to refrain from using any oral dental hygiene procedures during the study treatment period (4 days). Subjects assigned to the experimental and negative treatment regimen will use only the provided gum product three times a day for 10 minutes after meals (breakfast, lunch, and dinner). Starting on one side of the mouth, chewing for 1 minute, and switching to the other side for another minute. Afterward, they continue chewing for the remaining time however they like. To assess compliance, each subject assigned to a chewing gum product will be provided a diary to record every time they use the product and record any events associated with their study participation. Finally, subjects will be scheduled to return for an end-of-regimen visit. MIIP-E2 is an ultrapure (\>99%) fully native and completely active form of bovine lactoferrin purified directly from raw milk.
Each subject will be instructed to refrain from using any oral dental hygiene procedures during the study treatment period (4 days). Subjects assigned to the experimental and negative treatment regimen will use only the provided gum product three times a day for 10 minutes after meals (breakfast, lunch, and dinner). Starting on one side of the mouth, chewing for 1 minute, and switching to the other side for another minute. Afterward, they continue chewing for the remaining time however they like. To assess compliance, each subject assigned to a chewing gum product will be provided a diary to record every time they use the product and record any events associated with their study participation. Finally, subjects will be scheduled to return for an end-of-regimen visit.
Locations(1)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT06984744