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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
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days (post-intervention)
Awards & highlights
Study Summary
This trial will test whether Aquamin, a natural product made from red marine algae, can help reduce halitosis (bad breath) over a 90 day period.
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.Check my eligibility
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.See study design
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 belowSelect...
I believe I have bad breath.
Select...
My gums are healthy and do not have any major issues.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days (post-intervention)
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days (post-intervention)
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Halitosis Associated Life-quality Test (HALT) questionnaire (modified)
Trial Design
1Treatment groups
Experimental Treatment
Group I: Aquamin®Experimental Treatment1 Intervention
Find a Location
Who is running the clinical trial?
University of MichiganLead Sponsor
1,796 Previous Clinical Trials
6,377,943 Total Patients Enrolled
James VaraniPrincipal InvestigatorUniversity of Michigan
2 Previous Clinical Trials
70 Total Patients Enrolled
Muhammad N AslamStudy DirectorUniversity of Michigan
2 Previous Clinical Trials
70 Total Patients Enrolled
Media Library
Eligibility Criteria:
This trial includes the following eligibility 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 believe I have bad breath.I have a bleeding disorder or am on blood thinners like Coumadin or heparin.I have untreated cavities, gum disease, or other oral conditions causing bad breath.My gums are healthy and do not have any major issues.I am not pregnant and agree to use birth control during the study.I do not have any gastrointestinal, colon cancer, kidney disease, or high calcium levels.
Research Study Groups:
This trial has the following groups:- Group 1: Aquamin®
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Bad Breath Patient Testimony for trial: Trial Name: NCT05058638 — Phase 2
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Who can sign up to help test this new medication?
"This study is looking for 10 individuals that have bad breath, are between 18-99 years old, and willing to not brush their tongue or use mouthwash 60 minutes before visits."
Answered by AI
Are there any negative side effects of taking Aquamin?
"There is some data supporting the safety of Aquamin, but none yet demonstrating its efficacy. Therefore, it received a score of 2."
Answered by AI
Are there any available positions for individuals in this clinical trial?
"Yes, the study is still looking for participants. The clinicaltrials.gov website shows that the last update to this trial was on 8/19/2022, and it was originally posted on 8/15/2022."
Answered by AI
Are people of all ages welcome in this trial?
"Eligibility for this particular clinical trial is restricted to those aged 18-99. In contrast, there are 54 studies targeting participants under the age of eighteen and 399 trials for individuals over 65 years old."
Answered by AI
Who else is applying?
How old are they?
18 - 65
What portion of applicants met pre-screening criteria?
Did not meet criteria
Met criteria
What state do they live in?
Massachusetts
Minnesota
Iowa
Other
What site did they apply to?
University of Michigan School of Dentistry
How many prior treatments have patients received?
0
What questions have other patients asked about this trial?
How long does screening visit take?
PatientReceived no prior treatments
Why did patients apply to this trial?
I hope this trial works. Extra money for college. Im suffering with bad breath past 5 -6 years and I am fed up with it and I want to improve my self confidence and brighten my life.
PatientReceived 2+ prior treatments
Suffered with halitosis the majority of my life. I would like to finally find a cure of this disorder. It has practically destroyed my life.
PatientReceived no prior treatments
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