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Hyperbaric Oxygen Treatment of Mandibular Osteoradionecrosis. A Randomized Clinical Study

NCT00760682 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 114

Last updated 2012-05-25

No results posted yet for this study

Summary

There is currently not sufficient evidence that hyperbaric oxygen (HBO) benefits the surgical removal of necrotic bone in osteoradionecrosis patients. This study aims at testing the hypothesis that HBO does improve healing after surgical removal of necrotic bone in irradiated previous head and neck cancer patients compared to not receiving HBO.

Conditions

  • Osteoradionecrosis

Interventions

PROCEDURE

Hyperbaric oxygen

30 preoperative and 10 postoperative HBO sessions 90 minutes each. Sequestrectomy is performed after 30 sessions.

Sponsors & Collaborators

  • Lone Forner

    lead OTHER

Principal Investigators

  • Lone Forner, DDS, PhD · Copenhagen University Hospital at Herlev

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2008-06-30
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • Denmark
  • Sweden
  • United Kingdom

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00760682 on ClinicalTrials.gov