Xerostomia
Conditions
Brief summary
The purpose of this study is to investigate the consumer perception of an experimental mouthwash formulation in population with dry mouth
Interventions
OTHERBiotene mouthwash
Participants will rinse their mouth with 15 mL of Biotene mouthwash swishing for 30 seconds.
OTHERBottled mineral water
Participants will rinse their mouth with 15 mL of the water swishing for 30 seconds.
Sponsors
GlaxoSmithKline
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
OTHER
Masking
SINGLE (Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to 84 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1 | Within 2 minutes post product use | Participants answered the following question, Q1: how much do you agree or disagree with the following statements about this product, having used it? This product is gentle: disagree strongly, disagree, neither agree nor disagree, agree, or agree strongly. There was no formal statistical hypothesis to be tested for this outcome.. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Within 2 minutes post product use | Participants answered the following questions, Q3: Which of following statements best describes how much you liked product overall? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 4: Which of the following statements best describes how much you liked overall flavor of rinse? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 5: How you would rate flavor intensity of oral rinse? strongest flavor imaginable, very strong, strong, moderate, weak, barely detectable, no flavor at all. Q 6: Did you experience any of following sensations in your mouth & how strong was sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Participants who selected None for a particular sensation, did not complete Q 7 for that sensation: When did you experience sensations in your mouth? initially, during use, or after use. |
| Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Within 30 ± 5 minutes post product use | Participants answered the following question; Q1: Are you experiencing any of the following sensations in your mouth and how strong is the sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Q2: Would you continue use of the product? (Yes or No) |
| Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Within 5 minutes post product use | Participants rated the following criteria on a scale of 1 to 5(1=Poor, 2= Fair, 3= Good, 4= Very good, 5= Excellent) as follows: 1. Having an immediate dry mouth relief, 2. Having an immediate lubricating effect, 3. Having an immediate moisturizing effect. |
Countries
United States
Participant flow
Recruitment details
Participants were recruited at a single center in United states of America (U.S.A)
Pre-assignment details
A total 58 participants were screened, out of which 56 participants were enrolled in the study. Two participants were not enrolled as they did not meet the study criteria. Of 56 enrolled participants, 55 participants were randomized as one participant withdrew consent.
Participants by arm
| Arm | Count |
|---|---|
| Overall Study Participants All randomized participants who received both the treatments experimental oral rinse/mouthwash and mineral water were included in the baseline assessment. | 55 |
| Total | 55 |
Baseline characteristics
| Characteristic | Overall Study Participants |
|---|---|
| Age, Continuous | 54.2 years STANDARD_DEVIATION 14.53 |
| Race/Ethnicity, Customized Hispanic or Latino | 7 Participants |
| Race/Ethnicity, Customized Not Hispanic or Latino | 48 Participants |
| Sex: Female, Male Female | 15 Participants |
| Sex: Female, Male Male | 40 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | 0 / 55 | 0 / 55 |
| other Total, other adverse events | 1 / 55 | 0 / 55 |
| serious Total, serious adverse events | 0 / 55 | 0 / 55 |
Outcome results
Primary
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1
Participants answered the following question, Q1: how much do you agree or disagree with the following statements about this product, having used it? This product is gentle: disagree strongly, disagree, neither agree nor disagree, agree, or agree strongly. There was no formal statistical hypothesis to be tested for this outcome..
Time frame: Within 2 minutes post product use
Population: Analysis for this outcome was performed on intent to treat (ITT) population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment.
| Arm | Measure | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1 | Disagree Strongly | 1 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1 | Disagree | 5 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1 | Agree Strongly | 17 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1 | Neither Agree nor Disagree | 6 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1 | Agree | 26 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1 | Agree | 21 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1 | Disagree Strongly | 1 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1 | Neither Agree nor Disagree | 5 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1 | Disagree | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No.1 | Agree Strongly | 28 Participants |
Secondary
Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7
Participants answered the following questions, Q3: Which of following statements best describes how much you liked product overall? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 4: Which of the following statements best describes how much you liked overall flavor of rinse? liked it-extremely, very much, somewhat, slightly, did not like it that much, did not like it at all. Q 5: How you would rate flavor intensity of oral rinse? strongest flavor imaginable, very strong, strong, moderate, weak, barely detectable, no flavor at all. Q 6: Did you experience any of following sensations in your mouth & how strong was sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Participants who selected None for a particular sensation, did not complete Q 7 for that sensation: When did you experience sensations in your mouth? initially, during use, or after use.
