CompletedNot Applicable

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

United States156 participantsStarted 2020-02-06

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Generally healthy males and females ≥ 18 years of age.
✓. Able to read, sign and receive a copy of the signed informed consent form.
✓. Organoleptic score (Odor Intensity) ≥ 2 (morning breath: at least 6-12 hours following oral hygiene, eating or drinking) at Screening Visit, based on the average ratings of at least 4 Odor Intensity judges.
✓. Have an OralChroma reading ≥ 125 ppb hydrogen sulfide H2S gas, vsc (at least 6-12 hours after eating or drinking or oral hygiene).
✓. Intra-oral cause of bad breath (non-systemic origin) as determined by health history or exam.
✓. Have at least 16 natural teeth.
✓. Agree to abstain from eating, drinking, chewing gum, and any oral hygiene at least 6-12 hours prior to evaluation of oral malodor (Screening and Baseline visits).
✓. Agree to avoid drinking alcohol beverages and eating spicy foods, garlic and onions, cabbage, spices, cauliflower and radishes (sulfur compounds) 48 hours prior to each study visit.

Exclusion criteria

What they're measuring

Total VSC (OralChroma) readings

Timeframe: 5 minutes

Trial details

NCT IDNCT05950529

SponsorNovozymes A/S

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2020-03-11

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