Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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):
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.
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A | Experimental | Experimental lozenge with the enzyme Polyphenol oxidase plus green coffee extract |
|
| Group B | Experimental | Experimental lozenge with the enzyme Polyphenol oxidase, green coffee extract and flavor |
|
| Group C | Placebo Comparator | Placebo lozenge Control (sorbitol only) |
|
| Group D | Other | No Product Control |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Experimental lozenge with the enzyme Polyphenol oxidase and green coffee extract | Other | Subjects will be instructed 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 dissolved, the subject will be instructed to swallow the remaining solution. |
| Measure | Description | Time Frame |
|---|---|---|
| Total VSC (OralChroma) readings | The mean total VSC (OralChroma) readings from the Baseline assessment to the immediate (5 minutes) assessment following product use. | 5 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| OI scores | OI scores from the Baseline assessment (derived from mean odor ratings of the 4 judges) to immediate (5 minutes), 30 minutes, 1, 2, 3, and 4 hours following product use. | 5 minutes, 30 minutes, 1, 2, 3, and 4 hours |
| Total VSC (OralChroma) readings |
Not provided
Inclusion Criteria:
To be eligible for study participation, subjects must meet the following criteria:
Exclusion Criteria:
Subjects presenting with any of the following will not be included in the study:
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jeffrey Milleman, DDS, MPA | Salus Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Salus Research | Fort Wayne | Indiana | 46825 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 39496199 | Derived | Santos SL, Holz C, Milleman K, Milleman J, Wenqian G, Mateo LR. Effectiveness of a combination of laccase and green coffee extract on oral malodor: a comparative, randomized, controlled, evaluator-blind, parallel-group trial. J Breath Res. 2024 Nov 25;19(1). doi: 10.1088/1752-7163/ad8e7c. |
Not provided
Not provided
Individual participant data will be kept confidential at the study center will not be shared externally.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Oral Malodor examiners are blinded and the subjects do not know which of the 2 lozenges they are taking
|
| Experimental lozenge with the enzyme Polyphenol oxidase, green coffee extract and flavor | Other | Subjects will be instructed 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 dissolved, the subject will be instructed to swallow the remaining solution. |
|
| Placebo lozenge control (sorbitol only) | Other | Subjects will be instructed 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 dissolved, the subject will be instructed to swallow the remaining solution. |
|
| No product | Other | no product |
|
Mean total VSC (OralChroma) readings from the Baseline assessment to assessments 30 minutes, 1, 2, 3, and 4 hours following product use. |
| 30 minutes, 1, 2, 3, and 4 hours |
| Three major components of VSCs in mouth air | Mean levels of each of the three major components of VSCs in mouth air: hydrogen sulfide (H2S), methyl mercaptan (CH3SH), and dimethyl sulfide ([CH3]2S) gases from the Baseline assessment to immediate (5 minutes), 1, 2, 3, and 4 hours following product use. | 5 minutes, 30 minutes, 1, 2, 3, and 4 hours |
| ID | Term |
|---|---|
| D005421 | Flavoring Agents |
| ID | Term |
|---|---|
| D010592 | Pharmaceutic Aids |
| D004364 | Pharmaceutical Preparations |
| D005503 | Food Additives |
| D000074385 | Food Ingredients |
| D020313 | Specialty Uses of Chemicals |
| D020164 | Chemical Actions and Uses |
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
Not provided
Not provided