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RecruitingNCT05412849Updated May 23, 2024

Radiation Field, Dose and Fractionation Related to Mandibular Complications

An observational study in Head and Neck Neoplasms, Osteoradionecrosis and Radiotherapy; Complications, sponsored by Lund University Hospital. Recruiting at 1 site in Sweden. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2024-05-23.

Sponsored by Lund University Hospital · Observational

From the registry’s dates

  • Primary completion was expected by Jan 2025, 1 year 10 months ago, but the record still lists the study as recruiting.
  • Started Jan 2023; still recruiting 3 years 10 months later.
Study type
Observational
Model
Case-control
Time perspective
Retrospective
Enrollment
120
Ages
18 Years and older
Sex
All
01

Study 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.

02

Conditions studied

  • Head and Neck Neoplasms
  • Osteoradionecrosis
  • Radiotherapy; Complications
03

In context

Head and Neck Neoplasms

2,710 studies on the registry are indexed under Head and Neck Neoplasms; 594 are open to participants now.

This study's planned enrollment of 120 is above the median of 100 across 502 observational studies indexed under Head and Neck Neoplasms.

Browse Head and Neck Neoplasms studies →

Lead sponsor

Lund University Hospital is the lead sponsor of 66 studies on the registry; 15 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Sampling method
Probability sample

Study population

Consecutively included patients treated for head and neck neoplasms with a combination of surgery and radiotherapy.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

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

Exclusion criteria

Exclusion criteria

  • less than 12 months follow up
  • Under 18 years of age
Terms in these criteria, in plain language(1)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Cancer (malignancy)

Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.

Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.

05

Study design

Observational model
Case-control
Time perspective
Retrospective
Enrollment
120 participants (estimated)
Patient registry
No

Interventions

  • RadiationRadiotherapy

    Radiotherapy site, time perspective and dose

06

What researchers measure

Primary outcomes

  1. Complications related to dose, time and position of radiotherapy

    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.

    Time frame: The measurements will be done from the end of radiotherapy and atleast 1 year postoperatively.

07

Study locations

1 of 1 sites recruiting
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 23, 2024, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05412849
Lead sponsor
Lund University Hospital
Responsible party
Sponsor
First posted
Jun 9, 2022
Start date
Jan 1, 2023
Primary completion
Jan 2025 (estimated)
Completion
Jul 2025 (estimated)
Last update
May 23, 2024

Study contacts

Philip Fransson, Msc
Contact
philip.fransson@skane.se
0046 761077255
Martin Bengtsson, PhD
principal investigator · Lund University Hospital

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

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