This study has been designed to find out whether the use of oxygen treatment may help your jaw heal after minor Surgery. Healing problems can occur more often after radiotherapy.
We will take precautions to reduce the effects of Surgery, but even so there is a small risk of healing difficulties. Having the extra oxygen treatment might prevent this although at the moment nobody knows this for certain.
This trial is to find whether there is any difference between two different types of treatment. If you agree to take part, you will be randomly allocated to one of two groups:
1) Surgery with antiseptic mouthwash and antibiotics.
2) Surgery with antiseptic mouthwash and antibiotics, also with oxygen treatment.
This means that half of all patients will be given oxygen treatment. Therefore whether you are allocated to be treated with oxygen will be decided by chance. Whichever group you are allocated you will be monitored closely.
- HOPON (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis): A Randomized Controlled Trial of Hyperbaric Oxygen to Prevent Osteoradionecrosis of the Irradiated Mandible After Dentoalveolar Surgery. Shaw R, et al., (2019): https://doi.org/10.1016/j.ijrobp.2019.02.044 HOPON (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis): a randomised controlled trial of hyperbaric oxygen to prevent osteoradionecrosis of the irradiated mandible: study protocol for a randomised controlled trial. Shaw R, et al., (2018): doi: 10.1186/s13063-017-2376-7. Refining the definition of mandibular osteoradionecrosis in clinical trials: The cancer research UK HOPON trial (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis). Shaw R, et al., (2017): doi: 10.1016/j.oraloncology.2016.12.002. Epub 2016 Dec 10. Shaw RJ, Butterworth CJ, Silcocks P, Tesfaye BT, Bickerstaffe M, Jackson R, Kanatas A, Nixon P, McCaul J, Praveen P, Lowe T, Blanco-Guzman M, Forner L, Brennan P, Fardy M, Parkin R, Smerdon G, Stephenson R, Cope T, Glover M. HOPON (Hyperbaric Oxygen for the Prevention of Osteoradionecrosis): a randomised controlled trial of hyperbaric oxygen to prevent osteoradionecrosis of the irradiated mandible after dentoalveolar Surgery. Int J Radiat Oncol Biol Phys. 2019 Mar 6. pii: S0360-3016(19)30288-3. doi: 10.1016/j.ijrobp.2019.02.044. [Epub ahead of print] PubMed PMID: 30851351