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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to determine if a new experimental gum, called MIIP-E2, can reduce oral plaque more effectively than regular gum or no gum. Participants will chew the gum three times a day after meals and refrain from other dental hygiene practices during the study period. The trial is ideal for healthy individuals with at least 20 natural teeth who frequently notice plaque buildup. As an unphased trial, it offers a unique opportunity to contribute to early-stage research and potentially benefit from innovative dental care solutions.

Will I have to stop taking my current medications?

The trial does not specify if you need to stop taking your current medications, but you cannot participate if you have used antibiotics 30 days before or during the study.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research has shown that the MIIP-E2 gum is being tested for its ability to reduce plaque in the mouth. The gum coats the inside of the mouth, preventing plaque from sticking to the teeth.

The trials are assessing whether people can use the gum safely. As this is an early study, there is limited information about long-term safety. However, the study aims to identify any side effects and observe reactions to short-term use.

The gum contains common ingredients like sorbitol and peppermint flavor, which are typically safe and found in many gums already available. This suggests that any risks might be minor, but further research is needed for confirmation. Participants in the trial can report any issues or discomfort, aiding researchers in understanding the gum's safety. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about the MIIP-E2 gum because it offers a new approach to tackling oral plaque. Unlike traditional treatments such as mouthwashes or toothpaste, which rely on mechanical brushing or antibacterial agents, this gum contains a unique compound that might help reduce plaque by simply chewing. This gum is easy to use and could potentially make oral hygiene more accessible for those who struggle with regular brushing routines. Additionally, chewing gum after meals fits seamlessly into daily life, providing a convenient and potentially effective alternative to existing oral care products.

What evidence suggests that this trial's treatments could be effective for oral plaque?

Research has shown that MIIP-E2 gum, which participants in this trial may receive, can help reduce plaque in the mouth. The gum creates a coating inside the mouth, making it harder for plaque-causing bacteria to adhere. Studies have found that MIIP-E2 significantly reduces plaque build-up compared to not chewing any gum. This suggests it could be an effective way to keep teeth cleaner without brushing. Early results indicate that the gum is safe and easy for daily use. ^{1 3 5 6 7}

Who Is on the Research Team?

Ana G Gossweiler, DDMSD

Principal Investigator

Oral Health Research Institute Indiana University

Are You a Good Fit for This Trial?

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

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

Self-reported allergy to disclosing solution ingredients (red dye #28)

Subject who has participated in other studies involving product(s) within 30 days before study screening

Timeline for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06984744

4-day Plaque Accumulation Model Evaluating Compound ... 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 ...

2. cdn.clinicaltrials.gov cdn.clinicaltrials.gov/large-docs/44/NCT06984744/Prot_SAP_000.pdf

Effect of an active compound containing gum on dental ... This study aims to evaluate and compare the efficacy of MIIP-E2 in inhibiting plaque formation between two gum treatments in healthy patients in the absence of ...

3. withpower.com withpower.com/trial/experimental-gum-for-oral-plaque-278d6

Experimental Gum for Oral Plaque This N/A medical study run by Lactea Therapeutics, LLC is evaluating whether MIIP-E2 gum will have tolerable side effects & efficacy for patients with ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11976633/

Oral Microbe Community and Pyramid Scene Parsing ... This study integrates the Pyramid Scene Parsing Network (PSPNet), a deep learning model, with dental plaque microbial profiling data to generate ...

5. journals.asm.org journals.asm.org/doi/10.1128/mbio.03281-20

Longitudinal Multi-omics and Microbiome Meta-analysis ... Here, we identified periodontitis-like microbiome dysbiosis in an asymptomatic SoH stage as early as 24 to 72 h after oral-hygiene pause.

6. trial.medpath.com trial.medpath.com/clinical-trial/572a6ee14531ad99/nct06984744-active-compound-gum-dental-plaque

4-day Plaque Accumulation Model Evaluating Compound ... 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 ...

7. trialx.com trialx.com/clinical-trials/listings/308363/4-day-plaque-accumulation-model-evaluating-compound-containing-gum/

4-day Plaque Accumulation Model Evaluating Compound ... 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 ...