Time frame: Within 2 minutes post product use
Population: ITT population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment. Note: Number of participants who answered question 6 proceeded to answer question 7. Participants also chosen more than one answer for question 7.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Soothing): None | 3 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Numbing): Moderate | 2 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Refreshing): None | 3 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Numbing): Severe | 0 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q5: Moderate | 27 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Numbing): Missing | 1 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Refreshing): Mild | 7 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Numbing): Initially-first contact with mouth | 3 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q5: Barely detectable | 0 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Numbing):During use - whilst swishing in mouth | 2 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Refreshing): Moderate | 27 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Numbing):After use - after spitting out product | 4 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q5: Weak | 0 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Burning): None | 45 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Refreshing): Severe | 18 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Burning): Mild | 5 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Soothing): Mild | 11 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Burning): Moderate | 2 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Refreshing): Missing | 0 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Burning): Severe | 2 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Moisturizing): Moderate | 30 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Burning): Missing | 1 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Refreshing): Initially-first contact with mouth | 30 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Burning): Initially-first contact with mouth | 2 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Soothing): Moderate | 28 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Burning):During use - whilst swishing in mouth | 4 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Refreshing):During use-whilst swishing in mouth | 32 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Burning):After use - after spitting out product | 3 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Moisturizing): None | 3 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Drying Out): None | 49 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Refreshing)After use-after spitting out product | 32 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Drying Out): Mild | 4 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Soothing): Severe | 13 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Drying Out): Moderate | 1 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Tingling): None | 24 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Drying Out): Severe | 0 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Moisturizing): Severe | 10 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Drying Out): Missing | 1 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Soothing): Initially - first contact with mouth | 23 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Drying Out): Initially-first contact with mouth | 1 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Tingling): Mild | 13 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Drying Out):During use-whilst swishing in mouth | 1 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Moisturizing)Initially-first contact with mouth | 30 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Drying Out)After use-after spitting out product | 5 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Tingling): Moderate | 14 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q3: Liked it extremely | 13 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q3: Liked it very much | 27 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Soothing): During use -whilst swishing in mouth | 34 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Tingling): Severe | 3 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q3: Liked it slightly | 6 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Tingling): Missing | 1 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q3: Did not like it that much | 4 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q5: No flavor at all | 0 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q3: Did not Like it at all | 1 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Tingling): Initially-first contact with mouth | 10 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7Moisturizing:During use-whilst swishing in mouth | 30 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q4: Liked it somewhat | 8 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q4: Did not Like it at all | 2 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Tingling):During use - whilst swishing in mouth | 17 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q5: Strongest flavor imaginable | 5 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Moisturizing): Mild | 12 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q5: Very strong | 4 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Tingling):After use -after spitting out product | 12 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7Moisturizing:After use-spitting out product | 34 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q3: Liked it somewhat | 4 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Numbing): None | 44 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q4: Liked it extremely | 16 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q4: Liked it very much | 18 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Soothing):After use-after spitting out product | 28 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q4: Liked it slightly | 8 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Numbing): Mild | 8 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q4: Did not like it that much | 3 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q5: Strong | 19 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q4: Did not like it that much | 11 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q5: