PRF in Management of Chronic Multiple Oral Ulcers

Oral Ulcer Due to Benign Mucous Membrane Pemphioid Clinical Trial

Official title:

Platelet Rich-plasma in Management of Chronic Multiple Oral Ulcers

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03878771
• Other study ID #: 00uad
• Status: Completed
• Phase: Phase 1
• Start date: March 13, 2019
• Est. completion date: April 15, 2019

Study information

• Verified date: September 2020
• Source: Beni-Suef University
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 804
• Est. completion date: April 15, 2019
• Est. primary completion date: April 15, 2019
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

• Oral Ulcer
• Oral Ulcer Due to Benign Mucous Membrane Pemphioid
• Oral Ulcer Due to Pemphius Vularis
• Oral Ulcer Due to Steven Johnson's Syndrome
• Stevens-Johnson Syndrome
• Ulcer

Intervention

Biological:
• Platelet rich fibrin gel in Orabase
applied on oral mucositis and /or ulcer 3 times per day

Drug:
• Dermovate cream in Orabase
applied on oral mucositis and /or ulcer 3 times per day

Locations

Country	Name	City	State
Egypt	Eman Ahmed	Beni-Suef	Beni Suef

Sponsors (1)

Lead Sponsor	Collaborator
Beni-Suef University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	1 week
Secondary	Mucositis	WHO mucositis score, graded from 0 to 4 were 0 no mucositis and 4 severe mucositis, obtaining lower values reflects improvement	2 weeks
Secondary	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	2 weeks
Secondary	ulcer number	number counted for each patient, decrease in number reflects improvement	2 weeks