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

NCT04009161 | Unknown

• 1 other identifier: ORN-HN-1
• Study Type: observational
• Target: 160
• Locations: 1 country
• Sites: 1

Brief 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

Outcome Measures

Primary Outcomes (2)

• Osteoradionecrosis Incidence

  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

  60 months after the beginning of RT

Secondary Outcomes (10)

• 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.

  60 months after the beginning of RT

• Time interval between extraction and Radiotherapy: days between every tooth extraction and the beginning of RT.

  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.

  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.

  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.

  60 months after the beginning of RT

Interventions

Tooth extraction PROCEDURE

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

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients irradiated for head and neck cancer

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Catholic University of the Sacred Heart: lead

Study Sites (1)

Catholic University of the Sacred Heart

Rome, 00168, Italy

Location

Related Publications (2)

• Rupe C, Gioco G, Massaccesi M, Tagliaferri L, Pastore F, Micciche F, Galli J, Mele D, Specchia ML, Cassano A, Cordaro M, Lajolo C. Osteoradionecrosis incidence in pre-radiation teeth extractions: A prospective study. Oral Dis. 2024 Nov;30(8):5129-5139. doi: 10.1111/odi.14941. Epub 2024 Apr 9.

  PMID: 38591808 DERIVED

• Rupe C, Gioco G, Almadori G, Galli J, Micciche F, Olivieri M, Cordaro M, Lajolo C. Oral Candida spp. Colonisation Is a Risk Factor for Severe Oral Mucositis in Patients Undergoing Radiotherapy for Head & Neck Cancer: Results from a Multidisciplinary Mono-Institutional Prospective Observational Study. Cancers (Basel). 2022 Sep 29;14(19):4746. doi: 10.3390/cancers14194746.

  PMID: 36230669 DERIVED

MeSH Terms

Conditions

Head and Neck Neoplasms; Osteoradionecrosis; Radiation Injuries; Tooth Avulsion

Interventions

Tooth Extraction

Condition Hierarchy (Ancestors)

Neoplasms by Site; Neoplasms; Wounds and Injuries; Tooth Injuries; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Oral Surgical Procedures; Surgical Procedures, Operative; Dentistry

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: June 19, 2019
• First Posted: July 5, 2019
• Study Start: March 14, 2017
• Primary Completion: June 1, 2023
• Study Completion: June 1, 2025
• Last Updated: August 30, 2023

Record last verified: 2023-08

Locations

IT (1)