Strong | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q5: Moderate | 6 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q5: Weak | 4 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q5: Barely detectable | 11 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q5: No flavor at all | 33 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Moisturizing): None | 12 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Moisturizing): Mild | 21 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Moisturizing): Moderate | 20 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Moisturizing)Initially-first contact with mouth | 30 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7Moisturizing:After use-spitting out product | 17 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Soothing): None | 15 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Soothing): Mild | 18 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Soothing): Moderate | 19 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Soothing): Severe | 3 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Soothing): Initially - first contact with mouth | 22 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Moisturizing): Severe | 2 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Soothing): During use -whilst swishing in mouth | 30 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7Moisturizing:During use-whilst swishing in mouth | 27 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Soothing):After use-after spitting out product | 11 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Refreshing): None | 15 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Refreshing): Mild | 19 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Refreshing): Moderate | 19 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Refreshing): Severe | 1 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Refreshing): Missing | 1 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Refreshing): Initially-first contact with mouth | 20 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Refreshing):During use-whilst swishing in mouth | 22 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Refreshing)After use-after spitting out product | 13 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Tingling): None | 48 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Tingling): Severe | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Tingling): Mild | 4 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Tingling): Moderate | 1 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Tingling): Missing | 2 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Tingling): Initially-first contact with mouth | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Tingling):During use - whilst swishing in mouth | 4 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Tingling):After use -after spitting out product | 1 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Numbing): None | 52 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Numbing): Mild | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Numbing): Moderate | 1 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Numbing): Severe | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Numbing): Missing | 2 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Numbing): Initially-first contact with mouth | 1 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Numbing):During use - whilst swishing in mouth | 1 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Numbing):After use - after spitting out product | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Burning): None | 53 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Burning): Mild | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Burning): Moderate | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Burning): Severe | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Burning): Missing | 2 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Burning): Initially-first contact with mouth | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Burning):During use - whilst swishing in mouth | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Burning):After use - after spitting out product | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Drying Out): None | 47 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Drying Out): Mild | 3 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Drying Out): Moderate | 1 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Drying Out): Severe | 2 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q6(Drying Out): Missing | 2 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Drying Out): Initially-first contact with mouth | 2 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Drying Out):During use-whilst swishing in mouth | 1 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q7(Drying Out)After use-after spitting out product | 4 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q3: Liked it very much | 15 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q3: Liked it somewhat | 13 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q3: Liked it slightly | 9 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q3: Did not like it that much | 7 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q4: Liked it extremely | 9 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q4: Liked it very much | 9 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q4: Did not Like it at all | 5 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q5: Strongest flavor imaginable | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q5: Very strong | 1 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q3: Liked it extremely | 7 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q3: Did not Like it at all | 4 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q4: Liked it somewhat | 14 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 1 (PPUQ 1); Question No. 3-7 | Q4: Liked it slightly | 7 Participants |
Secondary
Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2)
Participants answered the following question; Q1: Are you experiencing any of the following sensations in your mouth and how strong is the sensation? moisturizing, soothing, refreshing, tingling, numbing, burning, or drying out. Q2: Would you continue use of the product? (Yes or No)
Time frame: Within 30 ± 5 minutes post product use
Population: Analysis for this outcome was performed on ITT population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment.
