NCT06840639

Brief Summary

Study the risk of complications after dental extractions in patients recieving radiotherapy.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
750

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2024

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2024

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

November 8, 2024

Completed
23 days until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2024

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2025

Completed
2 months until next milestone

First Posted

Study publicly available on registry

February 21, 2025

Completed
Last Updated

February 21, 2025

Status Verified

November 1, 2024

Enrollment Period

11 months

First QC Date

November 8, 2024

Last Update Submit

February 20, 2025

Conditions

Outcome Measures

Primary Outcomes (2)

  • Does dental extractions increase the risk for complications such as osteoradionecrosis?

    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?

    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.

Study Arms (2)

Dental extractions with complications

patients recieving dental extractions and developing osteoradionecrosis

Procedure: Dentoalveolar surgery

Dental extractions without complications

patients recieving dental extractions and not developing osteoradionecrosis

Interventions

Surgery to extract teeth

Dental extractions with complications

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • Malignant diagnosis
  • radiotherapy pre or postoperative

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Oral and Maxillofacial department

Lund, Skåne County, Sweden

Location

MeSH Terms

Conditions

Head and Neck Neoplasms

Condition Hierarchy (Ancestors)

Neoplasms by SiteNeoplasms

Study Officials

  • Philip Fransson, Msc

    Lund University Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
OTHER
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 8, 2024

First Posted

February 21, 2025

Study Start

January 1, 2024

Primary Completion

December 1, 2024

Study Completion

January 1, 2025

Last Updated

February 21, 2025

Record last verified: 2024-11

Locations