XEROSTOMIANCT00350350
OGT Spray in the Management of Xerostomia in the Elderly
An observational study of XEROSTOMIA, run by Laboratoires CARILENE at 1 site in France.
Trial 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). Read more about this study
- Who is it for?
- Ages 70 years and older
- Conditions the study is for
- XEROSTOMIA
- What is being tested?
- oxygenated oil and medical device. Spray containing essentially oxygenated oil
- Type of treatment
- Pill or oral medicine, Medical device
- How many people
- 74 participants
- Where
- 1 siteFrance
- Study dates
- Oct 2003to Dec 2004
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 70 years and older
- All sexes
- No healthy volunteers
- Older adult
Study population: elderly population at least 70 years old residents of old's people homes
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
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
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).
Read the 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
- Being tested
- oxygenated oil, medical device. Spray containing essentially oxygenated oil
- Keywords
- XEROSTOMIA, MOUTH DRYNESS, ELDERLY, ORAL LUBRICANT
- Medical subject headings
- Xerostomia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
oxygenated oilDevice
Also called artificial saliva
oxygenated oil in spray versus product reference (artificial saliva) dosage : one to two spray 5 times a day
medical device. Spray containing essentially oxygenated oilDevice
Also called artificial saliva
protective oral spray containing :
- 94.4% of oxygenated oil
- Silicium dioxide
- aspartame artificial flavoring
| Study group | Role | What they receive |
|---|---|---|
| elderly people | elderly people over 70 years residents of old's people homes with symptoms of dry mouth Receives: Device: oxygenated oil; Device: medical device. Spray containing essentially oxygenated oil |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jul 2006 (estimated)
- Study startOct 2003
- Primary completionNov 2004
- Study completionDec 2004
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for XEROSTOMIAStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 74 participants (actual)
Sponsor and investigators
- Lead sponsor
- Laboratoires CARILENE
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Responsible party
- Sponsor
- Investigators
- Michel MS SALOM, Gerontologis, Principal investigator, Clinique Leopold Bellan 78200 Magnanville, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00350350
- Sponsor's protocol ID
- CARILENE LABORATORY
- Status last verified
- Jul 2006
- First submitted
- 6 Jul 2006
- Last updated
- 23 Apr 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Fox PC. Management of dry mouth. Dent Clin North Am. 1997 Oct;41(4):863-75.
PubMed 9344281
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT00350350
- Acronym / sponsor ID
- CARILENE LABORATORY
- Conditions
- XEROSTOMIA
- Keywords
- XEROSTOMIA, MOUTH DRYNESS, ELDERLY, ORAL LUBRICANT
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 74 participants (actual)
- Lead sponsor
- Laboratoires CARILENEIndustry (pharma, biotech, devices)
- Collaborators
- Eurofins Dermscan Pharmascan
- Study start
- Oct 2003
- Primary completion
- Nov 2004 (actual)
- Study completion
- Dec 2004 (actual)
- First posted
- 10 Jul 2006 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| elderly people | – | Device: oxygenated oil, Device: medical device. Spray containing essentially oxygenated oilelderly people over 70 years residents of old's people homes with symptoms of dry mouth |
Who may qualify
- Ages
- 70 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
- Study population
- elderly population at least 70 years old residents of old's people homes
Key inclusion criteria (6 listed)
- 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,
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| oxygenated oilAlso: artificial salivaoxygenated oil in spray versus product reference (artificial saliva) dosage : one to two spray 5 times a day | Device | elderly people |
| medical device. Spray containing essentially oxygenated oilAlso: artificial salivaprotective oral spray containing : * 94.4% of oxygenated oil * Silicium dioxide * aspartame artificial flavoring | Device | elderly people |
Primary outcome
Not reported in the source record.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2012.
- Background: PubMed 9344281Fox PC. Management of dry mouth. Dent Clin North Am. 1997 Oct;41(4):863-75.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Michel MS SALOM, Gerontologis principal investigator
Clinique Leopold Bellan 78200 Magnanville, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of XEROSTOMIA, run by Laboratoires CARILENE at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00350350, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Apr 2012.