Ignite Creation Date:
2024-05-05 @ 4:58 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00350350
Status:
COMPLETED
Last Update Posted:
2012-04-23
First Post:
2006-07-06
Brief Title:
OGT Spray in the Management of Xerostomia in the Elderly
Sponsor:
Laboratoires CARILENE
Organization:
Laboratoires CARILENE
Study Overview
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
Status:
COMPLETED
Status Verified Date:
2006-07
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
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
Detailed Description:
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
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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None