Experimental Gum for Oral Plaque

Overseen By Lorena Galvez

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Lactea Therapeutics, LLC

Must not be taking: Antibiotics

Disqualifiers: Periodontitis, Orthodontic appliances, Pregnancy, others

Compensation: Varies

Number of Visits: 5

32 Participants Needed

Trial Summary

What is the purpose of 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).

Research Team

Ana G Gossweiler, DDMSD

Principal Investigator

Oral Health Research Institute Indiana University

Eligibility Criteria

This trial is for people with a plaque level of 2 or higher, who are healthy with at least 20 natural teeth and willing to follow study procedures. They can't have used antibiotics in the last month, be pregnant or breastfeeding, have participated in similar studies recently, work on this study, have severe oral issues or allergies to certain products.

Inclusion Criteria

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 read and sign the IRB-approved informed consent

Healthy, as determined by pertinent medical history at the study dentist's discretion

Exclusion Criteria

I have not taken antibiotics in the last 30 days and will not during the study.

Self-reported pregnant, wanting to get pregnant, or breast-feeding female

Subject who has previously been randomized in this study

Timeline

Screening

Participants are screened for eligibility to participate in the trial

1 day

1 visit (in-person)

Baseline

Baseline appointment where subjects' continuance criteria and OST examination are assessed, and an unstimulated saliva sample is collected

1 day

1 visit (in-person)

Treatment Period 1

Subjects undergo the first treatment regimen for 4 days, using the assigned gum product or no gum, and refrain from oral hygiene practices

4 days

1 visit (in-person) at the end of the period

Washout Period 1

Subjects resume regular oral hygiene procedures during a washout period

10 days

Treatment Period 2

Subjects undergo the second treatment regimen for 4 days, using the assigned gum product or no gum, and refrain from oral hygiene practices

4 days

1 visit (in-person) at the end of the period

Washout Period 2

Subjects resume regular oral hygiene procedures during a washout period

10 days

Treatment Period 3

Subjects undergo the third treatment regimen for 4 days, using the assigned gum product or no gum, and refrain from oral hygiene practices

4 days

1 visit (in-person) at the end of the period

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• MIIP-E2 gum

Trial Overview The trial tests an experimental gum against a placebo and no-gum control over three periods of four days each. It's single-blind (participants don't know which treatment they get), comparing the effects on dental plaque accumulation.

Participant Groups

Group I: Intervention Experimental MIIP-E2 regimen Experimental Treatment 1 Intervention

Gum will contain gum base with 30mg of compound being evaluated. Gum will contain gum base only without compound being evaluated. 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.

Group II: Control regimen Active Control 1 Intervention

Subjects will chew no gum during this regimen. 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). Subjects in the no intervention regimen will use no gum. 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.

Group III: Negative control regimen Placebo Group 1 Intervention

Gum will contain gum base only without compound being evaluated. 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.

Who Is Running the Clinical Trial?

Lactea Therapeutics, LLC

Lead Sponsor

Indiana University

Collaborator

Trials

1,063

Recruited

1,182,000+

Oral Health Research Institute, Indiana University School of Dentistry

Collaborator