Early Phase Study Comparing the Effectiveness of a Dairy Product With the Reference Treatment Aequasyal® on Dry Mouth Symptoms in Patients Suffering From Xerostomia Caused by Psychotropic Medications.
- Conditions
- Xerostomia
- Interventions
- Other: Dairy productDevice: Aequasyal mouth spray
- Registration Number
- NCT02705937
- Lead Sponsor
- Centre Hospitalier Universitaire de Besancon
- Brief Summary
Dry mouth symptoms mostly occur as drug side-effects. Available products such as saliva substitutes are disappointing (bad taste, poor efficiency).
The hypothesis stems from the "empirical" observations that many patients alleviate dry mouth symptoms by the consumption of dairy products. Through its composition, the dairy product in itself provides relief for the patient, due both to its physical and biochemical properties, which could explain these observed improvements, and to elements related to the phenomena of consumption of food as an alternative to medication. In the latter case, hedonism takes on a role which has not been previously assessed. Initial work undertaken with the department of applied research at the National Dairy Industry School (ENIL) led to the prototyping of a new milk product, to qualify and adapt a product with a "health benefit" in patients suffering from xerostomia.
This dairy product has specific taste, texture and lubrication properties and will be tested in a randomized controlled cross-over study for its efficiency and acceptability versus a reference product (Aequasyal ®, Oxidized Glycerol Triester) on a group of 32 patients at Dijon and at Besançon University Hospitals.
This way of combatting xerostomia at the interface of patients' diet, such as it is proposed here, could help improve their quality of life, minimize harmful effects (infection, decay) and promote adherence to treatments which are responsible for xerostomia.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- UNKNOWN
- Sex
- All
- Target Recruitment
- 32
- Patients over 18 years old
- Patients seen in the psychiatry department requiring the prescription of psychotropic drugs (antidepressants anxiolytics) for over 6 weeks
- Patients complaining of xerostomia
- Patients having not taken a palliative therapy against xerostomia for at least 2 weeks
- Patients having signed a free and informed consent form
- Patients affiliated to a social security system
- Patients suffering from psychotic illness
- Patients suffering from Sjogren's syndrome
- Patients having been treated by radiation therapy for head or neck cancer
- Patients having stopped a palliative therapy against xerostomia for less than 2 weeks
- Patients under 18
- Pregnant or Breastfeeding women
- Incapacitated adults
- Patients placed under tutorship or curatorship
- Patients under judicial protection
- Patients suffering from milk allergy or lactose intolerance
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Dairy product Dairy product The product will be taken for 14 days Aequasyal mouth spray medical device Aequasyal mouth spray The spray will be taken for 14 days
- Primary Outcome Measures
Name Time Method Comparison of changes in mouth Dryness Score Score measured at day 0, day 14, Day 21 and day 35 Change (in centimeters measured on a Visual Analogue Scale) determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21
- Secondary Outcome Measures
Name Time Method Salivary flow Measured at day 0, day 14, Day 21 and day 35 Change determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21
Difficulty in chewing Score measured at day 0, day 14, Day 21 and day 35 Change (in centimeters measured on a Visual Analogue Scale) determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21
Difficulty in swallowing Score measured at day 0, day 14, Day 21 and day 35 Change (in centimeters measured on a Visual Analogue Scale) determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21
Difficulty in speaking Score measured at day 0, day 14, Day 21 and day 35 Change (in centimeters measured on a Visual Analogue Scale) determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21
Burning sensation Score measured at day 0, day 14, Day 21 and day 35 Change (in centimeters measured on a Visual Analogue Scale) determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21
Saliva pH Measured at day 0, day 14, Day 21 and day 35 Change determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21
Taste perception Score measured at day 0, day 14, Day 21 and day 35 Change (in centimeters measured on a Visual Analogue Scale) determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21
Silness-Loe Index measuring dental plaque Measured at day 0, day 14, Day 21 and day 35 Change determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21
Trial Locations
- Locations (1)
CHU de Besancon
🇫🇷Besançon, France