Xerostomia
Conditions
Keywords
xerostomia, Saliva, iatrogenic oral dryness, dairy product
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.
Interventions
OTHERDairy product
Dairy products are given to patients with the instruction to eat as many products as necessary to provide them with some relief (within a limit of 6 per day) for 14 days
DEVICEAequasyal mouth spray
The mouth spray will be used by patients as needed (according to the package leaflet) for 14 days
Sponsors
Ecole Nationale de l'Industrie Laitière (ENIL)
Centre Hospitalier Universitaire Dijon
Centre Hospitalier Universitaire de Besancon
Study design
Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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
| Measure | Time frame | Description |
|---|---|---|
| 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 |
| 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 |
| 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 |
| 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 |
| 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 |
Countries
France
Contacts
Primary ContactNazim NEKROUF, MD
Backup ContactGaelle Brunotte, PharmD
Outcome results
None listed