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Completed

NCT Number: NCT00350350

OGT Spray in the Management of Xerostomia in the Elderly

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).

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Key information

Age range

70 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

clinique Léopold Bellan

Magnanville, Yvelines, 78200, France

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

oxygenated oil

Device

oxygenated oil in spray versus product reference (artificial saliva) dosage : one to two spray 5 times a day

Other names: artificial saliva

medical device. Spray containing essentially oxygenated oil

Device

protective oral spray containing :

  • 94.4% of oxygenated oil
  • Silicium dioxide
  • aspartame artificial flavoring

Other names: artificial saliva

Sponsors and collaborators

Lead sponsor

Laboratoires CARILENE

Industry

Collaborators

  • Eurofins Dermscan Pharmascan

Registry information

Official study 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

Important dates

Study start
2003
Primary completion
2004
Study completion
2004
First posted
Jul 10, 2006
Registry last updated
Apr 23, 2012

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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