What side effects are associated with this type of intervention?

Common treatments for bad breath include mouthwashes, chewing gums, and dietary supplements. Mouthwashes, especially those containing alcohol or chlorhexidine, can cause dry mouth, altered taste, and staining of teeth. Chewing gums, particularly those with artificial sweeteners like sorbitol or xylitol, may cause gastrointestinal discomfort or laxative effects if consumed in large quantities. Dietary supplements, such as multi-mineral products like Aquamin®, are generally well-tolerated but can occasionally cause gastrointestinal upset or allergic reactions in sensitive individuals. It is important to consult with a healthcare provider to determine the most appropriate treatment and to monitor for any adverse effects.

What prior FDA approvals exist?

There are no specific FDA-approved drugs solely for the treatment of bad breath (halitosis). However, various oral health products, such as mouthwashes and toothpastes containing antibacterial agents like chlorhexidine, cetylpyridinium chloride, and essential oils, are commonly used to manage halitosis. These products work by reducing oral bacteria that contribute to bad breath. While Aquamin® is being studied for its potential to reduce halitosis through multi-mineral supplementation from red marine algae, there are no directly comparable FDA-approved treatments that use a similar multi-mineral approach specifically for halitosis.

What other types of research exist?

Promising alternatives to Aquamin® for treating bad breath include probiotics, which have been shown to improve oral health by balancing the oral microbiome, and dietary interventions such as increased intake of polyunsaturated fatty acids (PUFAs) like omega-3 and omega-6, which may have anti-inflammatory properties beneficial for oral health. Additionally, folinic acid supplementation has shown potential in improving verbal communication and could indirectly benefit oral health by enhancing overall well-being.

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Multi-mineral Natural Product

Aquamin for Bad Breath

Phase 2

Recruiting

Led By James Varani

Research Sponsored by University of Michigan

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Self-reported halitosis

Periodontally stable

Must not have

Diagnosed with any stomach or intestinal bleeding disorders (gastrointestinal bleeding from gastric or duodenal ulcers, or gastrin secreting tumors) or active gastric / duodenal ulcers - peptic ulcer disease (in last 3 months) or with severe symptoms of ulcerative colitis or Crohn's disease

Coagulopathy/hereditary hemorrhagic disorders/or receiving therapeutic doses of Coumadin or heparin

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 90 days (post-intervention)

Awards & highlights

Summary

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

Who is the study for?

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.

What is being tested?

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.

What are the potential side effects?

Potential side effects of Aquamin® aren't specified in this summary but considering it's a natural mineral product, they may be minimal compared to pharmaceuticals; however, participants should report any adverse reactions.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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I believe I have bad breath.

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My gums are healthy and do not have any major issues.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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

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

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I have untreated cavities, gum disease, or other oral conditions causing bad breath.

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I do not have any gastrointestinal, colon cancer, kidney disease, or high calcium levels.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days (post-intervention)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~90 days (post-intervention)

This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days (post-intervention) for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Halitosis Associated Life-quality Test (HALT) questionnaire (modified)

Trial Design

1Treatment groups

Experimental Treatment

Group I: Aquamin®Experimental Treatment1 Intervention

0 / 6Eligibility criteria met

Research Highlights

Information in this section is not a recommendation. We encourage patients to speak with their healthcare team when evaluating any treatment decision.

Mechanism Of Action

Side Effect Profile

Prior Approvals

Other Research

Common treatments for bad breath include maintaining good oral hygiene, using antimicrobial mouthwashes, and dietary supplementation. Good oral hygiene practices, such as regular brushing and flossing, help remove food particles and plaque that harbor bacteria responsible for bad breath. Antimicrobial mouthwashes, like those containing chlorhexidine, reduce the bacterial load in the mouth, thereby decreasing the production of foul-smelling compounds. Dietary supplements, such as Aquamin® (a multi-mineral product from red marine algae), may improve oral health by providing essential minerals that strengthen teeth and gums, potentially reducing the bacterial biofilm and inflammation associated with halitosis. These treatments are crucial for bad breath patients as they address the underlying causes of halitosis, leading to improved oral health and fresher breath.