The aim of this study is preparing mucoadhesive form of dexamethasone and evaluation of its efficacy
Design
Clinical trial phase 2-3 with control group, with parallel groups, randomised trial with blinded outcome assessment
Settings and conduct
This study will be done on patients with oral lichen planus lesions who will be referred to Oral and Maxillofacial Disease Department of Shiraz Dental School. In one group, the dexamethasone mucoadhesive and triadent will be prescribed for the other group. The assessor of outcomes will be blinded to the type of prescribed medication.
Participants/Inclusion and exclusion criteria
Inclusion criteria:
The patients with atrophic or erosive oral lichen planus
The patients with histopathology and clinically conformed lichen planus
The patients who will be referred to Oral and Maxillofacial Disease Department of Shiraz Dental School
Exclusion criteria:
The patients with history of other inflammatory diseases
The patients with history of malignancies or even dysplastic lesions
The patients who have received treatment for oral lichen planus lesions since a previous month
pregnant women
Intervention groups
Intervention group: The patient in intervention group will receive new designed dexamethasone mucoadhesive. This mucoadhesive will be used topically two times a day for 2 weeks and the next 2 weeks they will use the mucoadhesive once a day. The ointment will be retained for 5 minutes and then spitting.
Control group: In this group patients will receive triadent 0.1% Razi company , 2 times a day for 2 weeks and the next 2 weeks they will use the mucoadhesive once a day. The ointment will be retained for 5 minutes and then spitting.
Main outcome variables
Pain, size
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20120101008585N7
Registration date:2019-01-11, 1397/10/21
Registration timing:registered_while_recruiting
Last update:2019-01-11, 1397/10/21
Update count:0
Registration date
2019-01-11, 1397/10/21
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
2018-12-31, 1397/10/10
Expected recruitment end date
2019-08-23, 1398/06/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparision the effect of dexamethasone mucoadhesive and triadent on the size and pain of oral lichen planus lesions
Public title
Evaluation the effect of dexamethasone mucoadhesive on oral lichen planus lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
The patients with atrophic or erosive oral lichen planus
The patients with histopathology and clinically conformed lichen planus
The patients who will be referred to Oral and Maxillofacial Disease Department of Shiraz Dental School
Exclusion criteria:
The patients with history of other inflammatory diseases
The patients with history of malignancies or even dysplastic lesions
The patients who have received treatment for oral lichen planus lesions since a previous month
pregnant women
Age
From 18 years old
Gender
Both
Phase
2-3
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
30
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 30 participants (8 blocks).
The randomization was performed by a methodologist. Allocation concealment will be done by the main researcher. On each 30 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)
Single blinded
Blinding description
The outcome assessor will be blinded to the type of prescribed medication.
Placebo
Not 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
2018-12-25, 1397/10/04
Ethics committee reference number
IR.SUMS.REC.1397.925
Health conditions studied
1
Description of health condition studied
Lichen planus
ICD-10 code
L43
ICD-10 code description
Lichen planus
Primary outcomes
1
Description
Pain
Timepoint
Week 1,2,4
Method of measurement
Visual analogue scale
2
Description
Size
Timepoint
Week 1,2,4
Method of measurement
Scaled tongue blade(mm)
3
Description
Clinical presentation or inflammation
Timepoint
Week 1,2,4
Method of measurement
Thongprasom sign scoring
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: The patient in intervention group will receive new designed dexamethasone mucoadhesive. This mucoadhesive will be used topically two times a day for 2 weeks and the next 2 weeks they will use the mucoadhesive once a day. The ointment will be retained for 5 minutes and then spitting. After breakfast and dinner mucoadhesive will be prescribed and the participants should refuse eating and drinking up to 30 minutes after application of Dexamethasone.
Category
Treatment - Drugs
2
Description
Control group: In this group patients will receive triadent 0.1% Razi company , 2 times a day for 2 weeks and the next 2 weeks they will use the mucoadhesive once a day. The ointment will be retained for 5 minutes and then spitting. After breakfast and dinner mucoadhesive will be prescribed and the participants should refuse eating and drinking up to 30 minutes after application of Triadent.
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
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 3626 3193
Email
lavaeef@sums.ac.ir
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr.Ghhasemi
Street address
Shiraz university of Medical Sciences, Zand street, Iran
City
Shiraz
Province
Fars
Postal code
7186782559
Phone
+98 71 3212 2438
Email
ghasemim@summs.ac.ir
Grant name
Grant code / Reference number
97-01-99-17149
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
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
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 3626 3193
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.