Trial Review

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Trial registered on ANZCTR


Registration number
ACTRN12608000251325
Ethics application status
Approved
Date submitted
16/05/2008
Date registered
19/05/2008
Date last updated
19/05/2008
Type of registration
Retrospectively registered

Titles & IDs
Public title
alpha lipoic acid in burning mouth syndrome:a randomized double-blind placebo-controlled crossover trial
Scientific title
The effect of alpha lipoic acid in the management of burning mouth syndrome
Universal Trial Number (UTN)
Trial acronym
Linked study record

Health condition
Health condition(s) or problem(s) studied:
burning mouth syndrome 3154 0
Condition category
Condition code
Neurological 3311 3311 0 0
Other neurological disorders

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
therapy with alpha lipoic acid orally, three capsules of 200 mg per day during 30 days
There was a washout period of 20 days
Intervention code [1] 2887 0
Treatment: Drugs
Comparator / control treatment
cellulose starch orally– 100 mg , three capsules per day during 30 days in identical capsules
Control group
Placebo

Outcomes
Primary outcome [1] 4213 0
this study failed to demonstrate effectiveness for alpha lipoic acid over placebo
Timepoint [1] 4213 0
30 days
Secondary outcome [1] 7129 0
secondary oral complaints dry mouth and disgeusia were observed in mostly of the patients
Timepoint [1] 7129 0
30 days

Eligibility
Key inclusion criteria
burning mouth for 6 months or more, absence of oral mucosal lesions, absence of sistemic conditions whose could produce burning mouth
Minimum age
30 Years
Maximum age
No limit
Sex
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
oral burning under 6 months sistemic diseases (anemia and diabetes) oral mucosal diseases, hypossalivation

Study design
Purpose of the study
Treatment
Allocation to intervention
Randomised controlled trial
Procedure for enrolling a subject and allocating the treatment (allocation concealment procedures)
sealed opaque envelopes
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Simple randomisation by using a randomization table created by a computer software (i.e., computerised sequence generation)
Masking / blinding
Blinded (masking used)
Who is / are masked / blinded?



Intervention assignment
Crossover
Other design features
washout period of 20 days
Phase
Phase 4
Type of endpoint/s
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Completed
Date of first participant enrolment
Anticipated
25/06/2006
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
31
Accrual to date
Final
Recruitment outside Australia
Country [1] 968 0
Brazil
State/province [1] 968 0

Funding & Sponsors
Funding source category [1] 3385 0
Government body
Name [1] 3385 0
Fundacao de Amparo a Pesquisa do estado de sao paulo
Country [1] 3385 0
Brazil
Primary sponsor type
Government body
Name
Fundacao de Amparo a Pesquisa do estado de sao paulo
Address
R. Pio XI, 1500 - Alto da Lapa
Sao Paulo
Country
Brazil
Secondary sponsor category [1] 3041 0
University
Name [1] 3041 0
University of Sao Paulo
Address [1] 3041 0
Av Prof Lineu Prestes, 2227
Cidade Universitaria
Sao Paulo
Country [1] 3041 0
Brazil
Other collaborator category [1] 288 0
Individual
Name [1] 288 0
Fernando ricardo xavier da silveira
Address [1] 288 0
r lineu prestes 2227
cidade universit?ria sao paulo
Country [1] 288 0
Brazil

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 5414 0
Ethical comittee in human research of the dentistry school university of sao paulo
Ethics committee address [1] 5414 0
rua prof lineu prestes,2227 cidade universitaria sao paulo
Ethics committee country [1] 5414 0
Brazil
Date submitted for ethics approval [1] 5414 0
Approval date [1] 5414 0
03/11/2005
Ethics approval number [1] 5414 0

Summary
Brief summary
The purpose of this study was to evaluate the effectiveness of alpha lipoic acid as an alternative in the management of burning mouth syndrome
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 28591 0
Address 28591 0
Country 28591 0
Phone 28591 0
Fax 28591 0
Email 28591 0
Contact person for public queries
Name 11748 0
desiree rosa cavalcanti
Address 11748 0
rua zilda valle rudge, 315 alto do ipiranga
mogi das cruzes são paulo
Country 11748 0
Brazil
Phone 11748 0
55 11 9907 6709
Fax 11748 0
Email 11748 0
dcavalcanti@usp.br
Contact person for scientific queries
Name 2676 0
desiree rosa cavalcanti
Address 2676 0
rua zilda valle rudge, 315 alto do ipiranga
mogi das cruzes são paulo
Country 2676 0
Brazil
Phone 2676 0
55 11 9907 6709
Fax 2676 0
Email 2676 0
dcavalcanti@usp.br

No information has been provided regarding IPD availability


What supporting documents are/will be available?

No Supporting Document Provided



Results publications and other study-related documents

Documents added manually
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Documents added automatically
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