OGT Spray in the Management of Xerostomia in the Elderly

April 20, 2012 updated by: Laboratoires CARILENE

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

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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.

Study Type

Observational

Enrollment (Actual)

74

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • France
    • Yvelines
      • Magnanville, Yvelines, France, 78200
        • Clinique Léopold Bellan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

66 years and older (Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
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 Names:
  • 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 Names:
  • artificial saliva

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Laboratoires CARILENE

Collaborators

DERMSCAN-PHARMASCAN GROUP in charge of data analysis

Investigators

  • Principal Investigator: Michel MS SALOM, Gerontologis, Clinique Leopold Bellan 78200 Magnanville, France

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2003

Primary Completion (Actual)

November 1, 2004

Study Completion (Actual)

December 1, 2004

Study Registration Dates

First Submitted

July 6, 2006

First Submitted That Met QC Criteria

July 6, 2006

First Posted (Estimate)

July 10, 2006

Study Record Updates

Last Update Posted (Estimate)

April 23, 2012

Last Update Submitted That Met QC Criteria

April 20, 2012

Last Verified

July 1, 2006

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • CARILENE LABORATORY

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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