OGT Spray in the Management of Xerostomia in the Elderly
The primary objective of the trial is to evaluate the efficacy, safety and clinical acceptability of OGT oromucosal spray in the relief of symptoms and signs of xerostomia in comparison with a saliva substitute (European Medical Device).
Device: oxygenated oil
Device: medical device. Spray containing essentially oxygenated oil
|Study Design:||Observational Model: Cohort
Time Perspective: Prospective
|Official Title:||Multicenter, Controlled Parallel Groups Trial to Evaluate the Efficacy, Safety and Acceptability of OGT Oromucosal Spray Versus a Saliva Substitute in the Treatment of Xerostomia in Geriatrics|
|Study Start Date:||October 2003|
|Study Completion Date:||December 2004|
|Primary Completion Date:||November 2004 (Final data collection date for primary outcome measure)|
elderly people over 70 years residents of old's people homes with symptoms of dry mouth
Device: oxygenated oil
oxygenated oil in spray versus product reference (artificial saliva) dosage : one to two spray 5 times a day
Other Name: artificial salivaDevice: medical device. Spray containing essentially oxygenated oil
protective oral spray containing :
Other Name: artificial saliva
Xerostomia is excessive dryness of the mouth. It is due to insufficient (hyposialism) or inexistent (asialia) saliva secretion.
There are many 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.
Xerostomia is often accompanied by buccal symptoms and signs such as impaired sense of taste, fetid breath and mouth ulcers, and it disturbs functions such as speech, chewing and swallowing. Because of reduced salivary secretion, there is disturbance of the microbial colonization of the buccal cavity, increased demineralization and decreased remineralization of the teeth, impaired retention of dentures, dehydration of the mucosa and reduced lubrication of the buccal mucosa. These complications may take the form of dental caries, candidiasis, atrophy and feelings of burning of the mucosa, difficulty retaining dentures, impaired speech and swallowing and impression of decreased or impaired sense of taste. Xerostomia has significant harmful effects on the buccal cavity and on the quality of life of patients.
Xerostomia prevalence rates of the order of 18-61% have been reported in the elderly. These rates are generally higher in women that in men and increase with age. They are also higher in populations in institutions and in those taking multiple medications. Wearing a denture, stress and other psychological factors have also been suggested as factors increasing risk or or worsening xerostomia.
Treatments of xerostomia are saliva substitutes and saliva stimulants.
OGT Spray is neither a substitute nor stimulant of saliva.
OGT Spray is a solution for oromucosal spray which has lubricant and protective actions.
The aim of the study was to demonstrate that OGT Spray (oral lubricant) was effective in the subjective relief of dry mouth symptoms and objective signs of dry mouth in elderly.
|clinique Léopold Bellan|
|Magnanville, Yvelines, France, 78200|
|Principal Investigator:||Michel MS SALOM, Gerontologis||Clinique Leopold Bellan 78200 Magnanville, France|