The Impact of Dental Health on Complications During and Following Radiotherapy in the Head and Neck Region.

February 20, 2025 updated by: Lund University Hospital
Study the risk of complications after dental extractions in patients recieving radiotherapy.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Detailed Description

Dental extractions before radiotherapy in the head and neck region is an established part of the treatment plan for patients with malignant disease. There are contradictory results in the literature regarding the importance timing and magnitude of extractions. It is important to minimize complications in this patient group since the regular therapy is already detrimental to the affected tissues. Patients were extracted from the ARTSCAN register were the population was followed for 4 years for several factors, including development of osteoradionecrosis. The aim is to evaluate which diagnoses are more prone to develop complications after extraction. If there is a relationship between occurrence of complication and magnitude of dental pathology.

Study Type

Observational

Enrollment (Actual)

750

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Sweden
    • Skåne
      • Lund, Skåne, Sweden
        • Oral and Maxillofacial Department

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

Yes

Sampling Method

Probability Sample

Study Population

All patients receiving radiotherapy for malignant diagnosis (oral and oropharyngeal cancers)

Description

Inclusion Criteria:

  • Malignant diagnosis
  • radiotherapy pre or postoperative

Exclusion Criteria:

-

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
Dental extractions with complications
patients recieving dental extractions and developing osteoradionecrosis
Procedure: Dentoalveolar surgery
Surgery to extract teeth
Dental extractions without complications
patients recieving dental extractions and not developing osteoradionecrosis

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Does dental extractions increase the risk for complications such as osteoradionecrosis?
Time Frame: From diagnosis of head and neck pathology, approximately 1 month before start of radiotherapy, and to the end of the medical record which may be from one year after the oncologic treatment up to 26 years after oncologic treatment.
Type of complication when extracting teeth in conjunction with radiotherapy.
From diagnosis of head and neck pathology, approximately 1 month before start of radiotherapy, and to the end of the medical record which may be from one year after the oncologic treatment up to 26 years after oncologic treatment.
Does dental pathology in extracted teeth correlate with development of osteoradionecrosis?
Time Frame: From diagnosis of head and neck pathology, approximately 1 month before start of radiotherapy, and to the end of the medical record which may be from one year after the oncologic treatment up to 26 years after oncologic treatment.
Are any specific dental pathology more prone to develop complications than others?
From diagnosis of head and neck pathology, approximately 1 month before start of radiotherapy, and to the end of the medical record which may be from one year after the oncologic treatment up to 26 years after oncologic treatment.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Lund University Hospital

Investigators

  • Principal Investigator: Philip Fransson, Msc, Lund University Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

January 1, 2024

Primary Completion (Actual)

December 1, 2024

Study Completion (Actual)

January 1, 2025

Study Registration Dates

First Submitted

November 8, 2024

First Submitted That Met QC Criteria

February 20, 2025

First Posted (Actual)

March 25, 2025

Study Record Updates

Last Update Posted (Actual)

March 25, 2025

Last Update Submitted That Met QC Criteria

February 20, 2025

Last Verified

November 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • LundUH2

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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