Aquamin for Bad Breath

Overseen By Muhammad Nadeem Aslam

Age: 18+

Sex: Any

Trial Phase: Phase 2

Sponsor: University of Michigan

Must not be taking: Calcium, Vitamin D, NSAIDs, others

Disqualifiers: Pregnancy, Gastrointestinal disorders, Kidney disease, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

15 Participants Needed

Trial Summary

What is the purpose of this trial?

This trial is testing if Aquamin®, a mineral supplement from red seaweed, can help people with bad breath by improving their mouth health.

Will I have to stop taking my current medications?

If you are taking calcium, Vitamin D, oral steroids, NSAIDs, or antibiotics, you will need to stop them for 30 days before joining the trial.

How does the treatment Aquamin for bad breath differ from other treatments?

Aquamin is unique because it is derived from marine algae and is rich in minerals like calcium and magnesium, which may help neutralize odors and improve oral health, unlike traditional treatments that often focus on masking bad breath with flavors or killing bacteria with chemicals. ^{1 2 3 4 5}

Research Team

James Varani

Principal Investigator

University of Michigan

Janet Kinney

Principal Investigator

University of Michigan

Muhammad N Aslam

Principal Investigator

University of Michigan

Eligibility Criteria

This trial is for people with self-reported bad breath who are periodontally stable and can consent to study rules. They must not eat, drink, smoke, or use mouthwash an hour before visits and agree not to scrape their tongue during the study. Women must test negative for pregnancy and use birth control.

Inclusion Criteria

I believe I have bad breath.

Must be able to give written informed consent

Willing to follow study procedures of no eating, drinking, toothbrushing, smoking or using mouth rinse 60 minutes before study visits

Exclusion Criteria

I have been diagnosed with stomach or intestinal bleeding disorders recently.

I have not taken calcium, vitamin D, steroids, NSAIDs, or antibiotics in the last 30 days.

I have a bleeding disorder or am on blood thinners like Coumadin or heparin.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants take Aquamin® for 90 days to assess its effectiveness in reducing halitosis

12 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Treatment Details

Interventions

• Aquamin

Trial Overview The trial tests if Aquamin®, a natural multi-mineral supplement from red marine algae, reduces halitosis over 90 days. Participants will take Aquamin® and adhere to specific oral hygiene practices throughout the study.

Participant Groups

Group I: Aquamin® Experimental Treatment 1 Intervention

Aquamin is already approved in European Union, United States for the following indications:

Approved in European Union as Aquamin for:

• Digestive health support
• Bone health support

Approved in United States as Aquamin for:

• Dietary supplement for digestive health
• Bone health support

Who Is Running the Clinical Trial?

University of Michigan

Lead Sponsor

Trials

1,891

Recruited

6,458,000+

Findings from Research

In a study of 20 dental offices, 70% of dental unit waterlines were contaminated with high levels of aerobic mesophilic heterotrophic bacteria, which poses a risk to patients and dental staff, especially those with weakened immune systems.

The study found that 90% of dental offices had medium levels of bacterial air contamination, while all offices had low levels of microfungal air contamination, indicating a potential link between water quality and indoor air quality in dental settings.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microbial contamination of dental unit waterlines and effect on quality of indoor air. Kadaifciler, DG., Cotuk, A.[2022]

A study of water samples from 20 dental offices revealed that only 3.4% of samples met the American Dental Association's standard for water quality, indicating significant microbial contamination in dental unit waterlines.

Out of 59 samples tested, 24% were positive for Pseudomonas species and 30.5% for fungi, highlighting a potential risk for immunocompromised patients due to the presence of opportunistic pathogens.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Microbial contamination of dental unit waterlines in Istanbul, Turkey. Göksay, D., Cotuk, A., Zeybek, Z.[2021]

Dental-unit-water-lines (DUWLs) can develop harmful biofilms that contaminate water used in dental treatments, posing infection risks to both patients and dental staff from pathogens like Legionella and Pseudomonas.

Current testing methods for microbial contamination in DUWLs, such as culture on R2A agar plates, are costly and impractical for routine use, highlighting the need for more effective in-office monitoring systems that can reliably ensure compliance with UK guidelines for water safety.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Monitoring dental-unit-water-line output water by current in-office test kits. Lal, S., Singhrao, SK., Bricknell, M., et al.[2021]

Out of 100 water samples from dental unit waterlines, 37 exceeded the safe limit of 200 colony-forming units (CFU)/mL, indicating significant bacterial contamination that could pose health risks to patients and dental staff.

Pseudomonas aeruginosa was isolated from three dental unit waterlines, but no Legionella or Staphylococcus aureus were found; the study also identified several effective antibiotics, including cefoperazone and ciprofloxacin, against the isolated bacteria.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Investigation of the bacterial load and antibiotic susceptibility of dental units. Güngör, ND., Kadaifçiler, DG., Peker, OÖ.[2022]

In a study analyzing 52 infectious episodes in children, Streptococcus anginosus was most commonly found in genitourinary tract infections, particularly balanoposthitis, which was present in 73% of these cases.

All strains of S. anginosus showed 100% susceptibility to key antibiotics like penicillin and ampicillin, indicating effective treatment options for infections caused by this bacterium.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Sites of infection associated with Streptococcus anginosus group among children. Furuichi, M., Horikoshi, Y.[2018]

References

1. Netherlands pubmed.ncbi.nlm.nih.gov

Microbial contamination of dental unit waterlines and effect on quality of indoor air. [2022]

2. Netherlands pubmed.ncbi.nlm.nih.gov

Microbial contamination of dental unit waterlines in Istanbul, Turkey. [2021]

3. United States pubmed.ncbi.nlm.nih.gov

Monitoring dental-unit-water-line output water by current in-office test kits. [2021]

4. Netherlands pubmed.ncbi.nlm.nih.gov

Investigation of the bacterial load and antibiotic susceptibility of dental units. [2022]

5. Netherlands pubmed.ncbi.nlm.nih.gov

Sites of infection associated with Streptococcus anginosus group among children. [2018]