Oral Probiotic + Toothpaste for Oral Hygiene

Overseen By Man Hung (Primary Investigator), PhD

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: USANA Health Sciences

Must not be taking: Probiotics, Antibiotics, Antifungals, Antiseptics

Disqualifiers: Pregnancy, Alcohol, Marijuana, Tobacco, others

Compensation: Varies

Number of Visits: Unknown

Duration: 8 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests the safety and effectiveness of an oral probiotic, with or without a special toothpaste, to determine if they improve gum health compared to a placebo. It targets individuals with mild to moderate gingivitis, characterized by gum inflammation and bleeding. Participants must attend several clinic appointments and follow oral hygiene instructions. As an unphased trial, this study provides a unique opportunity to advance dental health research.

Will I have to stop taking my current medications?

Yes, if you are currently taking oral probiotics, antibiotics, antifungal medications, antiseptic medications, immunosuppressants, chemotherapeutic medications, or certain medications that affect gum response, you will need to stop taking them at least 30 days before joining the trial.

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

Research has shown that the oral probiotic lozenges used in this trial are generally safe. Studies have found that these lozenges do not damage DNA or cause poisoning from short- or medium-term use. The specific strain, K12, in these lozenges has not been linked to any harmful effects when used as directed.

The ADP-1 toothpaste is also considered safe. ADP-1, a type of bacteria found in 98% of healthy people's dental plaque, does not produce harmful substances. Both the probiotic lozenges and ADP-1 toothpaste have shown potential in supporting oral health without significant safety concerns reported. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Researchers are excited about these treatments because they are exploring new ways to improve oral health using probiotics and a novel toothpaste formula. Unlike traditional toothpaste that primarily focuses on mechanical cleaning and fluoride, the novel ADP-1 toothpaste combines with probiotics to potentially enhance the oral microbiome. This approach aims to promote beneficial bacteria while reducing harmful ones, offering a more natural way to maintain oral health. The use of oral probiotic lozenges is also a fresh method, providing beneficial bacteria directly to the mouth, which could offer a more targeted and effective approach compared to standard mouthwashes or toothpaste.

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

Research shows that oral probiotics can improve oral health by using beneficial bacteria to combat harmful germs. Studies have found that these probiotics can reduce the depth of gum pockets, indicating healthier gums. In this trial, one group of participants will receive oral probiotic lozenges with ADP-1 toothpaste, which may offer enhanced benefits due to its special bacteria that improve oral health. Participants using probiotics with ADP-1 toothpaste have achieved better results than those using regular toothpaste. Another group will receive oral probiotics with a placebo toothpaste, which may still offer benefits, such as reduced tooth decay in children at low risk. Overall, both treatments in this trial appear promising for improving oral health. ^{6 7 8 9 10}

Are You a Good Fit for This Trial?

Inclusion Criteria

Have mild to moderate gingivitis (i.e., probing depth between 3mm and 5mm)

Able to perform oral hygiene adequately after formal instructions

Able to understand and comply with study procedure

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive oral probiotic intervention with or without a novel ADP-1 toothpaste

8 weeks

Regular visits for treatment and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Oral probiotic
• Placebo

How Is the Trial Designed?

Group I: : Oral probiotic lozenges + placebo toothpaste (toothpaste without ADP-1) Experimental Treatment 2 Interventions

1 active oral probiotic with placebo toothpaste

Group II: Oral probiotic lozenges + toothpaste with ADP-1 Active Control 1 Intervention

Oral probiotic and ADP1 toothpaste

Group III: Placebo lozenges (lozenges without oral probiotics) + placebo toothpaste (toothpaste without ADP-1) Placebo Group 1 Intervention

Placebo without oral probiotics or ADP1 toothpaste

Who Is Running the Clinical Trial?

USANA Health Sciences

Lead Sponsor

Trials

12

Recruited

760+

Roseman University of Health Sciences

Collaborator

Trials

5

Recruited

600+

Published Research Related to This Trial

A systematic review of 57 clinical studies found that probiotics and synbiotics are safe for immune-compromised adults, with no serious adverse events linked to these products, indicating they are well tolerated.

