Efficacy Study of Oxygenated Glycerol Triesters to Treat Xerostomia
NCT ID: NCT00332618
Last Updated: 2006-06-07
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
74 participants
OBSERVATIONAL
2003-09-30
2004-04-30
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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DEFINED_POPULATION
OTHER
Interventions
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OXYGENATED GLYCEROL TRIESTERS
Eligibility Criteria
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Inclusion Criteria
* with a diagnosis requiring the prescription of psychotropies (antidepressants, tranquilizers, etc) for more than 6 weeks
* having received no palliative treatment for xerostomia for a minimum of the past 2 weeks
* having xerostomia meeting the questionnaire selection criteria and the sialometer method parameters
* patients legally competent to give their consent
* capable of and accepting to participate in the trial and capable of and accepting to answer trial questionnaires
Exclusion Criteria
* diabetes, any buccal condition requiring antimicrobial treatment
* Sjögren's syndrome or othermedical causes of xerostomia
* current participation in other clinical trials
* patient suffering from cancer
* patients with allergy to or known intolerance of any of the constituents of the investigational products
* patients treated with pilocarpine
18 Years
ALL
No
Sponsors
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Laboratoires CARILENE
INDUSTRY
Principal Investigators
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YVES YT TILLET, Expertpharma
Role: STUDY_DIRECTOR
WHITE TILLET Consultants
Jean Baptiste JO Orler, Psychiatrist
Role: PRINCIPAL_INVESTIGATOR
CHU HOPITAL DES BROUSSAILLES
Locations
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Chu Hopital Des Broussailles
Cannes, , France
Countries
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References
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Fox PC. Management of dry mouth. Dent Clin North Am. 1997 Oct;41(4):863-75.
Other Identifiers
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Laboratoires CARILENE
Identifier Type: -
Identifier Source: org_study_id