OGT Spray in the Management of Xerostomia in the Elderly
|The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.|
|ClinicalTrials.gov Identifier: NCT00350350|
Recruitment Status : Completed
First Posted : July 10, 2006
Last Update Posted : April 23, 2012
|Condition or disease||Intervention/treatment||Phase|
|XEROSTOMIA||Device: oxygenated oil Device: medical device. Spray containing essentially oxygenated oil||Phase 3|
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.
|Study Type :||Observational|
|Actual Enrollment :||74 participants|
|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|
|Primary Completion Date :||November 2004|
|Study Completion Date :||December 2004|
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
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00350350
|clinique Léopold Bellan|
|Magnanville, Yvelines, France, 78200|
|Principal Investigator:||Michel MS SALOM, Gerontologis||Clinique Leopold Bellan 78200 Magnanville, France|