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Effect of injectable mucoadhesive polymeric scaffolds containing aloe vera gel,zinc and mycophenolate mofetil on oral lichen planus lesions

Protocol summary

Study aim
Effect of injectable mucoadhesive polymeric scaffolds containing aloe vera gel,zinc and mycophenolate mofetil on oral lichen planus lesions
Design
Clinical trials, with parallel groups, single-blinded and randomized and sampling method is random. The randomization method is simple and with number Chart. 12 people were selected and one lesion per person was considered as a control and another was considered for treatment. Control lesion, treatment with Adcortyl ointment or Triadent will be used and test lesion will be used the combination of aloe vera extract, zinc and mycophenolate mofetil.
Settings and conduct
The study will be performed in the Oral Medicine Department of Tabriz Dental School. The control lesion will be treated with Aloe vera extract, zinc and mycophenolate mofetil with routine treatment and the test lesion will be treated with routine treatment with Adcortil ointment or Triadent. .
Participants/Inclusion and exclusion criteria
Entrance:Age over 18 years, having lichen planus, willing to participate in the study, Existence of a bilateral lesion Exclusion: Pregnant and lactating women, Systemic use of corticosteroids ,High blood pressure, Smokers ,All items where topical corticosteroids are contraindicated, Adjacent waste with amalgam filling, Systemic diseases
Intervention groups
The combination of three materials of aloe vera extract, zinc and mycophenolate mofetil (MFM) is used as adhesive mucosal scaffolds in oral lichen planus. On the other hand, the same patient is considered as a control group.Routine treatment with Adcortyl ointment or Triadent will be used in both groups.
Main outcome variables
Pain and burning , size of erythema and ulcer

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20200708048057N1
Registration date: 2020-09-04, 1399/06/14
Registration timing: retrospective

Last update: 2020-09-04, 1399/06/14
Update count: 0
Registration date
2020-09-04, 1399/06/14
Registrant information
Name
Zahra Aghazadeh
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 41 3328 6132
Email address
aghazadehz@tbzmed.ac.ir
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2020-01-21, 1398/11/01
Expected recruitment end date
2020-06-20, 1399/03/31
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Effect of injectable mucoadhesive polymeric scaffolds containing aloe vera gel,zinc and mycophenolate mofetil on oral lichen planus lesions
Public title
Effect of Topical Mycophenolate, Zinc and Aloe vera in oral lichen planus ulcers
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Age over 18 years A patient who is diagnosed with lichen planus on pathological examination. Willingness to participate in the study Existence of a bilateral lesion
Exclusion criteria:
Pregnant and lactating women Systemic use of corticosteroids High blood pressure Smokers All items where topical corticosteroids are contraindicated, such as: uncontrolled diabetes, history of tuberculosis, gastric ulcer Adjacent waste with amalgam filling Systemic diseases
Age
From 18 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size: 12
More than 1 sample in each individual
Number of samples in each individual: 2
Lichen planus lesion on one side of the buccal mucosa is considered as the case group and on the other side of the same patient as the control group.
Randomization (investigator's opinion)
Randomized
Randomization description
Sampling method is randomly available among Individuals referring to oral medicine Department of Tabriz Dental faculty. The randomization method is simple . Our tool for randomization is the randomized number chart. Furthermore, the allocation of treatment to patients is done randomly.The lesion of one side of the patient as the control group will receive Adcortil ointment and the other side as the case group will receive scaffold.
Blinding (investigator's opinion)
Not blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features

Secondary Ids

empty

Ethics committees

1

Ethics committee
Name of ethics committee
Ethics committee of Tabriz University of Medical Sciences
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Approval date
2020-07-05, 1399/04/15
Ethics committee reference number
IR.TBZMED.REC.1399.339

Health conditions studied

1

Description of health condition studied
Oral lichen planus
ICD-10 code
l43.8
ICD-10 code description
oral lichen planus

Primary outcomes

1

Description
Size of erythema and ulcer
Timepoint
15 days after treatment
Method of measurement
dental micrometer (colis) .

Secondary outcomes

1

Description
Pain and burning
Timepoint
15 days after receiving the drug
Method of measurement
visual analog scale (VAS)

Intervention groups

1

Description
Intervention group:The case lesion will be covered by scaffolds containing aloe vera extract, zinc and mycophenolate mofetil
Category
Treatment - Drugs

2

Description
Control group: The control lesion will be treated with routine treatment of Adcortyl ointment or Triadent
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Oral Medicine Department, Faculty of Dentistry, Tabriz
Full name of responsible person
Zahra Aghazadeh
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3328 3639
Email
Maghazadehbio@gmail.com

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Prof. Mohammad Samiei
Street address
Floor2, Central Building No.2, Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 7314
Email
Samiei.moh@gmail.com
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tabriz 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
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Aghazadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3328 3639
Email
Maghazadehbio@gmail.com

Person responsible for scientific inquiries

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Ali Taghavi
Position
Associated Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3335 5965
Email
taghaviz_a@hotmail.com

Person responsible for updating data

Contact
Name of organization / entity
Tabriz University of Medical Sciences
Full name of responsible person
Zahra Aghazadeh
Position
Assistant Professor
Latest degree
Specialist
Other areas of specialty/work
Dentistry
Street address
Tabriz University of Medical Sciences, Golgasht St.
City
Tabriz
Province
East Azarbaijan
Postal code
5166614711
Phone
+98 41 3328 3639
Email
Maghazadehbio@gmail.com

Sharing plan

Deidentified Individual Participant Data Set (IPD)
Undecided - It is not yet known if there will be a plan to make this available
Study Protocol
Undecided - It is not yet known if there will be 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
Undecided - It is not yet known if there will be a plan to make this available
Clinical Study Report
Undecided - It is not yet known if there will be a plan to make this available
Analytic Code
Undecided - It is not yet known if there will be a plan to make this available
Data Dictionary
Undecided - It is not yet known if there will be a plan to make this available
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