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Osteoradionecrosis clinical trials

View clinical trials related to Osteoradionecrosis.

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NCT ID: NCT06055257 Not yet recruiting - Osteoradionecrosis Clinical Trials

Combination Therapy: Hyperbaric Oxygen and PENTOCLO for Treatment of Osteoradionecrosis of the Mandible

Start date: May 1, 2024
Phase: Phase 3
Study type: Interventional

Radiation is commonly used to treat cancer in the head and neck, however, this can lead to a serious complication called osteoradionecrosis (ORN), where there is necrotic (dead) open bone inside or outside of the mouth. This complication is difficult to treat, involves large healthcare costs, and can have devastating effects on quality of life. Two common adjuncts used in treatment of ORN are hyperbaric oxygen therapy (HBOT), which may requires up to 60 treatments at a specialized clinic where patients are treated with high concentrations of oxygen using special chambers, and a less complex option called PENTOCLO which involves treating patients with several antibiotics followed by a combination of other oral medications taken for at least 1 year. This pilot study will be guide the design of a definitive trial to examine if the combination of HBOT and a modified PENTOCLO protocol together is better than the current standard treatment of HBOT alone. Outcomes will include pain, side effects and the need for surgery in patients with ORN. Specifically, the results of this small, pilot study will help to inform the design of a future larger study.

NCT ID: NCT05412849 Recruiting - Clinical trials for Head and Neck Neoplasms

Radiation Field, Dose and Fractionation Related to Mandibular Complications

Start date: January 1, 2022
Phase:
Study type: Observational

Radiotherapy is inhibiting the healing capacity of the mandibular bone. Late complications as bone exposure, fracture of the jaw, osteoradionecrosis might be a consequence of this vulnerability. A factor that could be involved in the development of complications is field of radiation. There are limited number of studies investigating this relation. Retrospective analysis of a head and neck oncology register with prospectively included patients will be performed. Patients will be related to the University hospitals in Lund, Umea, Orebro, Stockholm. A thorough analysis of the medical journals in this group of patients will be performed. Included patients have been treated with combination of surgery and radiotherapy to treat malignancies in the head and neck region. At least 12 months follow up period is needed for inclusion. The scientific aim is to investigate weather the field of radiation and fractionation is crucial for developing the formentioned complications.

NCT ID: NCT05325970 Active, not recruiting - Clinical trials for Head and Neck Cancer

Clinical Registry of Long-Term Dental Outcomes in Head and Neck Cancer Patients

ORARAD II
Start date: February 2014
Phase:
Study type: Observational [Patient Registry]

The current study (ORARAD II) will examine participants of the original cohort for a visit roughly 7 years after the start of RT. The primary outcomes will be the 7-year rate of dental caries, periodontal disease, tooth loss, osteoradionecrosis and salivary flow.

NCT ID: NCT04934644 Recruiting - Osteoradionecrosis Clinical Trials

The Effect of Hyperbaric Oxygen Treatment in Patients With Osteoradionecrosis.

ORN
Start date: March 19, 2019
Phase: N/A
Study type: Interventional

Osteoradionecrosis (ORN) is a severe delayed radiation-induced injury that can occur in patients whom have been subjected to radiotherapy for head and neck cancer. Hyperbaric oxygen treatment (HBO) is one treatment option. In Sweden it is used in some locations in combination to standard treatment which includes for example antibiotics, pain medication and surgery. There is still not sufficient evidence that this treatment is effective in this group of patients. The primary aim of this study will be to evaluate HBO as a treatment for osteoradionecrosis in terms of slowing the progression of the disease, or at the best, cure the disease.

NCT ID: NCT04826445 Recruiting - Clinical trials for Mandibular Osteoradionecrosis

USE OF 18FDG PET-CT TO PREDICT THE RESPONSE OF MANDIBULAR OSTEORADIONECROSIS TO THE PENTOCLO PROTOCOL WITH DOCUMENTED ANTIBIOTHERAPY

PENTOTEP
Start date: June 11, 2019
Phase:
Study type: Observational

This study is created in order to refine and reduce the duration between the medical and surgical therapeutic sequences (when the surgery is necessary) in these fragile patients knowing that conventional radiological changes can only be observed with a delay comprised between 3 and 6 months starting from observed clinical changes.

