Effectiveness of Aquamin® in Mitigating Halitosis
Primary Purpose
Healthy, Halitosis
Status
Recruiting
Phase
Phase 2
Locations
United States
Study Type
Interventional
Intervention
Aquamin
Sponsored by
About this trial
This is an interventional treatment trial for Healthy focused on measuring Aquamin®
Eligibility Criteria
Inclusion Criteria:
- 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
- Willing to not scrape their tongue with a toothbrush, oral hygiene aid, or other utensil during the study participation
- Periodontally stable
- Self-reported halitosis
- A negative pregnancy test for pre-menopausal women with intact female reproductive organs, and subject must agree to use appropriate birth control over the study period.
Exclusion Criteria:
- Pregnant or lactating women
- Participating in any other interventional trials using an investigational drug
- 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
- Any gastrointestinal or colonic malignancy- Kidney disease, including kidney "stones" or hypercalcemia
- Coagulopathy/hereditary hemorrhagic disorders/or receiving therapeutic doses of Coumadin or heparin
- Presence of one or more cavitated carious lesions, untreated dental abscesses (endodontic or periodontal), untreated periodontitis (gum disease), or oral pathologies that may contribute to oral malodor (e.g., candidiasis, erosive gingival conditions)
- Taking any of the following within 30 days (will be eligible after completing 30 days of wash out period):
Calcium; Vitamin D, including multivitamins that have low amounts of calcium/Vitamin D supplements; Oral steroids; Non-steroidal anti-inflammatory medications (NSAIDS); Antibiotics.
Sites / Locations
- University of Michigan School of DentistryRecruiting
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Aquamin®
Arm Description
Outcomes
Primary Outcome Measures
Halitosis Associated Life-quality Test (HALT) questionnaire (modified)
Following the intervention, participants will answer questions regarding if their bad breath has improved over the course of the study compared to the starting point. The scores will be from 0 (no issue) - 5 (worst possible issue) for each question.
Secondary Outcome Measures
Full Information
NCT ID
NCT05058638
First Posted
September 16, 2021
Last Updated
July 25, 2023
Sponsor
University of Michigan
1. Study Identification
Unique Protocol Identification Number
NCT05058638
Brief Title
Effectiveness of Aquamin® in Mitigating Halitosis
Official Title
Evaluation of Halitosis Using a Multi-Mineral Approach (Aquamin®)
Study Type
Interventional
2. Study Status
Record Verification Date
July 2023
Overall Recruitment Status
Recruiting
Study Start Date
August 15, 2022 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
August 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Michigan
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The purpose of this study is to assess whether Aquamin®, a multi-mineral natural product from red marine algae, can help reduce halitosis when taken for 90 days.
Detailed Description
This is a sub-study to the ongoing clinical trial entitled: Aquamin®, a multi-mineral natural product from red marine algae, as an adjuvant intervention for mild ulcerative colitis and ulcerative colitis in remission (HUM00156676) NCT# NCT03869905.
However, the Food and Drug Administration (FDA) indicated that no Investigational New Drug Application (IND) was required.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Healthy, Halitosis
Keywords
Aquamin®
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
Aquamin®
Arm Type
Experimental
Intervention Type
Drug
Intervention Name(s)
Aquamin
Other Intervention Name(s)
Nutritional
Intervention Description
Participants will take a 90-day supply of Aquamin®, 4 capsules per day; 2 to be taken in the morning and 2 in the evening (containing approximately 800 mg calcium/day).
Primary Outcome Measure Information:
Title
Halitosis Associated Life-quality Test (HALT) questionnaire (modified)
Description
Following the intervention, participants will answer questions regarding if their bad breath has improved over the course of the study compared to the starting point. The scores will be from 0 (no issue) - 5 (worst possible issue) for each question.
Time Frame
90 days (post-intervention)
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
99 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
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
Willing to not scrape their tongue with a toothbrush, oral hygiene aid, or other utensil during the study participation
Periodontally stable
Self-reported halitosis
A negative pregnancy test for pre-menopausal women with intact female reproductive organs, and subject must agree to use appropriate birth control over the study period.
Exclusion Criteria:
Pregnant or lactating women
Participating in any other interventional trials using an investigational drug
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
Any gastrointestinal or colonic malignancy- Kidney disease, including kidney "stones" or hypercalcemia
Coagulopathy/hereditary hemorrhagic disorders/or receiving therapeutic doses of Coumadin or heparin
Presence of one or more cavitated carious lesions, untreated dental abscesses (endodontic or periodontal), untreated periodontitis (gum disease), or oral pathologies that may contribute to oral malodor (e.g., candidiasis, erosive gingival conditions)
Taking any of the following within 30 days (will be eligible after completing 30 days of wash out period):
Calcium; Vitamin D, including multivitamins that have low amounts of calcium/Vitamin D supplements; Oral steroids; Non-steroidal anti-inflammatory medications (NSAIDS); Antibiotics.
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Muhammad Nadeem Aslam
Phone
734-936-1897
Email
mnaslam@umich.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
James Varani
Organizational Affiliation
University of Michigan
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Muhammad N Aslam
Organizational Affiliation
University of Michigan
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Janet Kinney
Organizational Affiliation
University of Michigan
Official's Role
Study Director
Facility Information:
Facility Name
University of Michigan School of Dentistry
City
Ann Arbor
State/Province
Michigan
ZIP/Postal Code
48109
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Alice Ou
Phone
734-763-3346
Email
aliceou@umich.edu
12. IPD Sharing Statement
Plan to Share IPD
No
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Effectiveness of Aquamin® in Mitigating Halitosis
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