PRF in Management of Chronic Multiple Oral Ulcers

Platelet Rich-plasma in Management of Chronic Multiple Oral Ulcers

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.

Study Overview

• Status: Completed
• Conditions: Oral Ulcer Due to Pemphius Vularis; Oral Ulcer Due to Benign Mucous Membrane Pemphioid; Oral Ulcer Due to Steven Johnson's Syndrome
• Intervention / Treatment: Biological: Platelet rich fibrin gel in Orabase; Drug: Dermovate cream in Orabase

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.

• Study Type: Interventional
• Enrollment (Actual): 804
• Phase: Phase 1

Contacts and Locations

Study Locations

• Egypt
  • Beni Suef
    • Beni-Suef, Beni Suef, Egypt, 1178
      • Eman Ahmed

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult; Older Adult
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: autologous Platelet rich fibrin in Orabase (PRF); applied to oral ulcer and/or mucositis 3 times per day	Biological: Platelet rich fibrin gel in Orabase; applied on oral mucositis and /or ulcer 3 times per day; Other Names: autologus PRF gel
Active Comparator: Clobetasol propionate 0.05%(Dermovate cream) in orabase; applied to oral ulcer and/or mucositis 3 times per day	Drug: Dermovate cream in Orabase; applied on oral mucositis and /or ulcer 3 times per day; Other Names: Clobetasol Propionate 0.05%

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Mucositis	WHO mucositis score, graded from 0 to 4 were 0 no mucositis and 4 severe mucositis, obtaining lower values reflects improvement	2 weeks
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
ulcer number	number counted for each patient, decrease in number reflects improvement	2 weeks

Collaborators and Investigators

• Sponsor: Beni-Suef University

Study record dates

Study Major Dates

• Study Start (Actual): March 13, 2019
• Primary Completion (Actual): April 15, 2019
• Study Completion (Actual): April 15, 2019

Study Registration Dates

• First Submitted: March 13, 2019
• First Submitted That Met QC Criteria: March 15, 2019
• First Posted (Actual): March 18, 2019

Study Record Updates

• Last Update Posted (Actual): September 7, 2020
• Last Update Submitted That Met QC Criteria: September 3, 2020
• Last Verified: September 1, 2020

More Information

Terms related to this study

• Keywords: Platelet rich fibrin, Oral Ulcer, Pain, Mucositis
• Additional Relevant MeSH Terms: Chemically-Induced Disorders; Pathologic Processes; Skin Diseases; Immune System Diseases; Stomatognathic Diseases; Mouth Diseases; Hypersensitivity; Erythema; Skin Diseases, Vesiculobullous; Dermatitis; Drug-Related Side Effects and Adverse Reactions; Stomatitis; Drug Eruptions; Erythema Multiforme; Drug Hypersensitivity; Ulcer; Oral Ulcer; Stevens-Johnson Syndrome; Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Sensory System Agents; Anesthetics; Anti-Inflammatory Agents; Glucocorticoids; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Anesthetics, Local; Clobetasol; Benzocaine
• Other Study ID Numbers: 00uad

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Yes
• IPD Sharing Time Frame: a
• IPD Sharing Supporting Information Type: Study Protocol

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No