To compare the effect of Clotrimazol gel and Ganoderma gel in symptom reducing and lesion improvement among patients with denture osteomatitis.
Design
Clinical trial with control group, parallel groups, blinded postoperative care and outcome assessment, randomized, on 60 patients. randomization with random numbers table.
Settings and conduct
Research will be accomplished in oral disease section of Isfahan Dental Faculty in 2019-2020 under the observation of a specialist. Double blinding will be applied so that patients and researcher won't realize the type of drug have been given.
Participants/Inclusion and exclusion criteria
Inclusion criteria:Users of acrylic complete removable denture in maxilla who shows signs of type 1 or 2 denture stomatitis.
Non-inclusion criteria: history of Anti fungal, Anti bacterial, Corticosteroid drugs usage in last month.
Intervention groups
Intervention group : will be given 5% Ganoderma gel.
Control group: will be given 1% Clotrimazol gel.
All patients will be asked to do oral and denture hygiene after every meal then clean the tissue side of denture with 12% clorohegzidine and use 5 cm of gel inside denture and put it back inside the mouth.
Main outcome variables
pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20200303046685N2
Registration date:2020-07-06, 1399/04/16
Registration timing:registered_while_recruiting
Last update:2020-07-06, 1399/04/16
Update count:0
Registration date
2020-07-06, 1399/04/16
Registrant information
Name
Fahimeh Pakravan
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 31 3436 8793
Email address
pakravan@dnt.mui.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-06-21, 1399/04/01
Expected recruitment end date
2020-09-22, 1399/07/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparing the antifungal effect of Ganoderma gel and Clotrimazole gel in patients with denture stomatitis
Public title
Evaluation of antifungal effect of Ganoderma in denture stomatitis
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Users of acrylic complete removable denture in maxilla who shows signs of type 1 or 2 denture stomatitis.
Exclusion criteria:
History of Anti fungal, Anti bacterial, Corticosteroid drugs usage in last month
Hypersensitivity to Ganoderma or Clotrimazole
Immune suppression disorders
Alzheimer disease
Neuromuscular disease
Mental disorders and lack of cooperation
Chemotherapy or radiotherapy of head and neck in present or past
Age
No age limit
Gender
Both
Phase
3
Groups that have been masked
Participant
Investigator
Outcome assessor
Sample size
Target sample size:
60
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling method is simple random sampling.
Randomization unit: individual.
Randomization tool: Random number table.
Among patients suffering from Denture stomatitis referred to Isfahan University of Medical Sciences, 60 patients who have been examined and met the eligibility criteria will enter the study and a number will be assigned to every patient. Then they will be divided into two groups using block randomization (block size=30) in the random allocation service software. For allocation concealment, sealed coded boxes with same size and weight will be used.
Blinding (investigator's opinion)
Double blinded
Blinding description
All patients know about drugs used in the research but they don't know which treatment they will be given. The result evaluator clinically observes patients only on follow up sessions. Also the researcher doesn't know about randomization and type of drug each patient have received because the clinical observant is only responsible for drug distribution.
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethics committee of Isfahan University of Medical Sciences
Street address
Department of oral medicine; Faculty of Dentistry; Isfahan University of Medical Sciences; Soffeh boulvard
City
Isfahan
Province
Isfehan
Postal code
8174673461
Approval date
2020-02-23, 1398/12/04
Ethics committee reference number
IR.MUI.RESEARCH.REC.1398.796
Health conditions studied
1
Description of health condition studied
Denture ostomatitis
ICD-10 code
ICD-10 code description
Primary outcomes
1
Description
pain
Timepoint
Before starting research, 7, 14 days afters using drug
Method of measurement
Visual analogue scale
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: patients using 5% Ganoderma 3 times a day by putting 5 cm of gel inside the denture. Mushroom has been bought then it has been extracted by Pharmacognosy section of Isfahan University of Medical Sciences and has been used to produce the gel.
Category
Treatment - Drugs
2
Description
Control group: patients using 1% Clotrimazole 3 times a day by putting 5 cm of gel inside the denture. Powder of Clotrimazole has been bought from Raha company then Pharmaceutics section of Isfahan university of medical science has made the gel.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of oral medicine; Faculty of Dentistry; Isfahan University of Medical Sciences
Full name of responsible person
Fahimeh Pakravan
Street address
Soffeh Boulvard
City
Isfahan
Province
Isfehan
Postal code
8117891389
Phone
+98 31 3792 5515
Email
pakravan@dnt.mui.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Shaghayegh Haghjoo
Street address
Department of oral medicine; Faculty of Dentistry; Isfahan University of Medical Sciences; Soffeh boulvard
City
isfahan
Province
Isfehan
Postal code
8174673461
Phone
+98 31 3436 8793
Email
pakravan@dnt.mui.ac.ir
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Esfahan 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
Esfahan University of Medical Sciences
Full name of responsible person
Fahimeh Pakravan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of oral medicine; Faculty of Dentistry; Isfahan University of Medical Sciences; Soffeh boulvard
City
Isfahan
Province
Isfehan
Postal code
817473461
Phone
+98 31 3436 8793
Email
pakravan@dnt.mui.ac.ir
Person responsible for scientific inquiries
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Fahimeh Pakravan
Position
Assistant professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Department of oral medicine; Faculty of Dentistry; Isfahan University of Medical Sciences; Soffeh boulvard
City
Isfahan
Province
Isfehan
Postal code
817473461
Phone
+98 31 3792 5515
Email
Pakravan@dnt.mui.ac.ir
Person responsible for updating data
Contact
Name of organization / entity
Esfahan University of Medical Sciences
Full name of responsible person
Negin Ghahremani
Position
Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Milad dormitory, Hezarherib Ave
City
Isfahan
Province
Isfehan
Postal code
817473461
Phone
+98 31 3792 5515
Email
ghahremaninegin@gmail.com
Sharing plan
Deidentified Individual Participant Data Set (IPD)
No - There is not a plan to make this available
Justification/reason for indecision/not sharing IPD
Commitment to the principle of confidentiality of the patient’s record
Study Protocol
Yes - There is a plan to make this available
Statistical Analysis Plan
Undecided - It is not yet known if there will be a plan to make this available
Informed Consent Form
No - There is not a plan to make this available
Clinical Study Report
Yes - There is a plan to make this available
Analytic Code
No - There is not a plan to make this available
Data Dictionary
No - There is not a plan to make this available
Title and more details about the data/document
Only information such as main consequence or the like can be shared.
When the data will become available and for how long
Access to the results immediately after publication
To whom data/document is available
Open access
Under which criteria data/document could be used
Access to data is possible only after formal permission from corresponding author
From where data/document is obtainable
Corresponding author
What processes are involved for a request to access data/document