Schoen

Hyperbaric oxygen therapy did not improve outcome in irradiated patients requiring mandibular surgical implants for dental reconstruction

Clinical bottom line:

1. Peri-implant hyperbaric oxygen for dental implants into irradiated tissue did not improve the outcome.

2. HBO is not justified in these patients

Citation/s:1. Schoen PJ, Raghoebar GM, Bouma J, Reintsema H, Vissink A, Sterk W, Roodenburg JLN. Rehabilitation of oral function in head and neck cancer patients after radiotherapy with implant-retained dentures: Effects of hyperbaric oxygen therapy. Oral Oncology 2007;43:379-388

Lead author's name and fax: Pieter Schoen p.j.schoen@hccnet.nl

Three-part Clinical Question: For patients who have been irradiated in the area, does a course of hyperbaric oxygen, result in more successful placement of lower jaw implants for denture rehabilitation?

Search Terms: Late radiation injury; dental implants; prevention The Study:Non-blinded randomised controlled trial with intention-to-treat.

The Study Patients: Edentulous patients with past radiotherapy for head and neck malignancy and who required dental implants for prosthodontic rehabilitation.

Control group (N = 13; 13 analysed): Peri-operative broad spectrum antibiotics one day before and for two weeks after the placement of dental implants.

Experimental group (N = 13; 13 analysed): As above, plus 100% oxygen breathing at 2.5 ATA for 80 minutes daily 20 times pre-implantation and 10 after.

The Evidence:

 

Outcome

Time to Outcome

Control group

HBO group

Relative Risk Reduction

Absolute Risk Reduction

NNT

Number of patients with at least one lost implant

1 year

0.15

0.39

-150%

-0.23

4

95% CIs:

-364% to 64%

-0.56 to 0.10

NNT = 2 to INF; NNH = 10 to INF

Development of osteoradionecrosis

1 year

0

0.08

INF

-0.08

13

95% CIs:

 

-0.22 to 0.07

NNT = 5 to INF; NNH = 15 to INF

 

Measure

Control Group

Hyperbaric Group

Difference

95% CI

Mean

SD

Mean

SD

Oral Health Impact Profile (0 best to 36 worst) at one year

12.7

9.7

15.0

7.3

2.3

-4.7 to 9.3

Gronigen Activity Restriction Scale Dentistry (0 best to 22 worst) at 1 year

4.3

7.4

5.3

5.5

1.90

-4.3 to 6.3

 

Comments:

1. No power or sample size calculations were made - may be underpowered to find a clinically important difference.

2. No differences between groups in radiologic appearance or mouth dryness.

3. All results are given in text and tables as 'xx +/- yy', but there is no indication what this means. The statistical analysis section implies all data sets were analyzed using non-parametric tests. We have calculated the results here as if what was meant was mean and sd.

4. An open label study.

5. Neither group showed major improvements in quality of life scores.

Appraised by: Mike Bennett m.bennett@unsw.edu.au ; Monday, 17 June 2019

Kill or Update By: June 2022

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