Osteoradionecrosis Rate in Patients Undergoing Radiotherapy for Head and Neck Cancer Treatment: a Perspective Clinical Study.
| Registry | NCT04009161 |
|---|---|
| Status | Unknown |
| Study type | Observational |
| Enrollment | 160 (Estimated) |
| Sponsor | Catholic University of the Sacred Heart (Other) |
| Conditions | Head and Neck Cancer, Osteoradionecrosis, Radiotherapy Side Effect, Tooth Avulsion |
| Interventions | Tooth extraction (Procedure) |
| Dates | start 2017-03-14, primary completion 2023-06-01, completion 2025-06-01 (estimated), first posted 2019-07-05, last updated 2023-08-30 |
| Locations | 1 site in Italy |
Related Papers Related Patents Related Grants Related Experts
All trials for Head and Neck Cancer All trials for Osteoradionecrosis All trials of Tooth extraction
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).
Sex: All
Inclusion Criteria: * Patients willing to sign the informed consent form * Patients with diagnosis of HNC, with specific prescription of local radiotherapy, both for curative and palliative purpose, with or without chemotherapic treatment. * Patient with diagnosis of HNC, with specific prescription of local radiotherapy as an adjuvant to surgical resection, with or without chemotherapic treatment. Exclusion Criteria: * Patients participating to other clinical studies * Patients who refuse to participate in the study * Patients unable to attend the ambulatory visits scheduled by the protocol
| Facility | City | Country | Status |
|---|---|---|---|
| Catholic University of the Sacred Heart | Rome | Italy |