An observational study in Head and Neck Cancer, Osteoradionecrosis and Radiotherapy Side Effect, sponsored by Catholic University of the Sacred Heart. Status unknown at 1 site in Italy. Per ClinicalTrials.gov, last updated 2023-08-30.
Sponsored by Catholic University of the Sacred Heart · Observational
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).
2,402 studies on the registry are indexed under Head and Neck Neoplasms; 559 are open to participants now.
This study's planned enrollment of 160 is above the median of 100 across 453 observational studies indexed under Head and Neck Neoplasms.
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Patients irradiated for head and neck cancer
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Exclusion Criteria:
Tooth extraction before the beginning of radiotherapy in patients irradiated for Head and Neck cancer
Osteoradionecrosis Incidence
To evaluate the ORN incidence in a population irradiated for Head and Neck Cancer.
Time frame: 60 months after the beginning of RT
Osteoradionecrosis rate following pre-radiotherapy tooth extraction
Time frame: 60 months after the beginning of RT
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
Time frame: 60 months after the beginning of RT
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
Time frame: 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.
Tooth extraction related risk factors
Time frame: 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.
Tooth extraction related risk factors
Time frame: 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.
Tooth extraction related risk factors
Time frame: 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.
Tooth extraction related risk factors
Time frame: 60 months after the beginning of RT
Radiation dose to the post-extractive site (Gy of radiation received by every post-extractive site)
Tooth extraction related risk factors
Time frame: 60 months after the beginning of RT
Age of every patients at the beginning of RT
ORN risk factors
Time frame: At baseline
Sex (male, female) of every patients at the beginning of RT
ORN risk factors
Time frame: At baseline
Number of participants undergoing concurrent chemotherapy (neoadjuvant or concomitant)
ORN risk factors
Time frame: During treatment
Plan to share: Undecided
This study is status unknown, as verified in Aug 2023. You cannot join it, but the record below documents what was studied.
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