At a glance
ClinicalIndex Comparison RecordN/ACompleted· 56 enrolled
Drug / intervention
Biotene mouthwash +1 moreother
Likely dose
Biotene mouthwash 15 mL rinse swishing for 30 seconds, single useAI-extracted
Key inclusion· 4
- ✓Age 18-84 years inclusive
- ✓Reports dry mouth symptoms meeting DMSQ criteria (≥2 of 4 questions answered as 'agree a little', 'agree' or 'strongly agree')
- ✓Unstimulated whole salivary flow rate ≤0.1 ml/min at screening
- ✓Good general and mental health with no clinically significant abnormalities
Key exclusion· 9
- ✕Pregnant, breastfeeding, or positive pregnancy test
- ✕Currently undergoing radiotherapy and/or chemotherapy treatment
- ✕Untreated oral mucosal disease that could interfere with study (e.g. current oral ulceration)
- ✕Complete denture wearer
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Clinical Study Evaluating the Consumer Perception of an Experimental Mouthwash Formulation After a Single Use
In Brief
A clinical study evaluating Biotene mouthwash and Bottled mineral water for Xerostomia. Completed, enrolled 56 participants across 1 site.
Detailed Summary
The purpose of this study is to investigate the consumer perception of an experimental mouthwash formulation in population with dry mouth
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsXerostomia
CountriesUnited States
Collaborators--
Timeline
N/ACompletedFinished
2017201820192020202120222023202420252026
Enrollment StartAug 2016
Primary CompletionOct 2016
First PostedDec 2016
TodayJul 2026
First PostedDec 29, 2016
Enrollment StartAug 31, 2016
Primary CompletionOct 19, 2016
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 9.5 years ago
Interventions
Biotene mouthwashother
Participants will rinse their mouth with 15 mL of Biotene mouthwash swishing for 30 seconds.
Bottled mineral waterother
Participants will rinse their mouth with 15 mL of the water swishing for 30 seconds.