4-day Plaque Accumulation Model Evaluating Compound Containing Gum

Launched by LACTEA THERAPEUTICS, LLC · May 14, 2025

Keywords

ClinConnect Summary

This clinical trial is investigating a new type of chewing gum designed to see if it can help reduce dental plaque, which is a sticky film of bacteria that forms on your teeth. The study will involve 32 adults who are between 18 and 65 years old, and they must have at least 20 natural teeth. Participants will take part in three different treatment periods, each lasting four days. They will chew either the experimental gum, a control gum with no active ingredients, or no gum at all to compare how well each option works in reducing plaque.

To join the study, participants need to be in good health and willing to follow the study's procedures. Some people won't be eligible, such as those with certain dental issues, recent antibiotic use, or specific medical conditions. This trial is not yet recruiting participants, but if you're interested, you can look for updates on when it will start. Overall, this study aims to give insights into how this new gum might help improve dental health by managing plaque accumulation.

Gender

ALL

Eligibility criteria

• 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