Consumer Perception of an Experimental Mouthwash After a Single Use in Dry Mouth Subjects
Status: | Completed |
---|---|
Conditions: | Other Indications |
Therapuetic Areas: | Other |
Healthy: | No |
Age Range: | 18 - 84 |
Updated: | 7/21/2018 |
Start Date: | August 31, 2016 |
End Date: | October 19, 2016 |
A Clinical Study Evaluating the Consumer Perception of an Experimental Mouthwash Formulation After a Single Use
The purpose of this study is to investigate the consumer perception of an experimental
mouthwash formulation in population with dry mouth
mouthwash formulation in population with dry mouth
Inclusion Criteria:
- Demonstrates understanding of the study procedures, restrictions and willingness to
participate as evidenced by voluntary written informed consent and has received a
signed and dated copy of the informed consent form
- Aged 18 - 84 years inclusive
- Good general and mental health with, in the opinion of the investigator or medically
qualified designee no clinically significant and relevant abnormalities in medical
history or upon oral examination
- Participant reports having a feeling of a dry mouth according to the Dry Mouth
Screening Questionnaire (DMSQ) (Subject must answer at least 2 out of the 4 questions
with 'agree a little', 'agree' or 'strongly agree' at the Screening Visit (Visit 1).
Participants with un-stimulated whole salivary flow rate of ≤0.1 ml/min at the
Screening Visit (Visit 1).
- Participants with un-stimulated whole salivary flow rate of ≤0.1 ml/min ATH the
Screening Visit (Visit 1).
- Understands and is willing, able and likely to comply with all study procedures and
restrictions
Exclusion Criteria:
- Women who are known to be pregnant or who are intending to become pregnant over the
duration of the study or have a positive urine pregnancy test at the Screening Visit
- Women who are breast-feeding
- Participant is currently undergoing radiotherapy and/or chemotherapy treatment
- Any condition the investigator identifies that can confound the participant's ability
to properly participate in the study e.g. Alzheimer's Disease
- Participant with untreated oral mucosal disease which in the opinion of the
investigator could interfere with the study (e.g. current oral ulceration)
- Evidence of gross intra-oral neglect or need for extensive dental therapy
- Denture wearer (complete dentures)
- Participant not on stable doses of prescription systemic parasympathetic medications
(e.g. Pilocarpine), for the treatment of the feeling of dry mouth
- Known or suspected intolerance or hypersensitivity to the study materials (or closely
related compounds) or any of their stated ingredients
- Participation in another clinical study (including cosmetic studies) or receipt of an
investigational drug within 14 days of the screening visit
- Previous participation in this study
- Recent history (within the last 1 year) of alcohol or other substance abuse
- An employee of the sponsor or the clinical study team or members of their immediate
family. Students and employees of the Tufts University School of Dental Medicine not
associated with the clinical trials team are eligible to participate. Students and
employees will not be specifically targeted for enrollment
- Non-English speaking Participants will not be enrolled in the study. Participants must
be able to read and write in English
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