1. Home
  2. Approved trials
  3. » فارسی

The effect of platelet-rich plasma on pain and size of oral lichen planus

Protocol summary

Study aim
- Determination the effect of platelet-rich plasma injections and triadent oral paste on the VAS and Thongpressam scale of patients with oral lichen planus on day 0, 7,14, 30, 60
Design
Clinical trial phase 1-2 with control group, with parallel groups, randomized trial with double blinded outcome assessment on 15 patients. block randomization will be used.
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 side of intervention group, the paltelet rich plasma and triadent will be prescribed and for control side just triadent. The assessor of outcomes and statistical analysor will be blinded to the type of prescribed medication.
Participants/Inclusion and exclusion criteria
Inclusion: The patients with histopathology and clinically conformed atrophic or erosive oral lichen planus Exclusion: The patients with history of other inflammatory diseases, malignancies or even dysplastic lesions
Intervention groups
Intervention group: The prepared PRP will be injected around the lesion and intra lesion with anesthesia by insulin syringe twice (once every week) during first two weeks beside twice in a day use of triadent oral paste 0.1% (Raha Pharmaceutical company- Iran) .The VAS and thongpressom scale will assed the pain, size (days 0, 7, 14, 30, 60). Control group: The patient with two-sided OLP will be under routine treatment during the study. Both sides OLP lesions will be treated by triadent oral paste 0.1% (Raha Pharmaceutical company- Iran) twice in a day. The lesion on control side will only receive triadent. The VAS and thongpressom scale will assed the pain, size on days 0, 7, 14, 30, 60.
Main outcome variables
Pain, size

General information

Reason for update
Acronym
IRCT registration information
IRCT registration number: IRCT20120101008585N10
Registration date: 2021-11-10, 1400/08/19
Registration timing: prospective

Last update: 2021-11-10, 1400/08/19
Update count: 0
Registration date
2021-11-10, 1400/08/19
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
2021-12-21, 1400/09/30
Expected recruitment end date
2022-10-22, 1401/07/30
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of platelet-rich plasma on pain and size of oral lichen planus
Public title
The effect of platelet-rich plasma on oral lichen planus
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 pregnant women The patients with history of malignancies or even dysplastic lesionsThe patients who have received treatment for oral lichen planus lesions since a previous month pregnant women
Age
From 18 years old
Gender
Both
Phase
1-2
Groups that have been masked
  • Outcome assessor
  • Data analyser
Sample size
Target sample size: 15
More than 1 sample in each individual
Number of samples in each individual: 2
The patients with two-sided atrophic or erosive oral lichen planus, two different intervention will be done on lesions of each side
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)
Double blinded
Blinding description
The outcome assessor, patient and data analyzer 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
2020-09-02, 1399/06/12
Ethics committee reference number
IR.SUMS.REC.1399.734

Health conditions studied

1

Description of health condition studied
Oral lichen planus
ICD-10 code
L43
ICD-10 code description
Lichen planus

Primary outcomes

1

Description
Pain
Timepoint
Days 0, 14, 30, 60
Method of measurement
Visual analogue scale

2

Description
Size
Timepoint
Days 0, 14, 30, 60
Method of measurement
Scaled tongue blade(mm)

Secondary outcomes

empty

Intervention groups

1

Description
Intervention group: The prepared PRP will be injected around the lesion and intra lesion with anesthesia by insulin syringe. The injections will be performed twice (once every week) during first two weeks (days 0, 7, 14, 30, 60). Follow up sessions are weekly until the end of the second month (days 0, 7, 14, 30, 60). The VAS and thongpressom scale will assed the pain, size. The patient with two-sided OLP will be under routine treatment during the study. Both sides OLP lesions will be treated by triadent oral paste 0.1% (Raha Pharmaceutical company- Iran) twice in a day. The lesion on intervention side will receive PRP in addition to triadent. All participants will also be prescribed for 40 drops of Nystatin oral drop 100000U (Emad Darman Pars- Iran) twice in a day.
Category
Treatment - Drugs

2

Description
Control group: The patient with two-sided OLP will be under routine treatment during the study. Both sides OLP lesions will be treated by triadent oral paste 0.1% (Raha Pharmaceutical company- Iran) twice in a day. The lesion on control side will only receive triadent. All participants will also be prescribed for 40 drops of Nystatin oral drop 100000U (Emad Darman Pars- Iran) twice in a day.The VAS and thongpressom scale will assed the pain, size on days 0, 7, 14, 30, 60.
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
Fatemeh 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
Abbas Rezaianzadeh
Street address
Shiraz university of Medical Sciences, Zand street, Iran
City
Shiraz
Province
Fars
Postal code
7186782559
Phone
+98 71 3212 2438
Email
rezaeianzadeha@sums.ac.ir
Grant name
Grant code / Reference number
98-01-21-21242
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
Iran University of Medical Sciences
Full name of responsible person
Shiraz University of Medical Sciences
Position
Associate professor
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
Associate professor
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
Associate professor
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
Comments
Loading...