Clinical trial · Observational
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.
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Summary
Brief summary (as posted)
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
Conditions (4)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Head and Neck Cancer | Malignant Head and Neck Neoplasm | ALIAS | 0.90 |
| Osteoradionecrosis | — | UNRESOLVED | — |
| Radiotherapy Side Effect | — | UNRESOLVED | — |
| Tooth Avulsion | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| Tooth extraction | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (0)
[]Primary outcomes (2)
- measure
- Osteoradionecrosis Incidence
- timeFrame
- 60 months after the beginning of RT
- description
- To evaluate the ORN incidence in a population irradiated for Head and Neck Cancer.
- measure
- Osteoradionecrosis rate following pre-radiotherapy tooth extraction
- timeFrame
- 60 months after the beginning of RT
Secondary outcomes (10)
- measure
- 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.
- timeFrame
- 60 months after the beginning of RT
- description
- Risk of ORN per extraction site
- measure
Eligibility
Eligibility (as posted)
- Sex
- All
Show eligibility criteria text
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
References
Publications (3)
- DERIVEDRupe C, Gioco G, Tranfa M, Scilla F, Schiavelli A, Cairo F, Galli J, Scambia G, Rengo C, Lajolo C. Differences in oral health status between cancer patients: a case-control observational study. BMC Oral Health. 2025 Dec 1;25(1):1862. doi: 10.1186/s12903-025-06963-7. PMID 41327109
- DERIVEDRupe 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
- DERIVEDRupe 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