Clinical Study of the Effect of Two Experimental Lozenges on Oral Malodor After Single Use

Oral Malodor Clinical Trial

Official title: A Comparative, Randomized, Evaluator-Blind, Parallel-Group Clinical Study of the Effect of Two Experimental Lozenges on Oral Malodor After Single Use

Status Completed

Clinical Trial 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.

Clinical Trial Description

n/a

Related Conditions & MeSH terms

• Oral Malodor

• NCT number: NCT05950529
• Study type: Interventional
• Source: Novozymes A/S
• Status: Completed
• Phase: N/A
• Start date: February 6, 2020
• Completion date: March 11, 2020