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PRF in Management of Chronic Multiple Oral Ulcers

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ClinicalTrials.gov Identifier: NCT03878771
Recruitment Status : Not yet recruiting
First Posted : March 18, 2019
Last Update Posted : March 18, 2019
Sponsor:
Information provided by (Responsible Party):
Eman Magdy Ahmed, Beni-Suef University

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.

Condition or disease Intervention/treatment Phase
Oral Ulcer Due to Pemphius Vularis Oral Ulcer Due to Benign Mucous Membrane Pemphioid Oral Ulcer Due to Steven Johnson's Syndrome Biological: Platelet rich fibrin gel in Orabase Drug: Dermovate cream in Orabase Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 20 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention 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)
Primary Purpose: Treatment
Official Title: Platelet Rich-plasma in Management of Chronic Multiple Oral Ulcers
Estimated Study Start Date : March 13, 2019
Estimated Primary Completion Date : April 15, 2019
Estimated Study Completion Date : April 15, 2019


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 Name: 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 Name: Clobetasol Propionate 0.05%




Primary Outcome Measures :
  1. Pain score [ Time Frame: 1 week ]
    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 :
  1. Mucositis [ Time Frame: 2 weeks ]
    WHO mucositis score, graded from 0 to 4 were 0 no mucositis and 4 severe mucositis, obtaining lower values reflects improvement

  2. ulcer size [ Time Frame: 2 weeks ]
    Measurement in cm for the largest ulcer, expressed as maximum height x maximum width reflecting the average size, decrease in size is improvement

  3. ulcer number [ Time Frame: 2 weeks ]
    number counted for each patient, decrease in number reflects improvement



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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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

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Responsible Party: Eman Magdy Ahmed, Lecturer of Oral Medicine and Dianosis, Beni-Suef University
ClinicalTrials.gov Identifier: NCT03878771    
Other Study ID Numbers: 00uad
First Posted: March 18, 2019    Key Record Dates
Last Update Posted: March 18, 2019
Last Verified: March 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Supporting Materials: Study Protocol
Time Frame: a

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Eman Magdy Ahmed, Beni-Suef University:
Platelet rich fibrin, Oral Ulcer, Pain, Mucositis
Additional relevant MeSH terms:
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Stevens-Johnson Syndrome
Oral Ulcer
Ulcer
Pathologic Processes
Stomatitis
Mouth Diseases
Stomatognathic Diseases
Drug Eruptions
Dermatitis
Skin Diseases
Erythema Multiforme
Erythema
Skin Diseases, Vesiculobullous
Drug Hypersensitivity
Hypersensitivity
Immune System Diseases
Drug-Related Side Effects and Adverse Reactions
Chemically-Induced Disorders
Clobetasol
Benzocaine
Anti-Inflammatory Agents
Glucocorticoids
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Anesthetics, Local
Anesthetics
Central Nervous System Depressants
Sensory System Agents
Peripheral Nervous System Agents