OGT Spray in the Management of Xerostomia in the Elderly

NCT ID: NCT00350350

Last Updated: 2012-04-23

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 74 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2003-10-31
• Study Completion Date: 2004-12-31

Brief Summary

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).

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.

Conditions

XEROSTOMIA

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

elderly people

elderly people over 70 years residents of old's people homes with symptoms of dry mouth

oxygenated oil

Intervention Type: DEVICE

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

medical device. Spray containing essentially oxygenated oil

Intervention Type: DEVICE

protective oral spray containing :

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

Interventions

oxygenated oil

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

Intervention Type: DEVICE

medical device. Spray containing essentially oxygenated oil

protective oral spray containing :

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

Intervention Type: DEVICE

Other Intervention Names

artificial saliva; artificial saliva

Eligibility 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

• Minimum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Eurofins Dermscan Pharmascan

INDUSTRY

Sponsor Role: collaborator

Laboratoires CARILENE

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Michel MS SALOM, Gerontologis

Role: PRINCIPAL_INVESTIGATOR

Clinique Leopold Bellan 78200 Magnanville, France

Locations

clinique Léopold Bellan

Magnanville, Yvelines, France

Countries

France

References

Fox PC. Management of dry mouth. Dent Clin North Am. 1997 Oct;41(4):863-75.

Reference Type: BACKGROUND

PMID: 9344281 (View on PubMed)

Other Identifiers

CARILENE LABORATORY

Identifier Type: -

Identifier Source: org_study_id