Treatment of Oral Mucositis Using Platelet Rich Fibrin TREATMENT OF ORAL MUCOSITIS USING PRF

NCT05018754 | Completed

• 1 other identifier: 25071995
• Study Type: observational
• Target: 15
• Locations: 1 country
• Sites: 1

Brief Summary

Oral mucositis (OM) is an inflammatory mucosal demolition frequently observed during treatments for neoplastic diseases such as chemotherapy or radiation therapy. The side effects of these treat-ments often drastically reduce patients' quality of life. OM are the result of the systemic consequences of chemotherapy and radiotherapy which, due to their cytotoxic and local effects, lead to pain and severe ulceration with a consequent decrease in the quality of life of affected subjects. Plasma Rich in Fibrin is often used to enhance soft tissue wound healing and fight bacterial sepsis through the presence of leukocytes within it. Aim of the retrospective study was to evaluate efficacy and safety of topic use of platelet gel in clinical management of oral mucositis in order to improve life quality of patients.

Conditions

Graft Vs Host Disease; Oral Mucositis (Ulcerative); Mesenchymal Stem Cells

Keywords

PRF; Oral Mucositis

Outcome Measures

Primary Outcomes (1)

• Complete Oral Mucositis Healing

  Healing of oral lesions

  1 week

Interventions

TREATMENT OF ORAL MUCOSITIS USING PLATELET-RICH-FIBRIN (PRF) DEVICE

All patients were affected by oral mucositis (9 RIOM, 6 chemotherapy-related oral mucositis). They were treated with almost 2 different systemic therapies before and during platelets gel applications. Median of time before the lesions were treated with platelets gel were 7 days. Lesions affected buccal mucosa, tongue, labial commissure and lower lip. Preliminar parameters were the microbiological contamination of lesions and presence of pain. Patients refer spontaneous widespread pain worsened by swallowing and feeding. Response to treatment has been evaluated in relation to the reduction of lesions dimensions, to the involution of pain and presence of granulation tissue after every application of platelet gel.

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All patients were affected by oral mucositis due to RIOM or chemotherapy.

You may qualify if:

• All patients were affected by oral mucositis (9 RIOM, 6 chemotherapy-related oral mucositis). They were treated with almost 2 different systemic therapies before and during platelets gel applications. Median of time before the lesions were treated with platelets gel were 7 days. Lesions affected buccal mucosa, tongue, labial commissure and lower lip. Preliminar parameters were the microbiological contamination of lesions and presence of pain.

You may not qualify if:

• Systemic Healthy Patients

Sponsors & Collaborators

• University of Rome Tor Vergata: lead

Study Sites (1)

Francesco Gianfreda

Taviano, 73057, Italy

Location

Related Publications (4)

• Sroussi HY, Epstein JB, Bensadoun RJ, Saunders DP, Lalla RV, Migliorati CA, Heaivilin N, Zumsteg ZS. Common oral complications of head and neck cancer radiation therapy: mucositis, infections, saliva change, fibrosis, sensory dysfunctions, dental caries, periodontal disease, and osteoradionecrosis. Cancer Med. 2017 Dec;6(12):2918-2931. doi: 10.1002/cam4.1221. Epub 2017 Oct 25.

  PMID: 29071801 BACKGROUND

• Bensinger W, Schubert M, Ang KK, Brizel D, Brown E, Eilers JG, Elting L, Mittal BB, Schattner MA, Spielberger R, Treister NS, Trotti AM 3rd. NCCN Task Force Report. prevention and management of mucositis in cancer care. J Natl Compr Canc Netw. 2008 Jan;6 Suppl 1:S1-21; quiz S22-4.

  PMID: 18289497 BACKGROUND

• Agren MS, Rasmussen K, Pakkenberg B, Jorgensen B. Growth factor and proteinase profile of Vivostat(R) platelet-rich fibrin linked to tissue repair. Vox Sang. 2014 Jul;107(1):37-43. doi: 10.1111/vox.12120. Epub 2013 Dec 10.

  PMID: 24320875 BACKGROUND

• Hirase T, Ruff E, Surani S, Ratnani I. Topical application of platelet-rich plasma for diabetic foot ulcers: A systematic review. World J Diabetes. 2018 Oct 15;9(10):172-179. doi: 10.4239/wjd.v9.i10.172.

  PMID: 30364787 BACKGROUND

Biospecimen

Retention: SAMPLES WITH DNA

Patients affected by oral mucositis (9 RIOM, 6 chemotherapy-related oral mucositis).

MeSH Terms

Conditions

Graft vs Host Disease; Stomatitis; Ulcer

Condition Hierarchy (Ancestors)

Immune System Diseases; Mouth Diseases; Stomatognathic Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Patrizio Bollero, Dentistry

  University of Rome Tor Vergata

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: CASE ONLY
• Time Perspective: RETROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: PhD Student

Study Record Dates

• First Submitted: August 18, 2021
• First Posted: August 24, 2021
• Study Start: July 1, 2017
• Primary Completion: May 1, 2019
• Study Completion: July 19, 2021
• Last Updated: August 24, 2021

Record last verified: 2021-08

Data Sharing

• IPD Sharing: Will not share

Locations

IT (1)