Xerostomia affects at least a quarter of the population. This prevalence is increased in postmenopausal women and people over 65 years of age. Associated with age are systemic diseases such as Sjögren's Syndrome, diabetes, Parkinson's disease or cancer. It handicaps the patient in his social life, but also in terms of his well-being by the consequences it generates in the oral cavity. This dryness may be the consequence of taking certain medications, head and neck radiotherapy, but also being a symptom of an underlying pathology whose screening will allow early treatment and avoid complications. Today, no single therapeutic solution is enough and patients are waiting for new therapeutic innovations in this area. This study proposes to evaluate the tolerance of an adhesive film containing prebiotics by comparing it to a placebo control film.
The purpose of this study is to evaluate the tolerance of an adhesive film containing prebiotics on the improvement of signs and symptoms related to dry mouth by comparing it to a placebo film. The primary endpoint is the assessment of tolerability assessed using a visual analogue scale (VAS) from 0 to 100 at the end of the 1-month period of both treatment periods (D30 and D90). In this study, the efficacy and tolerance of the adhesive film containing prebiotics will be analyzed. Each participant in this study will receive two galenic forms of the medical device whose allocation order was previously defined by a randomization list.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Enrollment
10
It's a natural film which contains a concentrated alpha-GOS (alpha-galacto-oligosaccharide) soy extract, a milk protein concentrate containing caseins and whey proteins and vegetable glycerin
It's a natural film which is devoided of active ingredient. It contains sodium alginate; vegetable glycerin, caramel, beta carotene and water.
CHRU Brest
Brest, France
Tolerance evaluation
The primary endpoint is a composite endpoint of tolerance evaluation defined by: * the patient (EVA from 0 to 100), * the investigator (degree of redness and inflammation of the mucous membranes opposite the site of the device, * reporting adverse events related to the device
Time frame: day 90
Oral comfort
Self-evaluation of the patient's oral dryness (oral comfort) using a 100mm visual analogue scale (measurement of the absolute variation at the beginning and end of each treatment period)
Time frame: day 90
Subjective evaluation of dry mouth
Subjective evaluation of the absolute variation of the specific signs and symptoms of dry mouth (difficulty speaking, chewing swallowing, taste alteration, burning sensations) using 100 mm analogue visual scales
Time frame: day 90
Clinical assessment of the mucous
Objective clinical assessment of the general condition of the mucous membranes (redness, dryness, degree of inflammation of periodontal tissues, mucous membranes,...)
Time frame: day 90
Evaluation of salivary flow
Objective evaluation of the absolute variation of the stimulated and unstimulated salivary flow rates according to the dosage forms used and the variation of the oral pH using specific strips.
Time frame: day 90
Evaluation of the salivary microbiota
Evaluation by molecular sequencing of the salivary microbiota to study the impact of the film on the modification of the salivary microbiota (quantification of the different species by NGS)
Time frame: day 90
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