PENtoxyphylline+TOcopherol+/-CLOdronate (PENTOCLO) vs Hyperbaric oxygen (HBO): a randomised assessor blinded pilot study comparing two therapies for Osteoradionecrosis of the mandible.

Phase 3

• Conditions: osteoradionecrosis of the mandible; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Cancer - Head and neck

• Registration Number: ACTRN12618001099213
• Lead Sponsor: Dr Emma Lewis

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2018-07-02
• Last Update Posted: 12 November 2018

Recruitment & Eligibility

• Status: ot yet recruiting
• Sex: All
• Target Recruitment: 16

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Proportion of participants with an improvement of ORN of the mandible as defined by improvement in both Notani and Lyons scoring systems.[2,4,6,8,12 weeks after beginning the pre-treatment therapy then 6,9,12,18 months after beginning the pre-treatment therapy. Primary outcome will be assessed at all time points after the baseline examination. ];Proportion of participants with complete healing of ORN of the mandible as defined by both Notani and Lyons scoring.[2,4,6,8,12 weeks after beginning the pre-treatment therapy then 6,9,12,18 months after beginning the pre-treatment therapy. Primary outcome will be assessed at all time points after the baseline examination. ]