Xerostomia Clinical Trial
Official title:
Early Phase Study Comparing the Effectiveness of a Dairy Product, Co-developed by Besancon University Hospital and the National School of Dairy Industry (ENIL), With the Reference Treatment Aequasyal® on Dry Mouth Symptoms in Patients Suffering From Xerostomia Caused by Psychotropic Medications.
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.
n/a
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT05342272 -
Comparison of Gum® HydralTM Moisturizing Gel and Biotene® Oral Gel in Dry Mouth Sensation Reduction
|
Phase 3 | |
| Completed |
NCT03302676 -
The Use of Chewing Gum for Xerostomia and Hyposalivation After Radiotherapy for Oral and Oropharyngeal Tumors
|
N/A | |
| Completed |
NCT02375451 -
Effect of Childhood Radioiodine Therapy on Salivary Function
|
N/A | |
| Completed |
NCT01272570 -
Oral Health and Oral Health-Related Quality of Life in Early Stage Breast Cancer Survivors
|
N/A | |
| Completed |
NCT00656513 -
Acupuncture-Like Transcutaneous Electrical Nerve Stimulation (ALTENS) or Pilocarpine in Treating Early Dry Mouth in Patients Undergoing Radiation Therapy for Head and Neck Cancer
|
Phase 2/Phase 3 | |
| Completed |
NCT00911768 -
Effect of Korean Red Ginseng (KRG) on Dry Mouth
|
Phase 4 | |
| Completed |
NCT00332618 -
Efficacy Study of Oxygenated Glycerol Triesters to Treat Xerostomia
|
Phase 2 | |
| Completed |
NCT03494985 -
A Clinical Study to Evaluate the Efficacy of Three Dry Mouth Relief Products Versus Water
|
N/A | |
| Completed |
NCT05058430 -
SaliPen Human Factors Study for OTC Labeling
|
N/A | |
| Completed |
NCT05247008 -
Effectiveness of Thyme Honey in Management of Xerostomia in ESRD
|
N/A | |
| Recruiting |
NCT03632096 -
Photobiomodulation in Salivary Production of Patients With Xerostomy
|
Phase 2 | |
| Not yet recruiting |
NCT04323384 -
The Effect of Biotene® on the Symptoms of Xerostomia and Mastication and Swallowing
|
N/A | |
| Not yet recruiting |
NCT03530735 -
Finger-prick Autologous Blood (FAB) for Use in Dry Mouth
|
N/A | |
| Active, not recruiting |
NCT03176368 -
Coconut Oil: Managing Radiation-Induced Xerostomia
|
N/A | |
| Enrolling by invitation |
NCT06122636 -
Efficacy of a Probiotic and Microbiological Analysis on Oral Complications Induced by Antineoplastic Therapies in Patients With HNC
|
N/A | |
| Completed |
NCT03611283 -
Topical Management of Xerostomia With Dry Mouth Products
|
N/A | |
| Completed |
NCT02682199 -
Prospective Evaluation of Patient Reported Xerostomia After Whole Brain Radiation
|
||
| Withdrawn |
NCT01960101 -
Development of a Milk Product Substitution for Patients Suffering From Xerostomia Caused by Medication
|
N/A | |
| Completed |
NCT02317172 -
Efficacy of Novel Edible Gel-based Artificial Saliva in Thai Geriatric Populations With Systemic Diseases
|
N/A | |
| Completed |
NCT00350350 -
OGT Spray in the Management of Xerostomia in the Elderly
|
Phase 3 |