Protocol summary

Summary
This study is the clinical part of chitosan effect in the treatment of fungal infections which is a continuation of laboratory studies and is consistent with the standards of material handling.Forty patients who wear full dentures with denture stomatitis type two, randomly selected by an examiner. Patients shouldn't give history of anti-fungal therapy, medicines that reduce saliva and history of immunosuppressive disease from a month ago.Patients, divided into two equal groups and first group should use mouth wash chitosan 1% four times a day, each time 2 ml, for two minutes untill two weeks. Another group should use Nystatin as exactly the same way.Palatal smear from infected areas will be obtained,four samples from each patient before and after treatment,Patient, wil physical examine in three stages (pre-treatment, one week later and after treatment) and will take photography.The samples will be analyzed mycologicly. Myslyal form, usually caused by denture stomatitis and blastospore form can be seen at the normal palatal mucosa.Accordingly,palatal smear containing mycelium, also based on clinical signs of infection,lack of erythematosus areas mean healing, reduce erythematosus areas mean relative improvement and no change means no improvement.Also, the patient's pain is a factor to assess recovery and The patient will be checked by completing the form Visual Analog Scale.

General information

Acronym
IRCT registration information
IRCT registration number: IRCT2015071223169N1
Registration date: 2015-08-08, 1394/05/17
Registration timing: registered_while_recruiting

Last update:
Update count: 0
Registration date
2015-08-08, 1394/05/17
Registrant information
Name
Negar Salehi
Name of organization / entity
Department of Oral Medicine of Kerman Dental School
Country
Iran (Islamic Republic of)
Phone
+98 34 3211 9023
Email address
n.salehi@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Research center of Oral Medicine of Kerman Dental School
Expected recruitment start date
2015-06-21, 1394/03/31
Expected recruitment end date
2016-04-19, 1395/01/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Clinical effects of chitosan solution in the treatment of denture stomatitis in the patients refer to the dental clinics of kerman
Public title
effects of chitosan solution in the treatment of fungal infection due to denture
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:patients who wear full dentures with denture stomatitis type two. exclusion criteria: Patients with experience of antifungal agents ; antibiotics ; corticosteroids ; medications that reduce saliva from a month earlier , and also patients with immunosuppressive diseases ; diabetes; masticatory muscle disorders ; Alzheimer's disease and psychological disorders.
Age
No age limit
Gender
Both
Phase
2
Groups that have been masked
No information
Sample size
Target sample size: 40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Single blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethic committee of Kerman Medical Science university
Street address
Kerman Medical Science Research center/Tahmasbabad squar/Kermane
City
Kerman
Postal code
Approval date
2015-04-07, 1394/01/18
Ethics committee reference number
AC.KMU.REC.1394.118

Health conditions studied

1

Description of health condition studied
Oral fungal infection
ICD-10 code
B37.0
ICD-10 code description
Candidal stomatitis

Primary outcomes

1

Description
Biological smear evaluation
Timepoint
Befor intervention/one week after intervention/end of secend week after intervention
Method of measurement
Nomber of candida colonies

2

Description
Pain
Timepoint
Every day from start to end of intervention
Method of measurement
Visual analog scale

3

Description
Clinical evaloation
Timepoint
Befor intervention/one week after intervention/end of secend week after intervention
Method of measurement
lesions diameter (MM)

Secondary outcomes

empty

Intervention groups

1

Description
Mouthwash solution of 1% chitosan with a molecular mass of 5000 Dalton, 30 drops as mouth wash for two minutes 4 times per day for 14 days
Category
Treatment - Drugs

2

Description
Control group: rinse solution Nystatin 100,000 UI: 30 drops as mouthwash, 4 times per day for 2 minutes for 14 days.
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Department of Oral Medicine/Kerman Dental School
Full name of responsible person
Dr Negar Salehi
Street address
Kerman Dental Schoo/Shafa av.
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Research center of Kerman Dental School
Full name of responsible person
Dr Zahra Atai
Street address
Department of Oral Medicine of Kerman Dental school/Shafa av.
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Research center of Kerman Dental School
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty

Person responsible for general inquiries

Contact
Name of organization / entity
Kerman Dental School
Full name of responsible person
Negar Salehi
Position
Oral Medicine Resident
Other areas of specialty/work
Street address
Kerman Dental School/Shafa av.
City
Kerman
Postal code
Phone
+98 34 3211 9023
Fax
Email
debonair_n@yahoo.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
Kerman Dental School
Full name of responsible person
Dr Zahra Atai
Position
Associate Professor of Oral Medicine Department
Other areas of specialty/work
Street address
Kerman Dental School/Shafa av.
City
Kerman
Postal code
Phone
+98 34 3211 9023
Fax
Email
z_atai@kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Department of Oral Medicine of Kerman Dental School
Full name of responsible person
Negar Salehi
Position
Oral Medicin Resident
Other areas of specialty/work
Street address
Kerman Dental School/Shafa av.
City
Kerman
Postal code
Phone
+98 34 3211 9023
Fax
Email
debonair.n@yahoo.com
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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