NCT ID: NCT04717765 Completed - Clinical trials for Head and Neck Cancer

Photobiomodulation in Oral Lesions Resulting From Anti-neoplastic Prevention

Start date: February 10, 2021
Phase: N/A
Study type: Interventional

Introduction: There are several manifestations in the oral mucosa resulting from antineoplastic treatments by chemo (QT) or radiotherapy (RT). In this study we will collect the variables referring to oral mucositis (OM), radiodermatitis, osteonecrosis of the jaws (ONJ), hyposalivation and xerostomia, dysgeusia, pain, oral candidiasis (opportunistic infection), trismus, quality of life, oral hygiene. MO and hyposalivation, which are related to damage to the salivary glands, are the most common manifestations, and ONJ is the most difficult to treat. The dentist can play an important role in prevention and treatment these oral lesions, directly influencing the patient's quality of life and adherence to antineoplastic treatment. Objectives: The main objective is to evaluate the efficacy of the intervention, using LLL phototherapy and topical Vit E, in the OM. And the intervention through LLL phototherapy and LPRP in the ONJ. These interventions will be performed by dentists during antineoplastic medical treatment. Material and methods: clinical trial, randomized, with balanced randomization, single-blind (for the evaluator of the results) with 2 experimental arms and a control group, carried out in a single center. Group 1, intervention with LLL phototherapy, Group 2, intervention with application of topical Vit E and Group 3, mouthwash with 0.12% chlorhexidine (usual clinical information). 360 patients will participate in this study from the Units of Oncology Medicine, Radiotetaphic Medicine and Oral Medicine, Oral Surgery and Implantology at the University of Santiago de Compostela. The segment of the patients will be given, an initial visit and returns every day that hears the application of antineoplastic treatment for the group of LLL phototherapy, returns of 15 days, one month, three months, six months, nine months and one year. In these return visits, evaluations and questionnaires will be carried out regarding all the variables that we will collect. Predictable results: If the application of laser phototherapy or topical Vit E contributes to the cessation, reduction or improvement of the clinical evolution of the manifestation of oral lesions, these treatments could be immediately implemented in our Oral Medicine unit and could lay the foundations for its implementation in different public centers and private.

NCT ID: NCT04265430 Recruiting - Osteoradionecrosis Clinical Trials

Serial Magnetic Resonance Imaging for the Prediction of Radiation-Induced Changes in Normal Tissue of Patients With Oral Cavity or Skull Base Tumors

Start date: September 17, 2018
Phase: Phase 4
Study type: Interventional

This phase IV trial studies how well serial magnetic resonance imaging (MRI) after radiation therapy works in predicting radiation-induced changes in the normal tissue of patients with oral cavity or skull base tumors. Performing MRIs after radiation therapy for patients with oral cavity or skull base tumors may help to predict osteoradionecrosis (a change in non-cancerous tissue).

NCT ID: NCT04097847 Completed - Clinical trials for Osteoradionecrosis of Jaw

Osteoradionecrosis and PENTOCLO Protocol: Retrospective Study

OPEN
Start date: June 2, 2017
Phase:
Study type: Observational

osteoradionecrosis (ORN) affects up to 30% of irradiated patients and can occur up to several decades after stopping treatment. Differents therapeutics exist but there is no consensus concerning the management of the maxillary ORN. The understanding of new pathological mechanisms opens the way to new therapeutic perspectives.

NCT ID: NCT04009161 Active, not recruiting - Clinical trials for Head and Neck Cancer

Osteoradionecrosis Rate in Patients Undergoing Radiotherapy for Head and Neck Cancer Treatment.

Start date: March 14, 2017
Phase:
Study type: Observational

Objectives High-dose radiotherapy (RT) for head and neck cancer has significant adverse effects on maxillofacial tissues, among which osteoradionecrosis (ORN) is the most severe and potentially life-threatening. Although tooth extractions seem to be the main risk factor, few perspective studies evaluated protocols to minimize the ORN risk due to extractions. The aim of this study is to evaluate incidence and risk factors of ORN in a cohort of patients receiving tooth extractions before RT and evaluate an algorithm about extraction decision. Methods One-hundred ten patients were consecutively recruited in this study: impacted third molars with radiographic sign of pericoronitis, teeth with periapical lesions, unrestorable teeth, periodontally compromised teeth (pocket probing depth >5 mm, clinical attachment loss > 8 mm, grade 2 tooth mobility, II grade furcation involvement) were extracted under antibiotic prophylaxis. A 15-days interval between the last tooth extraction and the beginning of RT was recommended. Patients were visited at 15 days, 1, 3 and 6 months after the beginning of RT. Data of patients with a minimum of 6 months follow-up are presented in this report. ORN was defined as irradiated exposed necrotic bone, without healing for 3 months, in absence of cancer recurrence. The protocol was approved by the Ethic Committee of Catholic University - Fondazione Policlinico Gemelli (Prot. OHHN-1, ID-2132).

NCT ID: NCT03905005 Recruiting - Surgery Clinical Trials

Jaw Reconstruction With Printed Titanium and Free Tissue Transfer

JaW PrinT
Start date: March 12, 2018
Phase:
Study type: Observational

JaW PrinT is a prospective observational cohort study evaluating the effectiveness of two different techniques of mandibular reconstruction.