NCT04009161

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

Osteoradionecrosis Rate in Patients Undergoing Radiotherapy for Head and Neck Cancer Treatment: a Perspective Clinical Study.

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 160 (estimated)
• Sponsor: Catholic University of the Sacred Heart · Academic / Other
• Sex: All
• Age: —
• Healthy volunteers: Not accepted

Summary

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).

Conditions

• Head and Neck Cancer
• Osteoradionecrosis
• Radiotherapy Side Effect
• Tooth Avulsion

Interventions

Type	Name	Description
PROCEDURE	Tooth extraction	Tooth extraction before the beginning of radiotherapy in patients irradiated for Head and Neck cancer

Timeline

• Start date: 2017-03-14
• Primary completion: 2023-06-01
• Completion: 2025-06-01
• First posted: 2019-07-05
• Last updated: 2023-08-30

Locations

1 site across 1 country: Italy