What is the role of hyperbaric oxygen in the management of bisphosphonate-related osteonecrosis of the jaw: a randomized controlled trial of hyperbaric oxygen as an adjunct to surgery and antibiotics.
OBJECTIVE
This study tested hyperbaric oxygen (HBO) as an adjunct to surgery and antibiotics in the treatment of bisphosphonate-related osteonecrosis of the jaw (ONJ) and evaluated its effects on gingival healing, pain, and quality of life.


METHODS
The investigators implemented a randomized controlled trial and enrolled a sample composed of patients with ONJ, where the predictor variable was HBO administered at 2 atm twice a day for 40 treatments as an adjunct to conventional therapy of surgery and antibiotics versus conventional therapy alone. Over the next 24 months, oral lesion size and number, pain, and quality of life were assessed.


RESULTS
Forty-six patients (mean age, 66 yrs; 57% women) contributed data to the trial. There were no statistically significant differences in the distribution of variables used to assess randomization success between the HBO and standard treatment groups. Seventeen of 25 HBO-treated patients (68%) improved versus 8 of 21 controls (38.1%; P = .043, χ(2) test). Mean time to improvement was 39.7 weeks (95% confidence interval [CI], 22.4 to 57.0 weeks) for HBO-treated patients versus 67.9 weeks (95 CI, 48.4 to 87.5 weeks) for controls (P = .03, log-rank test). However, complete gingival healing occurred in only 14 of 25 HBO-treated patients (52%) versus 7 of 21 controls (33.3%; P = .203, χ(2) test), and time to healing was 59 weeks (95% CI, 42.8% to 75.8%) for HBO-treated patients versus 70 weeks (95 CI, 52.2% to 88.36%) for controls (P = .32, log-rank test). Pain decreased faster for HBO-treated subjects (P < .01, linear regression). Quality-of-life scores for physical health (P = .002) and perceived health (P = .043) decreased at 6 months for control group but for not the HBO group.


CONCLUSIONS
ONJ is multifactorial and no single treatment modality is likely to reverse it; however, it is treatable and even advanced presentations can improve with intensive multimodal therapy. Clinically, HBO appears to be a useful adjunct to ONJ treatment, particularly for more severe cases, although this study was underpowered to fully support this claim.
Department of Anesthesiology, Center for Hyperbaric Medicine and Environmental Physiology, Duke University Medical Center, Durham, NC 27710, USA. john.freiberger@duke.edu
John J
JJ
Freiberger
Rebecca
R
Padilla-Burgos
Thomas
T
McGraw
Hagir B
HB
Suliman
Kevin H
KH
Kraft
Bryant W
BW
Stolp
Richard E
RE
Moon
Claude A
CA
Piantadosi
D000368:Aged; D019386:Alendronate / Q000009:adverse effects; D000900:Anti-Bacterial Agents / Q000627:therapeutic use*; D059266:Bisphosphonate-Associated Osteonecrosis of the Jaw / Q000188:drug therapy / Q000601:surgery / Q000628:therapy*; D050071:Bone Density Conservation Agents / Q000009:adverse effects; D001943:Breast Neoplasms / Q000188:drug therapy; D003131:Combined Modality Therapy; D003646:Debridement / Q000379:methods*; D004164:Diphosphonates / Q000009:adverse effects; D005260:Female; D005500:Follow-Up Studies; D005881:Gingiva / Q000473:pathology; D006801:Humans; D006931:Hyperbaric Oxygenation; D007093:Imidazoles / Q000009:adverse effects; D008297:Male; D009101:Multiple Myeloma / Q000188:drug therapy; D010024:Osteoporosis / Q000188:drug therapy; D059408:Pain Management; D000077268:Pamidronate; D011446:Prospective Studies; D011788:Quality of Life; D016896:Treatment Outcome; D014945:Wound Healing / Q000502:physiology; D000077211:Zoledronic Acid
D000900:Anti-Bacterial Agents; D050071:Bone Density Conservation Agents; D004164:Diphosphonates; D007093:Imidazoles; D000077211:Zoledronic Acid; D000077268:Pamidronate; D019386:Alendronate