Oral MalodorNCT05950529
Clinical Study of the Effect of Two Experimental Lozenges on Oral Malodor After Single Use
A study testing Experimental lozenge with the enzyme Polyphenol oxidase and green coffee extract, Experimental lozenge with the enzyme Polyphenol oxidase, green coffee extract and flavor and No product in people with Oral Malodor, run by Novozymes A/S at 1 site in United States.
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. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Oral Malodor
- What is being tested?
- Experimental lozenge with the enzyme Polyphenol oxidase and green coffee extract, Experimental lozenge with the enzyme Polyphenol oxidase, green coffee extract and flavor and No product
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 156 participants
- Where
- 1 siteUnited States
- Study dates
- 6 Feb 2020to 11 Mar 2020
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- To be eligible for study participation, subjects must meet the following 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.
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- 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.
- Agree to refrain from tongue brushing/cleaning for the duration of the study.
- Adequate oral hygiene and no signs of oral neglect.
- Has not taken any type of probiotic supplement intended for oral health within 14 days of screening visit.
Who cannot join
- Subjects presenting with any of the following will not be included in the study:
- 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.
- History of allergies to ingredients in the test product.
- History of common food allergies (e.g. peanuts, tree nuts, milk, eggs, shellfish, fish, wheat, soybeans)
- Self-reported as pregnant or nursing.
- Self-reported serious medical conditions.
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- Based on history and clinical exam: advanced periodontitis, frank caries, and mucosal diseases.
- Antibiotic or anti-inflammatory medication within 30 days of screening visit.
- Dental prophylaxis or use of chemotherapeutic antiplaque/antigingivitis oral care products or tooth bleaching within 7 days of screening visit.
- Smoker and/or user of smokeless tobacco products.
- Orthodontic appliances, peri/oral piercings, or removable partial dentures.
- Significant oral soft tissue pathology based on a visual examination.
- Acute sinusitis or severe oral-pharyngeal infections.
- Currently taking medications which can cause oral malodor.
- Reduced salivary flow due to pathological reasons (e.g. Sjögrens syndrome).
- 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.
- Participation in any oral care clinical study, concurrently or within the 30 days of screening exams.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Comparative, Randomized, Evaluator-Blind, Parallel-Group Clinical Study of the Effect of Two Experimental Lozenges on Oral Malodor After Single Use
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):
Read more
- 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.
- Conditions
- Oral Malodor
- Being tested
- 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
- Keywords
- enzymes, oral malodor
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Experimental lozenge with the enzyme Polyphenol oxidase and green coffee extractOther
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 flavorOther
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 productOther
no product
| Study group | Role | What they receive |
|---|---|---|
| Group A | Experimental | Experimental lozenge with the enzyme Polyphenol oxidase plus green coffee extract Receives: Other: Experimental lozenge with the enzyme Polyphenol oxidase and green coffee extract |
| Group B | Experimental | Experimental lozenge with the enzyme Polyphenol oxidase, green coffee extract and flavor Receives: Other: Experimental lozenge with the enzyme Polyphenol oxidase, green coffee extract and flavor |
| Group C | Placebo comparator | Placebo lozenge Control (sorbitol only) Receives: Other: Placebo lozenge control (sorbitol only) |
| Group D | Other | No Product Control Receives: Other: No product |
What is being measured
The primary outcome is the main question the study is designed to answer.
Total VSC (OralChroma) readings
The mean total VSC (OralChroma) readings from the Baseline assessment to the immediate (5 minutes) assessment following product use.
Measured: 5 minutes
Secondary outcomes (3)
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.
Measured: 5 minutes, 30 minutes, 1, 2, 3, and 4 hours
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.
Measured: 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.
Measured: 5 minutes, 30 minutes, 1, 2, 3, and 4 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Jul 2023
- Study start6 Feb 2020
- Primary completion11 Mar 2020
- Study completion11 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Oral MalodorStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 156 participants (actual)
Sponsor and investigators
- Lead sponsor
- Novozymes A/S
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jeffrey Milleman, DDS, MPA, Principal investigator, Salus Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05950529
- Sponsor's protocol ID
- NZ-OHBF-2020-01
- Status last verified
- Jul 2023
- First submitted
- 11 Jul 2023
- Last updated
- 18 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will be kept confidential at the study center will not be shared externally.
Publications
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.
PubMed 39496199
Study at a glance
From the registry record, last updated by the sponsor on 18 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Comparative, Randomized, Evaluator-Blind, Parallel-Group Clinical Study of the Effect of Two Experimental Lozenges on Oral Malodor After Single Use
- ClinicalTrials.gov ID
- NCT05950529
- Acronym / sponsor ID
- NZ-OHBF-2020-01
- Conditions
- Oral Malodor
- Keywords
- enzymes, oral malodor
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 156 participants (actual)
- Lead sponsor
- Novozymes A/SIndustry (pharma, biotech, devices)
- Study start
- 6 Feb 2020 (actual)
- Primary completion
- 11 Mar 2020 (actual)
- Study completion
- 11 Mar 2020 (actual)
- First posted
- 18 Jul 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| Group A | Experimental | Other: Experimental lozenge with the enzyme Polyphenol oxidase and green coffee extractExperimental lozenge with the enzyme Polyphenol oxidase plus green coffee extract |
| Group B | Experimental | Other: Experimental lozenge with the enzyme Polyphenol oxidase, green coffee extract and flavorExperimental lozenge with the enzyme Polyphenol oxidase, green coffee extract and flavor |
| Group C | Placebo comparator | Other: Placebo lozenge control (sorbitol only)Placebo lozenge Control (sorbitol only) |
| Group D | Other | Other: No productNo Product Control |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
- History of allergies to ingredients in the test product.
- History of common food allergies (e.g. peanuts, tree nuts, milk, eggs, shellfish, fish, wheat, soybeans)
- Self-reported as pregnant or nursing.
- Self-reported serious medical conditions.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Experimental lozenge with the enzyme Polyphenol oxidase and green coffee extractSubjects 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. | Other | Group A |
| Experimental lozenge with the enzyme Polyphenol oxidase, green coffee extract and flavorSubjects 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. | Other | Group B |
| 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. | Other | Group C |
| No productno product | Other | Group D |
Primary outcome
Total VSC (OralChroma) readings
Time frame: 5 minutes
The mean total VSC (OralChroma) readings from the Baseline assessment to the immediate (5 minutes) assessment following product use.
3 secondary outcomes
OI scores
Time frame: 5 minutes, 30 minutes, 1, 2, 3, and 4 hours
Total VSC (OralChroma) readings
Time frame: 30 minutes, 1, 2, 3, and 4 hours
Three major components of VSCs in mouth air
Time frame: 5 minutes, 30 minutes, 1, 2, 3, and 4 hours
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jul 2023.
- Derived from this study: PubMed 39496199Santos 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.
- Individual participant dataSharing planned: No. Individual participant data will be kept confidential at the study center will not be shared externally.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jeffrey Milleman, DDS, MPA principal investigator
Salus Research
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Experimental lozenge with the enzyme Polyphenol oxidase and green coffee extract, Experimental lozenge with the enzyme Polyphenol oxidase, green coffee extract and flavor and No product in people with Oral Malodor, run by Novozymes A/S at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 12 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 18 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Total VSC (OralChroma) readings (time frame: 5 minutes). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05950529, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Jul 2023.