Protocol for a randomized trial of hyperbaric oxygen versus 'PENTOCLO' for the treatment of osteoradionecrosis.

Clinical bottom line:

1. Protocol only – no data

Citation/s:1. Bulsara VM, Bulsara MK, Lewis E. Protocol for prospective randomised assessor-blinded pilot study comparing hyperbaric oxygen therapy with PENtoxifylline+ TOcopherol±CLOdronate for the management of early osteoradionecrosis of the mandible. BMJ open. 2019 Mar 1;9(3):e026662.
Lead author's name and fax: Vishal Bulsara: Vishal.Bulsara@gmail.com

Three-part Clinical Question:For patients with osteoradionecrosis of the mandible, does treatment with a combination of pentoxifylline, tocopherol and clodronate, compared to hyperbaric oxygen, result in better clinical outcomes?
Search Terms: Osteoradionecrosis, PENTOCLO

The Study:Assessor blinded randomised controlled trial with intention-to-treat.
The Study Patients: Patients diagnosed with grade 1 Notani score ORN by an Oral and Maxillofacial surgeon, ORN defined as an area of exposed devitalized irradiated bone that fails to heal over a period of 3 to 6 months in the absence of local neoplastic disease and is greater than 20mm2 in area.
Control group (N = 8 ; analysed): Four weeks 'pre-treatment' with Amoxicillin/Clavulinic acid, fluconazole and prednisolone, followed by five days of pentoxifylline (400mg bd) and vitamin E 1000 IU daily Monday to Friday. If condition worsens, then clodronate 1600 mg daily Monday to Friday added for a total of 6 to 18 months. Antibiotics and or steroids can be prescribed if deterioration, or infection.
Experimental group (N = 8 ; analysed): Pre-treatment as above followed by 30 session of 100% oxygen breathing at 2.4 ATA for 90 minutes daily, Monday to Friday. If bone still exposed, a surgical removal followed by a further 10 sessions of oxygen as before. Pain or infection treated as for control group.

1. Protocol only published to date. Plan to study 16 patients in a pilot to assist in the establishment of a definitive RCT to follow.
2. Primary outcome: successful healing of ORN at 18 months defined as complete mucosal cover and absence of pain.
3. Secondary outcomes: complications of therapy.

Appraised by:Mike Bennett m.bennett@unsw.edu.au ; Saturday, 15 August 2020
Kill or Update By: May 2022