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

August 18, 2021 updated by: Francesco Gianfreda, University of Rome Tor Vergata

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

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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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:

  1. Sroussi HY, Epstein JB, Bensadoun RJ, et al. Common oral complications of head and neck can-cer radiation therapy: mucositis, infections, saliva change, fibrosis, sensory dysfunctions, dental caries, periodontal disease, and osteoradionecrosis. Cancer Med 2017;6(12):2918-2931. DOI: 10.1002/cam4.122
  2. White S, Pharoah M. Oral radiology: principles and interpretation, 7th ed. St. Louis: Elsevier; 2014
  3. Bensinger W, Schubert M, Ang KK, Brizel D, Brown E, Eilers JG, et al. NCCN task force report. Prevention and management of mucositis in cancer care. J Natl Compr Canc Netw. 2008;6 Suppl 1:S1-21; quiz S22-24
  4. Bensinger W, Schubert M, Ang KK, Brizel D, Brown E, Eilers JG, et al. NCCN task force report. Prevention and management of mucositis in cancer care. J Natl Compr Canc Netw. 2008;6 Suppl 1:S1-21; quiz S22-24
  5. Baharvand M, Sarrafi M, Alavi K, Moghaddam EJ. Efficacy of topical phenytoin on chemothera-py-induced oral mucositis; a pilot study. Daru. 2010;18:46-50
  6. Meyer-Hamme G, Beckmann K, Radtke J, Efferth T, Greten HJ, Rostock M, et al. A survey of chinese medicinal herbal treatment for chemotherapy-induced oral mucositis. Evid Based Com-plement Alternat Med. 2013;2013:284959
  7. Carulli G, Rocco M, Panichi A, Chios CF, Ciurli E, Mannucci C, et al. Treatment of oral mucositis in hematologic patients undergoing autologous or allogeneic transplantation of peripheral blood stem cells: a prospective, randomized study with a mouthwash containing Camelia Sinensis leaf extract. Hematol Rep. 2013;5:21-25
  8. Squier C, Brogden K. Human oral mucosa. Chichester, West Sussex, U.K.: Wiley-Blackwell; 2011
  9. White S, Pharoah M. Oral radiology: principles and interpretation, 7th ed. St. Louis: Elsevier; 2014
  10. Al-Ansari S, Zecha JAEM, Barasch A, de Lange J, Rozema FR, Raber- Durlacher JE. Oral mu-cositis induced by anticancer therapies. Curr Oral Health Rep (2015) 2:202-11. doi:10.1007/s40496-015-0069-4
  11. Picardi A, Miranda M, Liciani F, Paterno G, Arcese W, Bollero P. Identification of oral risk fac-tors for chronic graft versus host disease in haematological patients who underwent allogeneic haematopoietic stem cell transplantation. Oral Implantol (Rome). 2017 Jan 21;10(4):390-397. doi:10.11138/orl/2017.10.4.390. eCollection 2017 Oct-Dec. PubMed PMID: 29682256;PubMed Cen-tral PMCID: PMC5892662.
  12. Lalla RV, Sonis ST, Peterson DE. Management of oral mucositis in patients who have cancer. Dent Clin North Am (2008) 52(1):61-77,viii. doi:10.1016/j. cden.2007.10.002
  13. Lalla RV, Bowen J, Barasch A, Elting L, Epstein J, Keefe DM, et al. MASCC/ ISOO clinical prac-tice guidelines for the management of mucositis secondary to cancer therapy. Cancer (2014) 120(10):1453-61. doi:10.1002/cncr.2859 14 Lalla RV. The MASCC/ISOO mucositis guidelines update: introduction to the first set of articles. Support Care Cancer (2013) 21(1):301-2. doi:10.1007/ s00520-012-1660-z

15) Lalla RV, Ashbury FD. The MASCC/ISOO mucositis guidelines: dissemination and clinical im-pact. Support Care Cancer (2013) 21(11):3161-3. doi:10.1007/s00520-013-1924-2 16) Bollero P., Franco R., Gianfreda F., Gualtieri P., Miranda M., Barlattani A. Epidemiology, Eti-opathogenesis, Treatment and Prognosis of Oral Thermal Burns from Food and Drinks. Dental Hy-potheses 2019. 10. 80. 10.4103/denthyp.denthyp_56_19.

17) Avci P, Gupta A, Sadasivam M, et al. Low-level laser (light) therapy (LLLT) in skin: stimulating, healing, restoring. Semin Cutan Med Surg 2013;32(1):41-52 18) Bollero, P., Rocco, F., Gianfreda, F., Miranda, M., Ottria, L., & Barlattani, A. (2019). The influ-ence of pemphigus vulgaris on oral health. ORAL & IMPLANTOLOGY, 12(2), 174-179.

19) Lin P, Sermersheim M, Li H, et al. Zinc in wound healing modulation. Nutrients 2017;10(1):E16. DOI: 10.3390/nu10010016 20) Maria OM, Eliopoulos N, Muanza T. Radiation-Induced Oral Mucositis. Front Oncol. 2017 May 22;7:89. doi: 10.3389/fonc.2017.00089 21) Picardi A, Ferraro AS, Miranda M, Meconi F, Lanti A, Adorno G, Arcese W, Bollero P. Therapeu-tic efficiency of platelet gel for the treatment of oral ulcers related to chronic graft versus host disease after allogeneic haematopoietic stem cell transplantation. Oral Implantol (Rome). 2017 Jan 21;10(4):398-405. doi: 10.11138/orl/2017.10.4.398. eCollection 2017 Oct-Dec. PubMed PMID: 29682257; PubMed Central PMCID: PMC5892654 22) Cantore S, Crincoli V, Boccaccio A, Uva AE, Fiorentino M, Monno G, Bollero P, Derla C, Fabiano F, Ballini A, Santacroce L. Recent Advances in Endocrine, Metabolic and Immune Disorders: Mes-enchymal Stem Cells (MSCs) and Engineered Scaffolds. Endocr Metab Immune Disord Drug Tar-gets. 2018;18(5):466-469. doi:10.2174/1871530318666180423102905. Review. PubMed PMID: 29692270.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
15

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Italy
      • Taviano, Italy, 73057
        • Francesco Gianfreda

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

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

Description

Inclusion Criteria:

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.

Exclusion Criteria:

Systemic Healthy Patients

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Complete Oral Mucositis Healing
Time Frame: 1 week
Healing of oral lesions
1 week

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University of Rome Tor Vergata

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Study Director: Patrizio Bollero, Dentistry, University of Rome Tor Vergata

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
July 1, 2017

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 1, 2019

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
July 19, 2021

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 18, 2021

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2021

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2021

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2021

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 18, 2021

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • 25071995

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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