In the human model, we will investigate the effect of gel containing silver nanoparticles and triamistolone ointment on the healing of lichen planus lesions in the human model.
Design
Clinical trial with control group, with parallel groups, single-blind, phase 1-2 on 40 patients. Randomization will be done by simple randomization using a sealed envelope containing one bead (white bead of the intervention group, red bead of the control group).
Settings and conduct
Patients with oral lichen planus are divided into two groups (intervention and control) by random block allocation method in the diagnosis department of the dental school. Gel containing silver nanoparticles will be prescribed for the intervention group and topical corticosteroid ointment 0.1% (triamcinolone) will be prescribed for the control group. The rate of improvement of the patients and the intensity of pain will be monitored at intervals of 2, 4 and 8 weeks after the start of the treatment. The study will be single blind. The outcome assessor is blinded to the placement of patients in the intervention and control groups.
Participants/Inclusion and exclusion criteria
Inclusion criteria - patients with definite diagnosis of lichen planus using clinical method and pathological sampling of erosive/atrophic lichen planus type, absence of dysplasia and patient's satisfaction.
Exclusion criteria are pregnant women, injuries in contact with amalgam, use of drugs that cause lycanoid reactions, any treatment that has been done for these injuries, use of immunosuppressive drugs, history of sensitivity to silver.
Intervention groups
A gel containing silver nanoparticles will be prescribed for one group, and topical corticosteroid ointment 0.1% (triamcinolone) will be prescribed for the other group.
Main outcome variables
The rate of improvement of patients and the intensity of pain
General information
Reason for update
Acronym
IRCT registration information
IRCT registration number:IRCT20230823059242N1
Registration date:2024-06-03, 1403/03/14
Registration timing:retrospective
Last update:2024-06-03, 1403/03/14
Update count:0
Registration date
2024-06-03, 1403/03/14
Registrant information
Name
Fatemeh Beheshti
Name of organization / entity
Country
Iran (Islamic Republic of)
Phone
+98 71 3626 3193
Email address
fatemebeheshticync@gmail.com
Recruitment status
Recruitment complete
Funding source
Expected recruitment start date
2023-09-23, 1402/07/01
Expected recruitment end date
2023-11-22, 1402/09/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Comparison between of the effect triamcinolone oral paste and silver nanoparticles gel on the lichen planus lesions healing in human model
Public title
The effect of gel containing silver nanoparticles and triamcinolone ointment on the healing of lichen planus lesions
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria:
Definitive diagnosis of lichen planus using clinical method and pathological tissue sampling
Type of erosive/atrophic lichen planus
Absence of dysplasia
Exclusion criteria:
Pregnant women
Injuries in contact with amalgam
The use of drugs that cause lycanoid reactions
Any treatment that has been done for these injuries
Use of immunosuppressive drugs
A history of sensitivity to silver and the presence of any systemic disease
Age
No age limit
Gender
Both
Phase
1-2
Groups that have been masked
Outcome assessor
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Randomization will be done by random block method and using blocks of 4. In this way, first, 60 different quadruple blocks are created (ABBA, BABA, ABAB, BBAA, AABB and BABA), and one of these blocks is randomly selected.
According to the order mentioned in the selected block, the patients will be divided into one of two groups A or B. Then randomization is done for other patients as well.
Blinding (investigator's opinion)
Single blinded
Blinding description
The outcome assessor is not aware of the placement of the patient in the intervention and control groups
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
Zand St., Central Building of Shiraz University of Medical Sciences
City
Shiraz
Province
Fars
Postal code
7134814336
Approval date
2023-12-20, 1402/09/29
Ethics committee reference number
IR.SUMS.DENTAL.REC.1402.096
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
Recovery rate
Timepoint
At intervals of 2, 4 and 8 weeks after the intervention
Method of measurement
It will be evaluated based on the classification and criteria of Tangprasum. The classification of the clinical criteria of Tangprasum is as follows: 0) harmless 1) mild white lines without inflammatory areas 2) white lines with atrophic areas smaller than one square centimeter 3) white lines with atrophic areas larger than one square centimeter 4 (white lines with erosive areas smaller than one square centimeter 5) white lines with erosive areas larger than one square centimeter or with ulcerative lesions
2
Description
Pain
Timepoint
At intervals of 2, 4 and 8 weeks after the intervention
Method of measurement
Postoperative pain will be evaluated using a visual analog scale (VAS), with 10 ratings, from 0 for "no pain" to 10 for "worst possible pain".
Secondary outcomes
empty
Intervention groups
1
Description
Intervention group: gel containing silver nanoparticles (Made By US-NANO), some gel is placed on the affected area three times a day after meals for 5 minutes. The treatment is done for two months
Category
Treatment - Drugs
2
Description
Control group: 0.1% topical corticosteroid ointment (triamcinolone, Iran Najo Pharmaceuticals), three times a day after meals, some gel is placed on the affected area for 5 minutes. The treatment lasts for two months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Department of Diagnosis and Oral Diseases, School of Dentistry, Shiraz University of Medical Science
Full name of responsible person
Fatima Beheshti
Street address
Qomabad St. Qasrdasht - School of Dentistry
City
shiraz
Province
Fars
Postal code
1587871956
Phone
+98 71 3628 0112
Email
fatemebeheshticync@gmail.com
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Dr Mohammad hashem Hashempour
Street address
Zand St
City
Shiraz
Province
Fars
Postal code
7134814336
Phone
+98 71 3235 7282
Email
hashempurm@sums.ac.ir
Grant name
Grant code / Reference number
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
Fateme Beheshti
Position
Dental Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Qomabad St
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
fatemebeheshticync@gmail.com
Person responsible for scientific inquiries
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fateme Beheshti
Position
Dental Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Qomabad St
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
fatemebeheshticync@gmail.com
Person responsible for updating data
Contact
Name of organization / entity
Shiraz University of Medical Sciences
Full name of responsible person
Fateme Beheshti
Position
Dental Student
Latest degree
A Level or less
Other areas of specialty/work
Dentistry
Street address
Qomabad St
City
Shiraz
Province
Fars
Postal code
7195615878
Phone
+98 71 3626 3193
Email
fatemebeheshticync@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