PRF in Management of Chronic Multiple Oral Ulcers

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

804 participants

Study Classification

INTERVENTIONAL

Study Start Date

2019-03-13

Study Completion Date

2019-04-15

Brief Summary

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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.

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Detailed Description

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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.

Conditions

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

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Patients with chronic multiple oral lesions due to benign mucous membrane Pemphigoid, Pemphigus vulgaris, ans Steven Johnson's Syndrome

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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autologous Platelet rich fibrin in Orabase (PRF)

applied to oral ulcer and/or mucositis 3 times per day

Group Type EXPERIMENTAL

Platelet rich fibrin gel in Orabase

Intervention Type BIOLOGICAL

applied on oral mucositis and /or ulcer 3 times per day

Clobetasol propionate 0.05%(Dermovate cream) in orabase

applied to oral ulcer and/or mucositis 3 times per day

Group Type ACTIVE_COMPARATOR

Dermovate cream in Orabase

Intervention Type DRUG

applied on oral mucositis and /or ulcer 3 times per day

Interventions

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Platelet rich fibrin gel in Orabase

applied on oral mucositis and /or ulcer 3 times per day

Intervention Type BIOLOGICAL

Dermovate cream in Orabase

applied on oral mucositis and /or ulcer 3 times per day

Intervention Type DRUG

Other Intervention Names

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autologus PRF gel Clobetasol Propionate 0.05%

Eligibility Criteria

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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