Probiotics and synbiotics resulted in fewer adverse events compared to control groups, but the study highlighted issues with inconsistent reporting of adverse events, suggesting a need for standardized reporting to enhance data reliability.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

The administration of probiotics and synbiotics in immune compromised adults: is it safe? Van den Nieuwboer, M., Brummer, RJ., Guarner, F., et al.[2014]

In a study involving 77 patients with chronic inflammatory rhinosinusitis, the probiotic Lactobacillus rhamnosus R0011 showed a significant improvement in quality of life at 4 weeks, but this effect did not persist at 8 weeks.

Overall, there were no significant differences in quality of life improvements or symptom frequency between the probiotic and placebo groups, indicating that the probiotic did not provide a meaningful benefit over placebo in this patient population.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Probiotics as adjunctive treatment for chronic rhinosinusitis: a randomized controlled trial. Mukerji, SS., Pynnonen, MA., Kim, HM., et al.[2022]

Probiotics are widely used, with over 20 billion doses taken annually, and are generally considered safe with very few serious side effects reported.

There is a need for standardized criteria to define what qualifies as a 'probiotic' to ensure products meet safety and efficacy standards, especially as new products enter the market.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Safe and efficacious probiotics: what are they? Reid, G.[2007]

Probiotics have a long history of safe use, and while clinical trials generally show no increased risk, the current literature lacks comprehensive safety reporting, making it difficult to draw definitive conclusions about their safety in intervention studies.

Theoretical risks associated with probiotics include systemic infections and gastrointestinal side effects, highlighting the need for further research to accurately assess the incidence and severity of any adverse events related to their use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Risk and safety of probiotics. Doron, S., Snydman, DR.[2022]

Citations

1.

clinicaltrials.gov

clinicaltrials.gov/study/NCT05330793

The Effects of an Oral Probiotic Intervention With or Without ...

Subjects using oral probiotics and ADP-1 toothpaste will have better oral health than subjects using oral probiotics and regular toothpaste, and subjects using ...

2.

withpower.com

withpower.com/trial/phase-oral-health-9-2021-92887

The Effects of an Oral Probiotic Intervention With or Without ...

The oral probiotic treatment is unique because it uses beneficial bacteria to potentially improve health outcomes, unlike traditional treatments that may rely ...

3.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/38297088/

and probiotics a valuable adjunct to fluoridated toothpaste ...

Conclusions: The use of a probiotic and prebiotic daily lozenges as an adjunct to 1450 ppm fluoride toothpaste and oral hygiene instruction did ...

4.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC5344910/

Health-Associated Niche Inhabitants as Oral Probiotics

We hypothesize that oral inhabitants associated to health conditions will be more effective than traditional, gut-associated probiotic species ...

5.

frontiersin.org

frontiersin.org/journals/oral-health/articles/10.3389/froh.2025.1668943/epub

The efficacy of lactic acid bacteria-based toothpaste on oral ...

This systematic review and meta-analysis aimed to assess the effectiveness of LAB-based toothpaste in improving oral health outcomes.

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC1449041/

Safety Assessment of the Oral Cavity Probiotic ...

In this report we document safety data relating to S. salivarius K12, including assessment of its antibiogram, metabolic profiles, and virulence determinants.

7.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/26781236/

Extended Safety Data for the Oral Cavity Probiotic ...

The various sets of data obtained in this study showed no evidence of genotoxicity and no acute or subacute toxicity effects associated with strain K12. Based ...

8.

maxill.com

maxill.com/ca/mwdownloads/download/link/id/1338/

SAFETY DATA SHEET Smart Mouth Lozenges

Eyes. There is no known adverse effect from exposure to the recommended use of this product. Skin. There is no known adverse effect from ...

9.

clinicaltrials.gov

clinicaltrials.gov/study/NCT06380270

Evaluation of Safety and Human Tolerance of Oral ...

Evaluation of Safety and Human Tolerance of Oral Probiotic Streptococcus Salivarius eK12. ClinicalTrials.gov ID NCT06380270.

10.

onlinelibrary.wiley.com

onlinelibrary.wiley.com/doi/10.1111/odi.13854

Lozenges with probiotic strains enhance oral immune ...

Overall, our clinical study suggests that oral probiotic lozenges may enhance oral immunity, modulate oral microbiota, and improve oral health.