PRF in Management of Chronic Multiple Oral Ulcers
Primary Purpose
Oral Ulcer Due to Pemphius Vularis, Oral Ulcer Due to Benign Mucous Membrane Pemphioid, Oral Ulcer Due to Steven Johnson's Syndrome
Status
Completed
Phase
Phase 1
Locations
Egypt
Study Type
Interventional
Intervention
Platelet rich fibrin gel in Orabase
Dermovate cream in Orabase
Sponsored by
About this trial
This is an interventional treatment trial for Oral Ulcer Due to Pemphius Vularis focused on measuring Platelet rich fibrin, Oral Ulcer, Pain, Mucositis
Eligibility Criteria
Inclusion Criteria:
- Patients with Oral ulcers due to Benin mucous membrane pemphioid, Pemphius vulgaris and Steven Johnson's Syndrome with mucositis score 4 and pain score 10
Exclusion Criteria:
- patients with any systemic other systemic condition
Sites / Locations
- Eman Ahmed
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
autologous Platelet rich fibrin in Orabase (PRF)
Clobetasol propionate 0.05%(Dermovate cream) in orabase
Arm Description
applied to oral ulcer and/or mucositis 3 times per day
applied to oral ulcer and/or mucositis 3 times per day
Outcomes
Primary Outcome Measures
Pain score
Numerical Rating score of Pain, graded from 0 to 10, were 0 is no pain at all and 10 represent severe pain, obtaining lower values reflects improvement
Secondary Outcome Measures
Mucositis
WHO mucositis score, graded from 0 to 4 were 0 no mucositis and 4 severe mucositis, obtaining lower values reflects improvement
ulcer size
Measurement in cm for the largest ulcer, expressed as maximum height x maximum width reflecting the average size, decrease in size is improvement
ulcer number
number counted for each patient, decrease in number reflects improvement
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03878771
Brief Title
PRF in Management of Chronic Multiple Oral Ulcers
Official Title
Platelet Rich-plasma in Management of Chronic Multiple Oral Ulcers
Study Type
Interventional
2. Study Status
Record Verification Date
September 2020
Overall Recruitment Status
Completed
Study Start Date
March 13, 2019 (Actual)
Primary Completion Date
April 15, 2019 (Actual)
Study Completion Date
April 15, 2019 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Beni-Suef 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
PRF in orabase will be applied as a pack material on chronic oral ulcers of chronic multiple oral lesions compared to conventional topical steroid therapy with clobetasol propionate 0.05% in orabase. The outcomes measured are Pain alleviation as Primary outcome and Clinical improvement in terms of Ulcer size, Number and Mucositis score as Secondary outcomes. Time frame for outcomes assessment will be Daily for 7 Days regarding pain score and weekly for 2 weeks regarding clinical improvement.
Detailed Description
The management of oral ulcers and mucositis specially the resistant types such as oral ulcers due to auto-immune diseases is a major concern by the dentists through all the world. Topical corticosteroids, analgesics, Laser bio modulation all have been proposed as treatments with limited efficacy in many cases. There are few number of clinical trials on Plasma preparation in management of oral mucositis and oral ulcers. Platelet rich fibrin (PRF) is one of the platelet concentrates. The preparation protocol of PRF is simple and easy, could be prepared autologous and immediately placed on the oral ulcers and mucositis.
Subjects and Methods: A non Randomized clinical trial will be conducted. Ten patients with different resistant oral ulcers and mucositis were enrolled. all with grade 4 WHO mucositis score. The initial numerical ratting score of pain is 10. For all patients 20 ml blood sample will obtained in plain blood vacutainer, centrifuged for 15 minutes on 3000 rpm. The resultant gel, obtained and squeezed to prepare a membrane, the membrane will be mixed with orabase and placed over the oral ulcers and mucositis over a piece of gauze. The patients will be instructed not to eat or drink for 2 hours after application. The remaining serum after squeezing was mixed with equal amount of orabase and used topically on the oral mucositis and ulcers.
Clobetasol Propionate 0.05% in orabase will be applied to 10 control patients 3 times per day for one week.
The steps will be repeated after one week if the patients' symptomatic scores for WHO and numerical rating score were not zero.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Oral Ulcer Due to Pemphius Vularis, Oral Ulcer Due to Benign Mucous Membrane Pemphioid, Oral Ulcer Due to Steven Johnson's Syndrome
Keywords
Platelet rich fibrin, Oral Ulcer, Pain, Mucositis
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Parallel Assignment
Model Description
Patients with chronic multiple oral lesions due to benign mucous membrane Pemphigoid, Pemphigus vulgaris, ans Steven Johnson's Syndrome
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
804 (Actual)
8. Arms, Groups, and Interventions
Arm Title
autologous Platelet rich fibrin in Orabase (PRF)
Arm Type
Experimental
Arm Description
applied to oral ulcer and/or mucositis 3 times per day
Arm Title
Clobetasol propionate 0.05%(Dermovate cream) in orabase
Arm Type
Active Comparator
Arm Description
applied to oral ulcer and/or mucositis 3 times per day
Intervention Type
Biological
Intervention Name(s)
Platelet rich fibrin gel in Orabase
Other Intervention Name(s)
autologus PRF gel
Intervention Description
applied on oral mucositis and /or ulcer 3 times per day
Intervention Type
Drug
Intervention Name(s)
Dermovate cream in Orabase
Other Intervention Name(s)
Clobetasol Propionate 0.05%
Intervention Description
applied on oral mucositis and /or ulcer 3 times per day
Primary Outcome Measure Information:
Title
Pain score
Description
Numerical Rating score of Pain, graded from 0 to 10, were 0 is no pain at all and 10 represent severe pain, obtaining lower values reflects improvement
Time Frame
1 week
Secondary Outcome Measure Information:
Title
Mucositis
Description
WHO mucositis score, graded from 0 to 4 were 0 no mucositis and 4 severe mucositis, obtaining lower values reflects improvement
Time Frame
2 weeks
Title
ulcer size
Description
Measurement in cm for the largest ulcer, expressed as maximum height x maximum width reflecting the average size, decrease in size is improvement
Time Frame
2 weeks
Title
ulcer number
Description
number counted for each patient, decrease in number reflects improvement
Time Frame
2 weeks
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Patients with Oral ulcers due to Benin mucous membrane pemphioid, Pemphius vulgaris and Steven Johnson's Syndrome with mucositis score 4 and pain score 10
Exclusion Criteria:
patients with any systemic other systemic condition
Facility Information:
Facility Name
Eman Ahmed
City
Beni-Suef
State/Province
Beni Suef
ZIP/Postal Code
1178
Country
Egypt
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Time Frame
a
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PRF in Management of Chronic Multiple Oral Ulcers
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