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Effectiveness of Aquamin® in Mitigating Halitosis

StatusRecruiting
PhasePhase 2
Started2022-08-15
View on ClinicalTrials.gov ↗
Trial flagged as At Risk
Primary completion moved at least 11 months later Dec 2026 → Dec 2027
See other at-risk trials from University of Michigan

Amendment history

2026-08-25
Study Status, Study Design, Eligibility, Contacts/Locations v12
Enrollment reopened
Enrollment increased: 15 → 25 participants
Primary completion pushed: 2026-12 → 2027-12
Completion pushed: 2026-12 → 2027-12
Eligibility criteria-163 characters
[...] smoking or using mouth rinse 60 minutes before study visits WillingHave to not scrape their tongue with a toothbrush,stable oral hygiene aid, or other utensil during the study participationhealth Periodontally stable Self-reported halitosis A negative pregnancy test for pre-menopausal women with intact female reproductive organs, and the subject must agree to use appropriate birth control over the [...] estinal bleeding from gastric or duodenal ulcers, or gastrin-secreting tumors) or active gastric/duodenal ulcers - peptic [...] r Crohn's disease Any gastrointestinal or colonic malignancy-; Kidneykidney dis [...] [...]
Study sitesdetails revised at 1 of 1 site
2026-01-15
Study Status, Sponsor/Collaborators, Contacts/Locations v11
Re-verified, no change to tracked fields
2025-07-15
Study Status v10
Primary completion date2026-06→2026-12
2025-04-25
Recruiting→Active, Not Recruiting Study Status, Study Design, Contacts/Locations v9
Trial statusRecruiting→Active, Not Recruiting
Primary completion date2025-07→2026-06
Completion date2025-10→2026-12
Enrollment target10→15
Study sitesdetails revised at 1 of 1 site
2024-05-03
Study Status v8
Primary completion date2024-06→2025-07
Completion date2024-08→2025-10
Show 7 earlier versions
2023-07-25
Study Status v7
Primary completion date2023-10→2024-06
Completion date2024-09→2024-08
2022-08-19
Study Status v6
Start dateestimated 2022-09→confirmed 2022-08-15
2022-07-28
Study Status v5
Completion date2024-06→2024-09
Start date2022-07→2022-09
2022-05-31
Study Status v4
Primary completion date2023-09→2023-10
Completion date2024-03→2024-06
Start date2022-05→2022-07
2022-03-31
Study Status, Eligibility v3
Primary completion date2023-06→2023-09
Completion date2023-12→2024-03
Start date2022-03→2022-05
Eligibility criteria+198 characters
[...] nt Willing to follow study procedures of no eating, drinking, toothbrushing, smoking or using mouth rinse 60 minutes before study visit [...] ill 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.
2021-12-16
Study Status v2
Primary completion date2023-05→2023-06
Start date2021-12→2022-03
2021-10-25
Study Status v1
Primary completion date2023-04→2023-05
Start date2021-10→2021-12
2021-09-16
Original filing
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.
Trial Details
NCT Number NCT05058638
Lead Sponsor University of Michigan
Conditions Healthy, Halitosis
Enrollment 25 participants
Start Date 2022-08-15
Primary Completion 2027-12 (estimated)
Study Completion 2027-12 (estimated)
Updated on ClinicalTrials.gov 2026-08-28