Radiation Field, Dose and Fractionation Related to Mandibular Complications

Is the Radiation Field, Dose and Fractionation Crucial for the Development of Mandibular Complications When Treating Malignancies in the Oropharyngeal Region?

Status

Recruiting

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT05412849

Enrollment

120

Registered

2022-06-09

Start date

2023-01-01

Completion date

2025-07-31

Last updated

2024-05-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Head and Neck Neoplasms, Osteoradionecrosis, Radiotherapy; Complications

Brief summary

Radiotherapy is inhibiting the healing capacity of the mandibular bone. Late complications as bone exposure, fracture of the jaw, osteoradionecrosis might be a consequence of this vulnerability. A factor that could be involved in the development of complications is field of radiation. There are limited number of studies investigating this relation. Retrospective analysis of a head and neck oncology register with prospectively included patients will be performed. Patients will be related to the University hospitals in Lund, Umea, Orebro, Stockholm. A thorough analysis of the medical journals in this group of patients will be performed. Included patients have been treated with combination of surgery and radiotherapy to treat malignancies in the head and neck region. At least 12 months follow up period is needed for inclusion. The scientific aim is to investigate weather the field of radiation and fractionation is crucial for developing the formentioned complications.

Interventions

RADIATIONRadiotherapy

Radiotherapy site, time perspective and dose

Study design

Observational model

CASE_CONTROL

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Inclusion criteria

* Clinical diagnosis of the head and neck malignancy * Must have recieved radiotherapy as primary treatment alone or combination treatment together with surgery

Exclusion criteria

* less than 12 months follow up * Under 18 years of age

Design outcomes

Primary

Measure	Time frame	Description
Complications related to dose, time and position of radiotherapy	The measurements will be done from the end of radiotherapy and atleast 1 year postoperatively.	Complications as Osteoradionecrosis will be identified and compared with the dose of radiation, how long ago since the radiotherapy was given and where in the mouth the complication has developed.

Countries

Sweden

Contacts

Primary ContactPhilip Fransson, Msc

philip.fransson@skane.se0046 761077255

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026