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NCT05950529 · ClinicalTrials.gov registry record · NA
Clinical Study of the Effect of Two Experimental Lozenges on Oral Malodor After Single Use
A NA study of Oral Malodor, sponsored by Novozymes A/S.
- Completed
- Registry status
- NA
- Development phase
- 156
- Enrollment target
- 1
- Study location
NCT05950529 is a NA study of Oral Malodor that has completed, run by Novozymes A/S. The registered enrollment target is 156 participants. The trial reports 1 study location across 1 state.
The verdict
NCT05950529, a NA study of Oral Malodor, has completed, sponsored by Novozymes A/S.
- COMPLETED
- Registry status
- NA
- Development phase
- 156 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to compare the control of oral malodor between an investigational lozenge with the enzyme polyphenol oxidase plus green coffee extract or an investigational lozenge with color and flavor along with the enzyme polyphenol oxidase plus green coffee extract in generally healthy subjects. Safety will be evaluated also. Subjects will be randomly assigned to one of four study groups (group code: A, B, C or D): * Experimental lozenge with the enzyme Polyphenol oxidase and green coffee extract * Experimental lozenge with the enzyme Polyphenol oxidase, green coffee extract and flavor * Placebo lozenge control (sorbitol only) * No product control Subjects will be asked to allow their assigned lozenge to dissolve in the mouth while placed on the dorsal surface of the tongue. Subjects can suck on the lozenge and press the lozenge against the palate; however, the lozenge should not be moved around in the mouth or placed on the buccal mucosa. Subjects should avoid biting or chewing the lozenge and talking while dissolving the lozenge. After the lozenge has completely dissolved, the subject will be instructed to swallow the remaining solution. Immediately (no later than 5 minutes) after subjects use their assigned lozenge product or no product, subjects will receive organoleptic assessments (OI) by the 4-5 trained judges and VSC readings (OralChroma readings). Organoleptic measurements (OI) will be repeated at 30 minutes, 1, 2, 3, and 4 hours following test product use or no test product use. OralChroma measurements will be performed again after 30 minutes, 1, 2, 3, and 4 hours after test product use or no test product. Subjects will complete a post-product performance questionnaire after the 1-hour OI and OralChroma assessments have been administered. Following the 4-hour OralChroma assessment, each subject will receive a final oral soft and hard tissue exam for safety.
Conditions Studied
Interventions
- OTHER Experimental lozenge with the enzyme Polyphenol oxidase and green coffee extract
- OTHER Experimental lozenge with the enzyme Polyphenol oxidase, green coffee extract and flavor
- OTHER Placebo lozenge control (sorbitol only)
- OTHER No product
Study Locations (1)
Indiana
- Salus Research - Fort Wayne
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 156 participants |
| Start Date | 2020-02-06 |
| Est. Completion | 2020-03-11 |
| Phase | NA |
Interested in This Trial?
Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT05950529
The ClinicalTrials.gov registry entry for NCT05950529 describes a study currently listed as completed, categorized as NA. The registered enrollment target is 156 participants, a figure that helps gauge the scale of data the investigators plan to collect. The listed sponsor is Novozymes A/S, which has 5 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Oral Malodor appearing as the primary indexed condition, and to 4 interventions - of which Experimental lozenge with the enzyme Polyphenol oxidase and green coffee extract is the first listed.
NCT05950529 reports 1 study location spanning 1 distinct geographic area - top geographies include Indiana.
Frequently Asked Questions
What is clinical trial NCT05950529 about?
NCT05950529 is a clinical study titled "Clinical Study of the Effect of Two Experimental Lozenges on Oral Malodor After Single Use". The goal of this clinical trial is to compare the control of oral malodor between an investigational lozenge with the enzyme polyphenol oxidase plus green coffee extract or an investigational lozenge with color and flavor along with the enzyme polyphenol oxidase plus green coffee extract in generall...
What is the current status of trial NCT05950529?
This trial is currently completed. It is a NA study. The enrollment target is 156 participants. The study started on 2020-02-06. Estimated completion is 2020-03-11.
What conditions does trial NCT05950529 study?
This clinical trial studies the following conditions: Oral Malodor.
What interventions are being tested in trial NCT05950529?
The interventions under investigation include: Experimental lozenge with the enzyme Polyphenol oxidase and green coffee extract (OTHER), Experimental lozenge with the enzyme Polyphenol oxidase, green coffee extract and flavor (OTHER), Placebo lozenge control (sorbitol only) (OTHER), No product (OTHER).
Who is sponsoring clinical trial NCT05950529?
This trial is sponsored by Novozymes A/S, which has 5 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT05950529 being conducted?
This trial has 1 study location across Indiana. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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