Evaluation of the lesion size and candida colony count before and after photodynamic therapy and treatment with nystatin and comparing them.
Design
This is a parallel, double blind randomized clinical trial (phase 2) with control group on twenty four patients in each group who will be enrolled randomly by block randomization.
Settings and conduct
Participants with denture stomatitis attending at Shiraz University of Dental School will be enrolled in this study.
In intervention group nystatin therapy and photodynamic therapy will be considered. In control group just nystatin therapy will be prescribed. Their effect will be compared.
Since patients do not know the on or off mode of laser and also the outcome assessor will not know type of treatment, both will be blind.
Participants/Inclusion and exclusion criteria
Inclusion criteria : patient with denture stomatitis
exclusion criteria: diabetic patient, patient who used antibiotic or anti fungal or corticosteroids within last 3 months, immune suppressed patients.
Intervention groups
Intervention group: Patient with denture stomatitis will be treated by nystatin solution (Jaber-ebn-Haian company, Tehran, Iran). Lesion will be applied by indocyanin green (Ench industry company, Shandong, China). A diode laser (A.R.C. laser GmbH, Nurnberg, Germany) with wavelength of 810 nm with 300 mW, continuous mode, 30 seconds and resultant energy density of 55J/cm2 and spot size of 4.5mm will be used for activation of this dye. Photodynamic therapy will be done in day 1 and day 15.
Control group: Patient with denture stomatitis will be treated by nystatin solution. Lesion will be applied by indocyanin green. Sham laser will be used.
Main outcome variables
lesion size, colony count
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120101008585N6
Registration date:2018-12-26, 1397/10/05
Registration timing:registered_while_recruiting
Last update:2018-12-26, 1397/10/05
Update count:0
Registration date
2018-12-26, 1397/10/05
Registrant information
Name
Fatemeh Lavaee
Name of organization / entity
Shiraz Dental School
Country
Iran (Islamic Republic of)
Phone
+98 71 1631 9309
Email address
lavaeef@sums.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2018-08-02, 1397/05/11
Expected recruitment end date
2019-08-02, 1398/05/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of Indocyanine green mediated photodynamic therapy on grade and size of Denture stomatitis
Public title
Effect of indocyanin green on denture stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Edentulous denture-wearing patients with denture stomatitis
Exclusion criteria:
Immunosuppressive patient
Diabetic patient
Patient who used antibiotic, antifungal medication or corticosteroid during last 3 months
Chemotherapy or radiotherapy
Age
From 20 years old
Gender
Both
Phase
2-3
Groups that have been masked
Participant
Outcome assessor
Sample size
Target sample size:
48
Randomization (investigator's opinion)
Randomized
Randomization description
Each block with 4 allocations, consisting 2 allocation for intervention and 2 for control group will be considered. Six possible sequence of treatment allocation in each block will be listed and each one will be written on a card. Each time a block will be selected and the sequence of treatment will be registered until the treatment allocations become completed for all 48 participants (12 blocks).
The randomization was performed by a methodologist. Allocation concealment will be done by the main researcher. On each 48 cards a sequence will be written and sealed. Pockets will be put in a box. A pocket will be allocated for each participant based on order of enrollment.
Blinding (investigator's opinion)
Double blinded
Blinding description
Participant will be blind to their treatment. Nystatin oral suspension will be prescribed in both groups. In the intervention group photodynamic therapy will be done at the same period.In the control group sham laser will be irradiated. Since patients do not know the on or off mode of applied laser and also since the assessor of parameters is different from the one who will apply laser, both participants in intervention group and the assessor will be blind.
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Shiraz University of Medical Sciences
Street address
Shiraz University of Medical Sciences, Namazi square, Zand street, Shiraz, Iran
City
Shiraz
Province
Fars
Postal code
7186781559
Approval date
2018-07-29, 1397/05/07
Ethics committee reference number
ir.sums.rec.1397.411
Health conditions studied
1
Description of health condition studied
Denture stomatitis
ICD-10 code
B37.0
ICD-10 code description
Candidal stomatitis
Primary outcomes
1
Description
Lesion size
Timepoint
Day 1 and 15
Method of measurement
Newton's classification
2
Description
candida colony count
Timepoint
Day 1 and 15
Method of measurement
CFU/ml colony count
Secondary outcomes
1
Description
Indocyanine green hypersensivity
Timepoint
Day 1 and 15
Method of measurement
clinical symptom of hypersensitivity
Intervention groups
1
Description
Intervention group: Nystatin oral suspension (100 000 U manufactured by Jaber-ebn-Haian) will be prescribed to swish it for 4 min, gargle, and then expectorate it three times daily for 15 days. Photodynamic therapy will be applied on denture stomatitis lesions in day 1 and 15. Topical indocyanin green (Ench industry company, Shandong, China) will be applied with micropipette on lesion and after 10 min, the lesion will be irradiated with a 810nm diode laser for 30sec (power: 300mW).
Category
Treatment - Other
2
Description
Control group: nystatin oral suspension (100 000 U manufactured by Jaber-ebn-Haian company) will be prescribe to swish it for 4 min, gargle, and then expectorate it three times daily for 15 days. Topical indocyanin green (Ench industry company, Shandong, China) with micro pipette and sham laser irradiation will done in day 1 and 15.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
School of Dentistry, Shiraz University of Medical Sciences
Full name of responsible person
Dr.Fateme Lavaee
Street address
Shiraz Dental School, Ghasrdasht street, Shiraz
City
Shiraz
Province
Fars
Postal code
7186781559
Phone
+98 71 3628 0456
Fax
+98 71 3626 3193
Email
dental@sums.ac.ir
Web page address
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr. Basir Hashemi
Street address
Shiraz university of Medical Sciences, Zand street, Iran
City
Shiraz
Province
Fars
Postal code
7186782559
Phone
+98 71 3212 2438
Email
hashemib@sums.ac.ir
Web page address
Grant name
Grant code / Reference number
95-01-03-11515
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Shiraz University of Medical Sciences
Proportion provided by this source
100
Public or private sector
Public
Domestic or foreign origin
Domestic
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
Academic
Person responsible for general inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Assistant Professor of Oral and Maxillofacial Medicine Department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
City
shiraz
Province
Fars
Postal code
7186781559
Phone
+98 71 3631 9309
Email
lavaeef@sums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Assistant Professor of Oral and Maxillofacial Medicine Department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
City
shiraz
Province
Fars
Postal code
7186781559
Phone
+98 71 3631 9309
Email
lavaeef@sums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fatemeh Lavaee
Position
Assistant Professor of Oral and Maxillofacial Medicine Department
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Shiraz School of Dentistry, Ghasrdasht street, Shiraz, Iran
City
shiraz
Province
Fars
Postal code
7186781559
Phone
+98 71 3631 9309
Email
lavaeef@sums.ac.ir
Sharing plan
Deidentified Individual Participant Data Set (IPD)
Yes - There is a plan to make this available
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Yes - There is a plan to make this available
Informed Consent Form
Yes - There is a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
Yes - There is a plan to make this available
Data Dictionary
Yes - There is a plan to make this available
Title and more details about the data/document
All collected data will be shared after deidentification of participants.
When the data will become available and for how long
6 months after publication data will become available.
To whom data/document is available
The researchers in academic institutions.
Under which criteria data/document could be used
The researchers in academic institutions.
From where data/document is obtainable
The researchers in academic institutions can email responsible person and request information.
What processes are involved for a request to access data/document
The researchers in academic institutions can email responsible person and request information.