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

August 29, 2023 updated by: Carlo Lajolo, Catholic University of the Sacred Heart

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

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).

Study Overview

Status

Active, not recruiting

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Estimated)

160

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
      • Rome, Italy, 00168
        • Catholic University of the Sacred Heart

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

Ages Eligible for Study

  • Child
  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Sampling Method

Non-Probability Sample

Study Population

Patients irradiated for head and neck cancer

Description

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

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

  • Observational Models: Cohort
  • Time Perspectives: Prospective

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Osteoradionecrosis Incidence
Time Frame: 60 months after the beginning of RT
To evaluate the ORN incidence in a population irradiated for Head and Neck Cancer.
60 months after the beginning of RT
Osteoradionecrosis rate following pre-radiotherapy tooth extraction
Time Frame: 60 months after the beginning of RT
60 months after the beginning of RT

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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.
Time Frame: 60 months after the beginning of RT
Risk of ORN per extraction site
60 months after the beginning of RT
Time interval between extraction and Radiotherapy: days between every tooth extraction and the beginning of RT.
Time Frame: 60 months after the beginning of RT
To understand the relationship between this time-lapse and the ORN incidence
60 months after the beginning of RT
Surgical protocol 1: Flap elevation per each extracted tooth (YES/NO) and percentage of ORN per each type of procedure.
Time Frame: 60 months after the beginning of RT
Tooth extraction related risk factors
60 months after the beginning of RT
Surgical protocol 2: Primary intention closure achievement per post-extractive site (YES/NO) and percentage of ORN per each type of procedure.
Time Frame: 60 months after the beginning of RT
Tooth extraction related risk factors
60 months after the beginning of RT
Surgical protocol 3: Osteotomy per each extracted tooth (YES/NO) and percentage of ORN per each type of procedure.
Time Frame: 60 months after the beginning of RT
Tooth extraction related risk factors
60 months after the beginning of RT
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.
Time Frame: 60 months after the beginning of RT
Tooth extraction related risk factors
60 months after the beginning of RT
Radiation dose to the post-extractive site (Gy of radiation received by every post-extractive site)
Time Frame: 60 months after the beginning of RT
Tooth extraction related risk factors
60 months after the beginning of RT
Age of every patients at the beginning of RT
Time Frame: At baseline
ORN risk factors
At baseline
Sex (male, female) of every patients at the beginning of RT
Time Frame: At baseline
ORN risk factors
At baseline
Number of participants undergoing concurrent chemotherapy (neoadjuvant or concomitant)
Time Frame: During treatment
ORN risk factors
During treatment

Collaborators and Investigators

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

Sponsor

Catholic University of the Sacred Heart

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)

March 14, 2017

Primary Completion (Actual)

June 1, 2023

Study Completion (Estimated)

June 1, 2025

Study Registration Dates

First Submitted

June 19, 2019

First Submitted That Met QC Criteria

July 3, 2019

First Posted (Actual)

July 5, 2019

Study Record Updates

Last Update Posted (Actual)

August 30, 2023

Last Update Submitted That Met QC Criteria

August 29, 2023

Last Verified

August 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • ORN-HN-1

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

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.

Clinical Trials on Head and Neck Cancer

Clinical Trials on Tooth extraction

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Luxembourg

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe