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Clinical Trials/ACTRN12618001099213
ACTRN12618001099213
Not yet recruiting
Phase 3

Prospective randomised assessor blinded pilot study comparing Hyperbaric Oxygen therapy with PENTOCLO for the management of Osteoradionecrosis of the mandible.

Dr Emma Lewis0 sites16 target enrollmentJuly 2, 2018
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Conditionsosteoradionecrosis of the mandibleOral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colonCancer - Head and neck

Overview

Phase
Phase 3
Intervention
Not specified
Conditions
osteoradionecrosis of the mandible
Sponsor
Dr Emma Lewis
Enrollment
16
Status
Not yet recruiting
Last Updated
7 years ago
OverviewInvestigatorsEligibility CriteriaOutcomesSimilar Trials

Overview

Brief Summary

No summary available.

Registry
who.int
Start Date
July 2, 2018
End Date
TBD
Last Updated
7 years ago
Study Type
Interventional
Sex
All

Investigators

Sponsor
Dr Emma Lewis

Eligibility Criteria

Inclusion Criteria

  • •– Patients diagnosed with ORN by an Oral and Maxillofacial surgeon
  • •\- Patients or proxies that are able to give informed consent

Exclusion Criteria

  • •– Patients that have spontaneously healing ORN
  • •\-Patients that have undergone previous treatment for ORN (PENTO, HBO or surgery).
  • •\-Patients or proxies that are unable to give informed consent
  • •\-Patients that are pregnant at the time of therapy
  • •\-Patients that have received previous anti\-resorptive or anti\-angiogenic medications
  • •\-Patients requiring further surgical management for their Head and Neck cancer during the study period
  • •\-Patients diagnosed with ORN requiring urgent surgery
  • •\-Patients that are unable to be randomised

Outcomes

Primary Outcomes

Not specified

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