Clinical trial NCT05950529: Clinical Study of the Effect of Two Experimental Lozenges on Oral Malodor After Single Use
Official title: A Comparative, Randomized, Evaluator-Blind, Parallel-Group Clinical Study of the Effect of Two Experimental Lozenges on Oral Malodor After Single Use
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Oral Malodor
Keywords: enzymes, oral malodor
Lead sponsor: Novozymes A/S
Sponsor class: INDUSTRY
First posted: 2023-07-18
Enrollment: 156
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: SUPPORTIVE_CARE

Brief 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.


Eligibility criteria: Inclusion Criteria:

To be eligible for study participation, subjects must meet the following criteria:

1. Generally healthy males and females ≥ 18 years of age.
2. Able to read, sign and receive a copy of the signed informed consent form.
3. 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.
4. Have an OralChroma reading ≥ 125 ppb hydrogen sulfide H2S gas, vsc (at least 6-12 hours after eating or drinking or oral hygiene).
5. Intra-oral cause of bad breath (non-systemic origin) as determined by health history or exam.
6. Have at least 16 natural teeth.
7. 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).
8. 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.
9. Agree to refrain from tongue brushing/cleaning for the duration of the study.
10. Adequate oral hygiene and no signs of oral neglect.
11. Has not taken any type of probiotic supplement intended for oral health within 14 days of screening visit.

Exclusion Criteria:

Subjects presenting with any of the following will not be included in the study:

1. History of allergy or significant adverse effects following use of oral hygiene products such as toothpastes, mouth rinses, breath mints, lozenges, or chewing gum or their ingredients.
2. History of allergies to ingredients in the test product.
3. History of common food allergies (e.g. peanuts, tree nuts, milk, eggs, shellfish, fish, wheat, soybeans)
4. Self-reported as pregnant or nursing.
5. Self-reported serious medical conditions.
6. Based on history and clinical exam: advanced periodontitis, frank caries, and mucosal diseases.
7. Antibiotic or anti-inflammatory medication within 30 days of screening visit.
8. Dental prophylaxis or use of chemotherapeutic antiplaque/antigingivitis oral care products or tooth bleaching within 7 days of screening visit.
9. Smoker and/or user of smokeless tobacco products.
10. Orthodontic appliances, peri/oral piercings, or removable partial dentures.
11. Significant oral soft tissue pathology based on a visual examination.
12. Acute sinusitis or severe oral-pharyngeal infections.
13. Currently taking medications which can cause oral malodor.
14. Reduced salivary flow due to pathological reasons (e.g. Sjögrens syndrome).
15. Anything that, in the opinion of the investigator, would place the subject at increased risk or preclude the subject's full compliance with or completion of the study.
16. Participation in any oral care clinical study, concurrently or within the 30 days of screening exams.

Primary outcomes:
measure: Total VSC (OralChroma) readings
timeFrame: 5 minutes
Secondary outcomes:
measure: OI scores
timeFrame: 5 minutes, 30 minutes, 1, 2, 3, and 4 hours
measure: Total VSC (OralChroma) readings
timeFrame: 30 minutes, 1, 2, 3, and 4 hours
measure: Three major components of VSCs in mouth air
timeFrame: 5 minutes, 30 minutes, 1, 2, 3, and 4 hours
Other outcomes:
Locations:
city: Fort Wayne
country: United States
facility: Salus Research
state: Indiana
Study officials:
affiliation: Salus Research
name: Jeffrey Milleman, DDS, MPA
role: PRINCIPAL_INVESTIGATOR
References: