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

Graft Vs Host Disease Clinical Trial

Official title: Treatment of Oral Mucositis Using Platelet Rich Fibrin: a Retrospective Study in Oncological Patients.

Status Completed

Clinical Trial 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.

Clinical Trial Description

Oral mucositis (OM) is a reversible common painful and debilitating iatrogenic lesion due to anti-cancer therapy. Depending on the intensity and dose of chemotherapy or radiotherapy, stomatitis or oral mucositis can significantly contribute to the reduction of patients' quality of life. [1]. The purpose of radiotherapy or chemotherapy therapies is to target rapidly duplicating cells and this triggers unwanted effects on oral and gastrointestinal mucosa, skin, bone marrow, hair follicles, and the tissues adjacent to the target [2].

OM can present with different characteristics of which the most common are edematous and ery-thematous areas, major ulcerations, pain and bleeding. In the most serious cases there is a diffi-culty in drinking, eating and speaking [3]. What is more, in severe cases it can damage patients' quality of life [4-5].

From a biochemical point of view, OM are caused by different molecular patterns such as oxida-tion produced by nitric oxide which causes cell apoptosis or the action of cyclooxygenases, protein kinases, cytokines and nuclear factors. Another interesting aspect to consider is the presence of epigenetic risk factors that target DNA methylation. [6,7] Oral mucositis mainly affects the non-keratinized oral mucosa as it has a cell turnover of 14 days which is twice as fast as keratinized gingiva. The areas of the oral cavity in which it is generally difficult to find this type of lesions are the hard palate, the dorsum of the tongue and the keratin-ized gingiva as they have a slower cell turnover (about 24 days) [8-9] To prevent the manifestation of these side effects, the guidelines of the Multinational Association of Supportive Care in Cancer and the International Society of Oral Oncology have defined home and professional oral hygiene as the main tool to combat OM, candidiasis and the risk of second-ary infections [10-15]. Care must be taken in removing all those mechanical traumas that can cause iatrogenic lesions such as incongruous margins, incongruous prostheses and grinding bites. However, it is also important to pay attention to all those external agents aggravating oral health such as tobacco, alcohol, oral burns and UV rays for the lips. Zinc supplements have also been suggested to maintain cellular homeostasis or human recombinant Keratinocyte Growth Factor to prevent oral mucositis. [13,16] OM lesions can also lead to large ulcers that can be terribly debilitating for patients. Scientific as-sociations for the protection of cancer patients recognize a key role in pain control and the prophy-laxis or treatment of secondary infections [12-15]. The use of low-intensity laser (Low-Level-Laser Therapy) was also proposed, which thanks to photobiostimulation can enhance tissue healing, re-duce inflammation and limit pain [12-15-17]. Zinc supplements are cofactors for many enzymes maintaining cellular equilibrium, immune response, and wound healing. They are considered an antioxidant, that precludes oxidative damage to many biomolecules [19]. In the most debilitating and painful cases of OM it has been suggested the use of a 2% morphine mouthwash and 0.5% doxepin mouthwash [13]. Furthermore, according to a study by O. Muhammad et al. [20], the glycyrrhetic acid / povidone / sodium hyaluronate gel could provide a mechanical protective action to the mucous membranes with a consequent reduction in pain.

Growth factors have been widely used in various fields of medicine and dentistry with the aim of improving and accelerating healing processes. The use of non-transfusional blood components such as Plasma Rich in Fibrin (PRF) is of great interest as it contains platelets and leukocytes can promote neoangiogenesis, release chemotactic growth factors and some studies have shown that leukocytes have a factor protective even in situations where there may be a risk of osteonecrosis. [21-22] Aim of the study is to evaluate efficacy and safety of topical use of platelet gel rich in fibrin in clinical management and healing of oral mucositis in oncological patients in treatment with chemotherapy and/or radiotherapy.

REFERENCIES:

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Related Conditions & MeSH terms

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

• NCT number: NCT05018754
• Study type: Observational
• Source: University of Rome Tor Vergata
• Status: Completed
• Start date: July 1, 2017
• Completion date: July 19, 2021