| Arm | Measure | Group | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Soothing: Missing | 0 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Drying Out: Moderate | 1 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Tingling: Missing | 0 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Numbing: None | 52 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Numbing: Mild | 2 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Numbing: Moderate | 1 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Numbing: Severe | 0 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Numbing: Missing | 0 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Burning: None | 53 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Burning: Mild | 1 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Burning: Moderate | 0 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Burning: Severe | 0 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Burning: Missing | 1 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Drying Out: None | 45 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Drying Out: Mild | 6 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Drying Out: Severe | 2 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Drying Out: Missing | 1 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q2: Would You Continue Use of The Product? Yes | 43 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q2: Would You Continue Use of The Product? No | 12 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Moisturizing: None | 7 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Moisturizing: Mild | 20 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Moisturizing: Moderate | 23 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Moisturizing: Severe | 5 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Soothing: None | 9 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Soothing: Mild | 20 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Soothing: Moderate | 24 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Soothing: Severe | 2 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Refreshing: None | 10 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Refreshing: Mild | 24 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Refreshing: Moderate | 17 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Refreshing: Severe | 4 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Refreshing: Missing | 0 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Tingling: None | 46 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Tingling: Mild | 7 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Tingling: Moderate | 2 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Tingling: Severe | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q2: Would You Continue Use of The Product? No | 35 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Tingling: Moderate | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Drying Out: Moderate | 5 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Tingling: Severe | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Moisturizing: None | 27 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Tingling: Missing | 3 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Refreshing: None | 38 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Numbing: None | 50 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Moisturizing: Mild | 22 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Numbing: Mild | 2 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Refreshing: Missing | 3 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Numbing: Moderate | 1 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Moisturizing: Moderate | 5 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Refreshing: Mild | 7 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Numbing: Missing | 2 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Moisturizing: Severe | 1 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Burning: None | 51 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Tingling: Mild | 1 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Burning: Mild | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Soothing: None | 35 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Burning: Moderate | 1 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Refreshing: Moderate | 6 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Burning: Severe | 1 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Soothing: Mild | 14 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Burning: Missing | 2 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Tingling: None | 51 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Drying Out: None | 36 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Soothing: Moderate | 3 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Drying Out: Mild | 5 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Refreshing: Severe | 1 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Drying Out: Severe | 7 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Soothing: Severe | 1 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Drying Out: Missing | 2 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Numbing: Severe | 0 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q2: Would You Continue Use of The Product? Yes | 20 Participants |
| Mineral Water | Number of Participants With Response to Post-Product Use Questionnaires 2 (PPUQ 2) | Q1: Soothing: Missing | 2 Participants |
Secondary
Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ)
Participants rated the following criteria on a scale of 1 to 5(1=Poor, 2= Fair, 3= Good, 4= Very good, 5= Excellent) as follows: 1. Having an immediate dry mouth relief, 2. Having an immediate lubricating effect, 3. Having an immediate moisturizing effect.
Time frame: Within 5 minutes post product use
Population: Analysis for this outcome was performed on ITT population which included all the participants who were randomized, received at least one dose of treatment during the study and had at least one post-baseline assessment.
| Arm | Measure | Group | Category | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|---|---|
| Experimental Oral Rinse | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q1 | Poor | 3 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q2 | Fair | 11 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q1 | Very good | 22 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q2 | Poor | 2 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q2 | Excellent | 13 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q3 | Excellent | 13 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q1 | Fair | 9 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q3 | Very good | 21 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q2 | Very good | 19 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q3 | Good | 9 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q1 | Good | 7 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q3 | Fair | 11 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q2 | Good | 10 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q3 | Poor | 1 Participants |
| Experimental Oral Rinse | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q1 | Excellent | 14 Participants |
| Mineral Water | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q3 | Poor | 14 Participants |
| Mineral Water | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q1 | Excellent | 4 Participants |
| Mineral Water | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q1 | Very good | 9 Participants |
| Mineral Water | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q1 | Good | 19 Participants |
| Mineral Water | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q1 | Fair | 13 Participants |
| Mineral Water | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q1 | Poor | 10 Participants |
| Mineral Water | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q2 | Excellent | 2 Participants |
| Mineral Water | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q2 | Very good | 9 Participants |
| Mineral Water | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q2 | Good | 13 Participants |
| Mineral Water | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q2 | Fair | 16 Participants |
| Mineral Water | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q2 | Poor | 15 Participants |
| Mineral Water | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q3 | Excellent | 3 Participants |
| Mineral Water | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q3 | Very good | 7 Participants |
| Mineral Water | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q3 | Good | 18 Participants |
| Mineral Water | Number of Participants With Response to Product Performance Attribute Questionnaire (PPAQ) | Q3 | Fair | 13 Participants |