The objective of this study is to evaluate the oral soft and hard tissue tolerance after 14 days of a twice daily regimen of brushing and rinsing with essential oil containing alcohol free mouthwashes versus a control.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
169
Subjects will brush and rinse with their assigned mouthwash twice daily.
Subjects will brush and rinse with their assigned mouthwash twice daily.
Subjects will brush and rinse with their assigned mouthwash twice daily.
Salus Research, Inc.
Fort Wayne, Indiana, United States
Change in baseline in oral tolerance based on oral hard and soft tissue exams
Change in baseline in oral tolerance based on oral hard and soft tissue exams will be reported. Oral examinations will be conducted to monitor oral hard and soft tissues tolerance to the treatments. Buccal and sublingual mucosae, lips/labial mucosa, mucobuccal gold, gingiva, tongue, hard and soft palate, uvula, oropharynx, teeth and dental restorations will be examined and findings will be recorded in the electronic data capture (EDC) system.
Time frame: Up to Day 14
Number of Participants with Adverse Events (AEs)
An AE is any untoward medical occurrence in a clinical study participant temporarily associated with the clinical investigation, whether or not the event has a causal relationship to the participant's participation in the trial.
Time frame: Up to Day 14
Mouthwash Habits Baseline Questionnaire
For the Mouthwash Habits Baseline Questionnaire, the number and percentage of subjects for each response of each question will be presented by investigational product group. For these aggregated response categories, percentages of subjects will be compared between investigational product groups using a chi-square test, or Fisher's exact test if the expected cell size is sufficiently small. For ordinal response questions (9-point Liking scales and 5-point scales), the mean and standard deviation for each ordinal response variable will also be displayed. Each statistical test will be carried out at the 0.10 level of significance, two-sided. Note that testing at the 0.10 level of significance is reasonable for consumer perception testing, as decisions based on these types of data are typically based on this significance level.
Time frame: Visit 1 (Day 0)
Product Perception Claims Questionnaire
For the Product Perception Claims Questionnaire, the number and percentage of subjects for each response of each question will be presented by investigational product group. For these aggregated response categories, percentages of subjects will be compared between investigational product groups using a chi-square test, or Fisher's exact test if the expected cell size is sufficiently small. For ordinal response questions (9-point Liking scales and 5-point scales), the mean and standard deviation for each ordinal response variable will also be displayed. Each statistical test will be carried out at the 0.10 level of significance, two-sided. Note that testing at the 0.10 level of significance is reasonable for consumer perception testing, as decisions based on these types of data are typically based on this significance level.
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Time frame: Visit 3 (Day 14 ± 1 day)
Comparison of the salivary microbial counts
Time frame: Visit 1 (Day 0); Visit 3 (Day 14 ± 1 day)