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

Head and Neck Cancer Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04009161
• Other study ID #: ORN-HN-1
• Status: Active, not recruiting
• Start date: March 14, 2017
• Est. completion date: June 1, 2025

Study information

• Verified date: August 2023
• Source: Catholic University of the Sacred Heart
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 160
• Est. completion date: June 1, 2025
• Est. primary completion date: June 1, 2023
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Procedure:
• Tooth extraction
Tooth extraction before the beginning of radiotherapy in patients irradiated for Head and Neck cancer

Locations

Country	Name	City	State
Italy	Catholic University of the Sacred Heart	Rome

Sponsors (1)

Lead Sponsor	Collaborator
Catholic University of the Sacred Heart

Country where clinical trial is conducted

Italy, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Osteoradionecrosis Incidence	To evaluate the ORN incidence in a population irradiated for Head and Neck Cancer.	60 months after the beginning of RT
Primary	Osteoradionecrosis rate following pre-radiotherapy tooth extraction		60 months after the beginning of RT
Secondary	Extraction site: number of tooth extractions for each site (anterior and posterior maxilla or mandible and specific tooth number) and percentage of ORN for each site.	Risk of ORN per extraction site	60 months after the beginning of RT
Secondary	Time interval between extraction and Radiotherapy: days between every tooth extraction and the beginning of RT.	To understand the relationship between this time-lapse and the ORN incidence	60 months after the beginning of RT
Secondary	Surgical protocol 1: Flap elevation per each extracted tooth (YES/NO) and percentage of ORN per each type of procedure.	Tooth extraction related risk factors	60 months after the beginning of RT
Secondary	Surgical protocol 2: Primary intention closure achievement per post-extractive site (YES/NO) and percentage of ORN per each type of procedure.	Tooth extraction related risk factors	60 months after the beginning of RT
Secondary	Surgical protocol 3: Osteotomy per each extracted tooth (YES/NO) and percentage of ORN per each type of procedure.	Tooth extraction related risk factors	60 months after the beginning of RT
Secondary	Reason for tooth extraction: number of tooth extraction for each cause under the protocol (caries, periodontal disease, endodontic lesions, pericoronitis, fracture) and percentage of ORN for each cause.	Tooth extraction related risk factors	60 months after the beginning of RT
Secondary	Radiation dose to the post-extractive site (Gy of radiation received by every post-extractive site)	Tooth extraction related risk factors	60 months after the beginning of RT
Secondary	Age of every patients at the beginning of RT	ORN risk factors	At baseline
Secondary	Sex (male, female) of every patients at the beginning of RT	ORN risk factors	At baseline
Secondary	Number of participants undergoing concurrent chemotherapy (neoadjuvant or concomitant)	ORN risk factors	During treatment