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4-day Plaque Accumulation Model Evaluating Compound Containing Gum

ConditionDental Plaque Accumulation
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorLactea Therapeutics, LLC

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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)

Disqualifiers

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

Trial design

Design model

Crossover

Treatments tested in this trial

  • MIIP-E2 containing gum

    Device

    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.

  • placebo gum without MIIP-E2

    Device

    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.

Treatment groups

32 Participants
are divided into 3 treatment groups
Group A: Control regimenNo intervention 0 interventions
Group B: Intervention Experimental MIIP-E2 regimenExperimental treatment 1 intervention
Group C: Negative control regimenPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

dental plaque

Dental plaque was identified using a disclosing solution and scored using the Turesky modification of the Quigley-Hein Plaque Index (PLI). The index score was scored between 0 and 5, with 0 = no plaque detected and 5= = Plaque covering 2/3 or more of the tooth's crown. The remaining values are based on the amount of plaque covering the tooth. The higher the score, the more plaque accumulated and the worse the outcome for the surface. Each tooth, except the third molars, will be scored at six sites: Mesio-Buccal, buccal, disto-buccal, mesio-lingual, lingual, and disto-lingual. The plaque score index for an individual is determined by adding all the individual scores and dividing the total score by the number of surfaces examined. A score would range from 0.1 to 3.0 (0.1-1.0= = mild inflammation; 1.1-2.0= = moderate inflammation; and 2.1-3.0= = severe inflammation).

Time frame
At the end of 4 days of intervention.

Secondary outcomes

1

16S sequencing

In addition, patient saliva samples will be taken before and after each treatment regimen for 16S rRNA (ribosomal ribonucleic acid) microbiome sequencing using the Qiagen PAXgene Saliva Collector and protocols that accompany the collection kit (https://www.qiagen.com /us/products/discovery-and-translational-research/sample-collection-stabilization/dna/pax gene-saliva-collector). Sequencing will be performed at CD Genomics (a third-party vendor) using protocols for full-length PacBio (Pacific Biosciences) sequencing and IRB#: 25945 Version Date: February 3, 2025 Page 6 of 18 analyzed using standard methodologies to identify microbial taxonomy. No human genetic information will be collected or analyzed using this methodology.

Time frame
At the end of 4 days of intervention.
2

Dental Plaque Visual Assessment with photographs

Images of dental plaque will be used for both qualitative representations of outcomes in future reports as well as used as a secondary, complementary quantitative analysis for the PLI assessment. For the quantitative analysis, plaque coverage on teeth will be assessed using an image thresholding area measurement as previously described. This analysis is anticipated to provide similar results to the PLI as mentioned earlier but may allow for further analysis and quantitative precision. Depending on preliminary analysis, these measurements may be used to further assess details of product efficacy, such as regional changes in plaque across teeth, to understand whether the reduction in plaque occurred primarily on surfaces with direct exposure to the gum or throughout the mouth.

Time frame
At the end of 4 days of intervention.

Other outcomes

Sponsors and contacts

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Lactea Therapeutics, LLC

Lead sponsor

Indiana University

Collaborator

Source ClinicalTrials.gov
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