Xerostomia Clinical Trial
Official title:
Multicenter Controlled Parallel-Groups Trial to Evaluate the Efficacy, Safety and Acceptability of TGO Buccal Spray Versus a Saliva Substitute in the Treatment of Psychotropic Medicines-Induced Xerostomia
The objective of the trial was to evaluate the efficacy and clinical safety and acceptability of Oxygenated Glycerol Triesters in the relief of symptoms of xerostomia versus a reference comparator.
Xerostomia is due to inadequate (hyposialia) or inexistent (asialia) saliva secretion.
There are may causes. Transitory xerostomia may occur in the presence of anxiety (stage
fright, fear or dehydration). Prolonged xerostomia is most often related to a systemic
disease, certain medicines or to radiotherapy of the head or neck.
Salivation depends upon the autonomic (sympathetic and parasympathetic) nervous system for
its production and on the central nervous system for stimuli-dependant excretion. Substances
acting on alpha an beta sympathetic receptors, whether agonists or antagonists, may induce
hyposialia. Atropine, the main antagonist of the parasympathetic system, is present in many
medicines used for pulmonary, ophthalmic or neurological purposes, potentially causing
hyposialia. Similarly, imipramine antidepressants, phenothiazine neuroleptics,
antihistamines and disopyramide predispose to the onset of hyposialia.
Xerostomia is often accompanied by buccal signs such as impaired sense of taste, halitosis
and buccal ulcers and interferes with functions such as speech, chewing and swallowing.
Because of reduced salivary secretion , there is a disturbance of the microbial colonization
of the buccal cavity. Xerostomia has significant untoward effects on the buccal cavity and
the quality of life of patients.
The basis of the treatment of xerostomia involves the use of saliva substitutes and/or
saliva stimulants. Oxygenated Glycerol Triesters is neither a replacement for nor stimulant
of saliva. It is a lubricant and protective solution for endobuccal spray.
;
Observational Model: Defined Population, Primary Purpose: Screening, Time Perspective: Cross-Sectional
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 |
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 | |
Recruiting |
NCT02705937 -
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.
|
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 |