Efficacy of Intralesional Injection of Platelet Rich Plasma in the Treatment of Patients With Erosive Oral Lichen Planus
Primary Purpose
Erosive Oral Lichen Planus
Status
Completed
Phase
Phase 2
Locations
Egypt
Study Type
Interventional
Intervention
Platelet rich plasma
Triamcinolone Acetonide
Sponsored by
About this trial
This is an interventional treatment trial for Erosive Oral Lichen Planus focused on measuring Oral, Lichen planus, PRP
Eligibility Criteria
Inclusion Criteria:
- Patients presenting with a clinical picture that assumes the diagnosis of erosive oral lichen planus (bilateral, more or less symmetrical erosive lesions with lacelike network of slightly raised gray white lesions (reticular pattern), and a histological findings that confirms the diagnosis (liquefaction degeneration of the basal cell layer with irregular-saw teeth like rete pegs.
Exclusion Criteria:
- Systemic disorders such as hematological diseases, severe cardiovascular diseases, treatment with any drugs that could cause Lichenoid reaction.
- Pregnancy or active breastfeeding
- Patients who had lesion/lesions with dysplasia
- Patients who received topical treatment for Oral Lichen planus in the last 2 weeks (Lee et al., 2013) or systemic treatment for OLP in the past 3 months.
- Platelet count < 150,000/mm3; Hgb < 11 g/dl.
- Immunosuppressed patients
- Patients receiving therapy with anticoagulants and use of non-steroidal anti-inflammatory drugs in the 5 days before taking the blood sample.
Sites / Locations
- Faculty of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Platelet rich plasma
Croticosteroids
Arm Description
0.5 ml of autologous platelet rich plasma prepared using a double spin technique described by Mostafa et al., 2013 will be injected in the center of eroded oral mucosa in patients suffering from oral lichen planus.
0.5 ml of triamcinolone acetonide 40 mg will be injected in the center of eroded oral mucosa in patients suffering from oral lichen planus.
Outcomes
Primary Outcome Measures
Reported Pain
Pain and burning sensation assessed using Numerical rating scale
Secondary Outcome Measures
Clinical score
Clinical score using a 5 grades scoring system described by Thongprasom et al.,1992
Remission time
Time until flare up of the disease occur using a binary scale (Stable/Not stable) described by Conrotto et al., 2006
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03293368
Brief Title
Efficacy of Intralesional Injection of Platelet Rich Plasma in the Treatment of Patients With Erosive Oral Lichen Planus
Official Title
Efficacy of Intralesional Injection of Autologous Platelet Rich Plasma Versus Intralesional Injection of Corticosteroids on Pain Relief and Ulcers Healing in Patients With Erosive Oral Lichen Planus; Randomized Clinical Trial
Study Type
Interventional
2. Study Status
Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
January 1, 2018 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
January 1, 2021 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Cairo University
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
Brief Summary
After signing the informed consent, the participant will be allocated to either intervention or control group, then each participant in the intervention group will receive intralesional injections of platelet rich plasma extracted from their own blood in each visit as following:
12 ml of blood will be assembled from the veins of antecubital fossa
PRP preparation will be done according to Mostafa et al., 2013
0.5 ml of PRP will be injected per 1 cm2 of ulcerated mucosa
The second group will receive triamcinolone acetonide 40 mg injected 1 ml per 1 cm2 of ulcerated mucosa
Both groups will receive a total of 4 injection, the injections will be carried out once a week.
Pain, lesions size and remission time are the outcomes will be assessed using a numerical rating scale (Seymour, 1982), clinical score according to Thongprasom et al., 1992 and binary scale for remission time according to Conrotto et al., 2006, respectively.
Assessment of the outcomes will be carried before the trial (baseline records) and before receiving the treatment in each visit by the primary investigator (H.A.) and the blinded assessor (Dr. A.W.) separately.
Each participant will have a total of 11 visits during the trial, 5 visits will be once every week during the trial and every 2 weeks for 3 months treatment free.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Erosive Oral Lichen Planus
Keywords
Oral, Lichen planus, PRP
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
20 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Platelet rich plasma
Arm Type
Experimental
Arm Description
0.5 ml of autologous platelet rich plasma prepared using a double spin technique described by Mostafa et al., 2013 will be injected in the center of eroded oral mucosa in patients suffering from oral lichen planus.
Arm Title
Croticosteroids
Arm Type
Active Comparator
Arm Description
0.5 ml of triamcinolone acetonide 40 mg will be injected in the center of eroded oral mucosa in patients suffering from oral lichen planus.
Intervention Type
Biological
Intervention Name(s)
Platelet rich plasma
Other Intervention Name(s)
Platelet rich in growth factors
Intervention Description
Platelet rich plasma will be prepared from the patients own blood in the same visit using a double spin technique, then 0.5 ml of PRP will be injected per 1 cm2 of eroded oral mucosa.
Intervention Type
Drug
Intervention Name(s)
Triamcinolone Acetonide
Other Intervention Name(s)
Corticosteroids, Steroids
Intervention Description
0.5 ml of triamcinolone acetonide 40mg will be injected per 1 cm2 of eroded oral mucosa
Primary Outcome Measure Information:
Title
Reported Pain
Description
Pain and burning sensation assessed using Numerical rating scale
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Clinical score
Description
Clinical score using a 5 grades scoring system described by Thongprasom et al.,1992
Time Frame
3 months
Title
Remission time
Description
Time until flare up of the disease occur using a binary scale (Stable/Not stable) described by Conrotto et al., 2006
Time Frame
3 months
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients presenting with a clinical picture that assumes the diagnosis of erosive oral lichen planus (bilateral, more or less symmetrical erosive lesions with lacelike network of slightly raised gray white lesions (reticular pattern), and a histological findings that confirms the diagnosis (liquefaction degeneration of the basal cell layer with irregular-saw teeth like rete pegs.
Exclusion Criteria:
Systemic disorders such as hematological diseases, severe cardiovascular diseases, treatment with any drugs that could cause Lichenoid reaction.
Pregnancy or active breastfeeding
Patients who had lesion/lesions with dysplasia
Patients who received topical treatment for Oral Lichen planus in the last 2 weeks (Lee et al., 2013) or systemic treatment for OLP in the past 3 months.
Platelet count < 150,000/mm3; Hgb < 11 g/dl.
Immunosuppressed patients
Patients receiving therapy with anticoagulants and use of non-steroidal anti-inflammatory drugs in the 5 days before taking the blood sample.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Soheir Gaafar, Professor
Organizational Affiliation
Professor of oral medicine, diagnosis and periodontology. Faculty of Dentistry. Cairo University
Official's Role
Study Chair
Facility Information:
Facility Name
Faculty of Dentistry
City
Cairo
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Undecided
Citations:
PubMed Identifier
35218680
Citation
Hijazi A, Ahmed W, Gaafar S. Efficacy of intralesional injections of platelet-rich plasma in patients with oral lichen planus: A pilot randomized clinical trial. Clin Exp Dent Res. 2022 Jun;8(3):707-714. doi: 10.1002/cre2.550. Epub 2022 Feb 26.
Results Reference
derived
Learn more about this trial
Efficacy of Intralesional Injection of Platelet Rich Plasma in the Treatment of Patients With Erosive Oral Lichen Planus
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