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| Name | Class |
|---|---|
| Ecole Nationale de l'Industrie Laitière (ENIL) | UNKNOWN |
| Centre Hospitalier Universitaire Dijon | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Dairy product | Experimental | The product will be taken for 14 days |
|
| Aequasyal mouth spray medical device | Active Comparator | The spray will be taken for 14 days |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Dairy product | Other | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Comparison of changes in mouth Dryness Score | 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 | Score measured at day 0, day 14, Day 21 and day 35 |
| Measure | Description | Time Frame |
|---|---|---|
| Difficulty in chewing | 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 | Score measured at day 0, day 14, Day 21 and day 35 |
| Difficulty in swallowing |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Nazim NEKROUF, MD | Contact | 0033.3.81.21.82.75 | n1nekrouf@chu-besancon.fr | |
| Gaelle Brunotte, PharmD | Contact | gbrunotte@chu-besancon.fr |
| Name | Affiliation | Role |
|---|---|---|
| Nazim NEKROUF, MD | Besancon University Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| CHU de Besancon | Recruiting | Besançon | 25000 | France |
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| Aequasyal mouth spray | Device | The mouth spray will be used by patients as needed (according to the package leaflet) for 14 days |
|
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 |
| Score measured at day 0, day 14, Day 21 and day 35 |
| Difficulty in speaking | 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 | Score measured at day 0, day 14, Day 21 and day 35 |
| Burning sensation | 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 | Score measured at day 0, day 14, Day 21 and day 35 |
| Taste perception | 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 | Score measured at day 0, day 14, Day 21 and day 35 |
| Silness-Loe Index measuring dental plaque | Change determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21 | Measured at day 0, day 14, Day 21 and day 35 |
| Salivary flow | Change determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21 | Measured at day 0, day 14, Day 21 and day 35 |
| Saliva pH | Change determined between day 14 and day 0 will be compared to the change assessed between day 35 and day 21 | Measured at day 0, day 14, Day 21 and day 35 |
| ID | Term |
|---|---|
| D014987 | Xerostomia |
| ID | Term |
|---|---|
| D012466 | Salivary Gland Diseases |
| D009059 | Mouth Diseases |
| D009057 | Stomatognathic Diseases |
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| ID | Term |
|---|---|
| D003611 | Dairy Products |
| ID | Term |
|---|---|
| D005502 | Food |
| D000066888 | Diet, Food, and Nutrition |
| D010829 | Physiological Phenomena |
| D019602 | Food and Beverages |
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