The purpose of this study is to evaluate the clinical efficacy, safety and acceptability of our new oral salivary equivalent in the relief of signs and symptoms related to mouth dryness as compared to two distinct moisturizing currently marketed oral sprays (Aequasyal® \& Biotene®) in patients with xerostomia due to chronic hyposalivation.
National, multicentre, randomised, active controlled, crossover, open-label study using a 3-latin-square design. 200 evaluable patients have been recruited
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
210
14-day treatment with salivary equivalent sticks
14-day treatment with Aequasyal oral spray
14-day treatment with Biotene oral spray
Leopold Bellan Private Hospital
Magnanville, France
Dry mouth discomfort
Patient evaluation through the completion of a self rated 100 mm long VAS score. Anchor points of the VAS score will be 0 representing the absence of any dry mouth symptoms and 100 representing the worst imaginable picture of dry mouth discomfort
Time frame: 14 days
Mouth burning sensation
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Time frame: 14 days
Speech difficulties
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Time frame: 14 days
Chewing difficulties
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Time frame: 14 days
Swallowing difficulties
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Time frame: 14 days
Taste perversion
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Time frame: 14 days
Medical device acceptability
Patient evaluation through the completion of a self rated 100 mm long VAS score.
Time frame: 14 days
Medical device safety assessment
Patient evaluation through the completion of a self rated 100 mm long VAS score.
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Time frame: 14 days