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OGT Spray in the Management of Xerostomia in the Elderly

This study has been completed.
Sponsor:
Collaborator:
DERMSCAN-PHARMASCAN GROUP in charge of data analysis
Information provided by (Responsible Party):
Laboratoires CARILENE
ClinicalTrials.gov Identifier:
NCT00350350
First received: July 6, 2006
Last updated: April 20, 2012
Last verified: July 2006
History of Changes
  Purpose

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).


Condition Intervention Phase
XEROSTOMIA
 Device: oxygenated oil
Device: medical device. Spray containing essentially oxygenated oil
 Phase 3

Study Type: Observational
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

Resource links provided by NLM:

MedlinePlus related topics: Dry Mouth
U.S. FDA Resources

Further study details as provided by Laboratoires CARILENE:

Enrollment: 74
Study Start Date: October 2003
Study Completion Date: December 2004
Primary Completion Date: November 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
elderly people
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 saliva
Device: medical device. Spray containing essentially oxygenated oil

protective oral spray containing :

  • 94.4% of oxygenated oil
  • Silicium dioxide
  • aspartame artificial flavoring
Other Name: artificial saliva

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.

  Eligibility

Ages Eligible for Study:   70 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population

elderly population at least 70 years old residents of old's people homes

Criteria

Inclusion Criteria:

  • male or female, institutionalized and at least 70 years of age
  • with a diagnosis of xerostomia confirmed objectively by the saliva absorption test
  • having stopped all palliative treatment for xerostomia
  • legally capable of giving consent
  • capable and agreeing to participate in the study and capable and accepting to answer study questionnaires in accordance with the terms of the French Huriet Act on clinical trials,
  • remaining in the establishment throughout the study period

Exclusion Criteria:

  • Concomitant treatments incompatible with the trial, especially alcoholic solutions
  • buccal fungal infection
  • systemic infection or current dental care
  • current participation in other clinical trials
  • allergy or known intolerance to one of the constituents of the trial products
  • treatment with atropine
  • presence of active life-threatening disease
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00350350

Locations
France
clinique Léopold Bellan
Magnanville, Yvelines, France, 78200
Sponsors and Collaborators
Laboratoires CARILENE
DERMSCAN-PHARMASCAN GROUP in charge of data analysis
Investigators
Principal Investigator: Michel MS SALOM, Gerontologis Clinique Leopold Bellan 78200 Magnanville, France
  More Information

Publications:

Responsible Party: Laboratoires CARILENE
ClinicalTrials.gov Identifier: NCT00350350     History of Changes
Other Study ID Numbers: CARILENE LABORATORY
Study First Received: July 6, 2006
Last Updated: April 20, 2012
Health Authority: France: Ministry of Health

Keywords provided by Laboratoires CARILENE:
XEROSTOMIA
MOUTH DRYNESS
ELDERLY
ORAL LUBRICANT

Additional relevant MeSH terms:
Xerostomia
Salivary Gland Diseases
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on June 18, 2013