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Trial registered on ANZCTR


Registration number
ACTRN12609000460202
Ethics application status
Approved
Date submitted
28/05/2009
Date registered
16/06/2009
Date last updated
16/06/2009
Type of registration
Retrospectively registered

Titles & IDs
Public title
Denture Stomatitis: cetylpyridinium chloride treatment with control group
Scientific title
Denture stomatitis patients treated with cetiypyridinium chloride mouthwashes compared to a control group in order to assess its efficacy
Universal Trial Number (UTN)
Trial acronym
DS-CPC
Linked study record

Health condition
Health condition(s) or problem(s) studied:
Denture Stomatitis 4871 0
Condition category
Condition code
Oral and Gastrointestinal 237223 237223 0 0
Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon

Intervention/exposure
Study type
Interventional
Description of intervention(s) / exposure
Once stablished the diagnosis of denture stomatitis, patients will be randomly allocated to one of two experimental groups. All patients will receive hygiene instructions and asked to avoid nocturnal use of their prosthesis. An appropriate toothbrush will be provided and a proper hygiene technique will be demonstrated and practiced once at the start of trial and reinforced at each control appointment. Test group will be given cetylpyridinium chloride and directions to mouthwash 3 times daily, during one minute, three weeks long. Control group will be followed with no other intervention but the hygiene instructions.
Intervention code [1] 236659 0
Treatment: Drugs
Comparator / control treatment
Control group will be followed with no other intervention for three weeks also.
Control group
Active

Outcomes
Primary outcome [1] 238036 0
Clinical improvement, measured according to the clinical parameters initially stablished - intensity and extent of mucosal erythema. Erythema intensity will be classified according to a coloured scale of eight grades varying from pale pink to bloody red. Extension of erythema will be objectively measured in square centimeters with the aid of digitized pictures and categorized in four classes: up to 25%; between 25 and 50%; between 50 and 75% and above 75% of the palate mucosa involved.
Timepoint [1] 238036 0
starting date, day 21, day 35
Secondary outcome [1] 242197 0
Colony forming units will be counted in Petri dishes with appropriate medium for growing Candida species. Sample collection will be performed with cytobrushes from palate mucosa and the prosthesis basis. These samples will be progressive diluted and dispensed in drops on the Petri dishes. Dishes will be incubated at 37oC to be read in 24, 48 and 72 hours.
Timepoint [1] 242197 0
starting date, day 21, day 35

Eligibility
Key inclusion criteria
Removable dental prosrthesis wearers
Proper diagnosis of denture stomatitis
Minimum age
No limit
Maximum age
No limit
Gender
Both males and females
Can healthy volunteers participate?
No
Key exclusion criteria
No history of antifungal use in the last 6 months
Negative medical history for radiotherapy, chemotherapy or immunodeficiency

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)
Elegible patients will be properly instructed and asked to sign an Informed Consent. Every patient will be treated, through hygiene instructions and changing in the habits of prosthesis utilization. Test group will additionally use a cetylpyridinium chloride mouthwash. One researcher will be responsible for enrolling the sibjects and generate the sequence of allocation. The clinical researcher will receive the patient, open the sealed envelope with the allocation group and proceed with the methodology as a control or test group patient.
Methods used to generate the sequence in which subjects will be randomised (sequence generation)
Allocation between the two groups will be randomized with the aid of a computer program.
Masking / blinding
Open (masking not used)
Who is / are masked / blinded?



Intervention assignment
Parallel
Other design features
Phase
Not Applicable
Type of endpoint(s)
Efficacy
Statistical methods / analysis

Recruitment
Recruitment status
Active, not recruiting
Date of first participant enrolment
Anticipated
Actual
Date of last participant enrolment
Anticipated
Actual
Date of last data collection
Anticipated
Actual
Sample size
Target
Accrual to date
Final
Recruitment outside Australia
Country [1] 1811 0
Brazil
State/province [1] 1811 0

Funding & Sponsors
Funding source category [1] 5039 0
University
Name [1] 5039 0
Sao Paulo University
Address [1] 5039 0
Av Prof Lineu Prestes, 2227
Cidade Universitaria
Sao Paulo
CEP 05508-000
Country [1] 5039 0
Brazil
Primary sponsor type
University
Name
Sao Paulo University
Address
Av Prof Lineu Prestes, 2227
Cidade Universitaria
Sao Paulo
CEP 05508-000
Country
Brazil
Secondary sponsor category [1] 4553 0
None
Name [1] 4553 0
Address [1] 4553 0
Country [1] 4553 0

Ethics approval
Ethics application status
Approved
Ethics committee name [1] 239135 0
Research Ethics Committee of Sao Paulo University School of Dentistry
Ethics committee address [1] 239135 0
Av Prof Lineu Prestes, 2227
Cidade Universitaria
Sao Paulo
CEP 05508-000
Ethics committee country [1] 239135 0
Brazil
Date submitted for ethics approval [1] 239135 0
Approval date [1] 239135 0
12/05/2008
Ethics approval number [1] 239135 0

Summary
Brief summary
The main purpose of the trial is to verify the efficacy of cetylpyridinium chloride mouthwashes in the treatment of denture stomatitis utilizing as outcome measures clinical and micological parameters, i.e., extent and intensity of mucosal erythema and colony forming units of Candida species.
Trial website
Trial related presentations / publications
Public notes

Contacts
Principal investigator
Name 29660 0
Address 29660 0
Country 29660 0
Phone 29660 0
Fax 29660 0
Email 29660 0
Contact person for public queries
Name 12907 0
Juliana Seo
Address 12907 0
Alha Elias Abibe Street, 65
Parque dos Principes
Osasco
Postal Code: 06030-300
Country 12907 0
Brazil
Phone 12907 0
+55 11 35910033
Fax 12907 0
Email 12907 0
juseo@uol.com.br
Contact person for scientific queries
Name 3835 0
Norberto Nobuo Sugaya
Address 3835 0
Av Prof Lineu Prestes, 2227
Cidade Universitaria
Sao Paulo
CEP 05508-000
Country 3835 0
Brazil
Phone 3835 0
+55 11 30917883
Fax 3835 0
+55 11 30917883
Email 3835 0
nnsugaya@usp.br

No information has been provided regarding IPD availability
Summary results
Have study results been published in a peer-reviewed journal?
Other publications
Have study results been made publicly available in another format?
Results – basic reporting
Results – plain English summary