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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05950529
• Other study ID #: NZ-OHBF-2020-01
• Status: Completed
• Phase: N/A
• Start date: February 6, 2020
• Est. completion date: March 11, 2020

Study information

• Verified date: July 2023
• Source: Novozymes A/S
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 156
• Est. completion date: March 11, 2020
• Est. primary completion date: March 11, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Oral Malodor

Intervention

Other:
• Experimental lozenge with the enzyme Polyphenol oxidase and green coffee extract
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.
• Experimental lozenge with the enzyme Polyphenol oxidase, green coffee extract and flavor
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)
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
no product

Locations

Country	Name	City	State
United States	Salus Research	Fort Wayne	Indiana

Sponsors (1)

Lead Sponsor	Collaborator
Novozymes A/S

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Secondary	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
Secondary	Total VSC (OralChroma) readings	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
Secondary	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