Clinical trial NCT06984744: 4-day Plaque Accumulation Model Evaluating Compound Containing Gum
Official title: Effect of an Active Compound Containing Gum on Dental Plaque Formation on a 4-day Accumulation Model
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Dental Plaque Accumulation
Keywords: dental plaque
gum chewing
Lead sponsor: Lactea Therapeutics, LLC
Sponsor class: INDUSTRY
Collaborators: name: Indiana University
name: Oral Health Research Institute, Indiana University School of Dentistry
First posted: 2025-05-22
Enrollment: 32
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Intervention model description: Subjects who previously participated in other Oral Health Research Institute studies (OHRI) or who have contacted OHRI expressing interest in potential studies will be contacted by a team member who will conduct a screening phone interview. If the potential subjects appear to qualify, they will be scheduled for the screening visit.

A sufficient number of subjects will be screened to participate, and 32 will be randomized to finish with at least 30 subjects. We intend to randomize a nearly equal number of female and male subjects. A unique screening number will identify all subjects screened for study participation. Screening numbers will be assigned according to appearance at the study site. Subjects who meet all inclusion and exclusion criteria will be randomized into the study. Block randomization will be used to assign subjects to one of the three treatment regimen sequences:

1. Control regimen (Tx 3) followed by experimental regimen (Tx 1), followed by a negative control (Tx 2), or
Primary purpose: PREVENTION

Brief 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).

Detailed description: 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). Each subject will be assigned to one of the following three treatment regimen sequences:

1. Control regimen followed by experimental regimen, followed by a negative control regimen, or
2. Experimental regimen followed by negative control regimen, followed by control regimen or
3. Negative control regimen followed by control regimen, followed by an experimental regimen Subjects will be asked to refrain from oral hygiene (OH) procedures and chewing gum 12 hours (+/- 2 hours) and from eating or drinking (except for water) 2 hours prior to the screening visit. During the 4-day study treatment periods, subjects will also be asked to refrain from oral hygiene practices or any elective dental treatment. Subjects can resume their regular oral hygiene procedures during the wash-out periods of approximately 10 days.

At the screening, potential subjects will be given the IRB (Institutional Review Board)-approved informed consent form to read and ask questions. Also, adequate time to decide about their participation will be provided. A study representative trained and delegated by the Principal Investigator will review the IRB-approved consent and answer any questions the potential subject might have before the subject signs/dates the consent. After the subject signs and dates the consent, the study representative will sign and date the consent to confirm that the consent process was completed before initiating any study procedures. The subject will be given a copy of the signed/dated consent.

A designated staff member will collect the medical and concomitant medication information for the study dentist's review. The dentist will perform an oral examination and a PLI to assess the subject's whole-mouth plaque accumulation. A score of 2 or greater will be needed to comply with the study inclusion criteria based on the Turesky modification of the Quigley and Hein Plaque Index (PLI). Other dental characteristics specified on the inclusion/ exclusion criteria will be assessed to determine study eligibility. Eligible subjects will receive a dental prophylaxis and be scheduled for a baseline appointment.

During the baseline appointment, the subjects' continuance criteria and OST (oral specimen test) examination will be assessed, and an unstimulated saliva sample will be collected. Subjects' teeth will be polished, flossed, and subsequently stained to evaluate total plaque removal and an oral assessment will be performed to confirm the complete removal of plaque. If any plaque is found, the plaque will be removed by either flossing, repolishing the surface, or with an instrument. The dental examiner will assess PLI. Intraoral photos will be taken, including one front and two lateral images (right and left side). 32 subjects will be enrolled and randomly assigned to one of the treatment regimens. Subjects assigned to experimental and negative treatment regimens will perform the first product use under supervision.

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.

The last product-use treatment will be after dinner the day before the visit. Subjects will refrain from eating or drinking (except water) for two hours before their appointment. They will also be asked to rinse their mouths with water approximately 30 minutes before their visit.

During the end of the treatment visit, subjects' continuance criteria will be assessed; the diary will be reviewed for compliance; an OST exam will be performed; and an unstimulated saliva sample will be collected. Subjects will rinse with a disclosing solution to reveal the accumulation of dental plaque. Intraoral photos, including one front and two lateral images (right and left sides), will be taken. Afterward, the examiner will assess the PLI, and subjects will be taken to a brushing station to brush their teeth using a provided toothbrush, fluoride-containing toothpaste, and dental floss. They will be scheduled for the next visit after a washout period of approximately 10 days.

For treatments 2 and 3, the procedures mentioned in the baseline visit will be repeated (except for randomization). A new product (or no product) will be given according to the randomization assignment. The end of the treatment visit will be repeated on the fourth day of each treatment period.

Lactea Therapeutics has formulated a gum product containing an active innate immune protein, MIIP-E2. This product is an ultrapure (\>99%) fully native and completely active form of bovine lactoferrin extracted and purified directly from raw milk. MIIP-E2 aims to develop a field-deployable dental care solution to enhance on-the-go oral care targeting military use. Due to the capability of the MIIP-E2 gum to coat the inner surfaces of the mouth, it can function as a barrier to biofilm adherence. The dosage of MIIP-E2 proposed for use in this study is dramatically below these acceptable levels in milk-based infant formulas, which range between 101.3 and 60.1 mg daily.

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

Primary outcomes:
measure: dental plaque
timeFrame: At the end of 4 days of intervention.
Secondary outcomes:
measure: 16S sequencing
timeFrame: At the end of 4 days of intervention.
measure: Dental Plaque Visual Assessment with photographs
timeFrame: At the end of 4 days of intervention.
Other outcomes:
Locations:
city: Indianapolis
country: United States
facility: Oral Health Research Institute
state: Indiana
Study officials:
affiliation: Oral Health Research Institute Indiana University
name: Ana G Gossweiler, DDMSD
role: PRINCIPAL_INVESTIGATOR
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