Halitosis Oral Health Halitosis
Conditions
Interventions
Trial product: Mouthwash containing SBO-635
Placebo: Sensorially similar mouthwash without SBO-635
Duration: 6 weeks
Administration: Subjects will be
Sponsors
Innovation Labo Research
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Non-smoking healthy subjects between 21 to 55 years (inclusive) of age 2. Subjects with conformed halitosis (Organoleptic score =2 and Halimeter score =180) 3. Subjects who are free from any active oral infections or inflammatory conditions such as dental caries, mouth ulcers, gingivitis or periodontitis 4. Subjects willing to give written informed consent and willing to comply with the trial protocol 5. Subjects willing to adhere to a standard oral care protocol during the study period 6. Subjects willing to refrain from using alcohol during the study period 7. Subjects who are able to understand the risks/benefits of the protocol 8. Subject should be available for the duration of the study period (6 weeks)
Exclusion criteria
Exclusion criteria: 1. Subjects with a history of oral malignancy 2. Subjects with possible extra oral causes for halitosis: laryngopharyngeal reflux, tonsillitis, sinusitis, metabolic acidosis or alkalosis, renal diseases, liver malfunctions, dental brackets or bridges, dental infections and diabetes mellitus 3. Pregnant or lactating females 4. Subjects who have used oral antibiotics, non-steroid anti-inflammatory drugs (NSAIDs) corticosteroids or nutrition supplements within 3 months from the start of the study 5. Subjects who are participating or have participated in any other clinical trial within 3 months from the start of the study 6. Subjects with a history of psychiatric disorder that may impair the ability of subjects to provide written informed consent 7. Drug or alcohol abusers 8. Any other condition that the Principal Investigator thinks may jeopardize the study outcome
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Halitosis measured using a Halimeter (Interscan corp., Chatsworth, CA) at baseline (day 0), day 14 and day 42 | — |
Secondary
| Measure | Time frame |
|---|---|
| Oral microbiome diversity measured using 16S rRNA gene sequencing of the V3/V4 (v3-v7) hypervariable region at baseline, day 14 and day 42 | — |
Countries
Japan
Outcome results
None listed