Shaw_2019
Supportive Therapie · Version 2.1
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Ta_Referenz (Autor, Jahr, Journal) |
Studientyp Mono- vs. Multizentrisch, Verblindung, Randomisierung, Arme, Fallzahl n, Land, Zeitraum
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Patienten-merkmale Indikation, Alter, Geschlecht (m/w) |
Intervention Fallzahl n, Beschreibung der präventiven bzw. therapeutischen Maßnahme |
Kontrolle Fallzahl n, Beschreibung der präventiven Maßnahme bzw. therapeutischen Maßnahme |
Zielgrößen Primärer Endpunkt Sekundäre(r) Endpunkt(e) |
Primärer Endpunkt Angaben für Intervention vs. Kontrolle Sekundäre(r) Endpunkt(e) Angaben für Intervention vs. Kontrolle |
Finanzierung |
Evidenzstufe Bei Abwertung: Angabe von Gründen Bewertung des Autors |
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Shaw
2019
International Journal of Radiation Oncology |
randomized controlled phase 3 trial observer blinded
multicentre
n =144
UK, Denmark
2008 -2016 |
Planned dental extractions or implant placement in the mandible with prior radiotherapy >50Gy
Age yrs mean (SD): 58.2 (10.1)
Males, n(%): 28 (28%)
Smoking, n(%) Never: 31 (31%) Past: 49 (49%) Current: 20 (20%)
Alcohol n(%) Never: 7 (10%) Past: 15 (21%) Current: 50 (69%) Missing: 28 (28%)
Radiotherapy dose (Gy) mean (SD): 62.9 (9.1) Radiotherapy duration (wks) mean (SD): 6.2 (1.7) |
N = 47 evaluable
HBO: Oxygen: 30 daily dives at 100% oxygen to a pressure of 2.4 ATA for 80-90 minutes.
chlorhexidine mouthwash and antibiotics |
N = 53 evaluable
None HBO
chlorhexidine mouthwash and antibiotics |
primary outcome: incidence of osteoradionecrosis six months following surgery
Secondary endpoints: grade of osteoradionecrosis (Notani classification), osteoradionecrosis at other time-points, acute symptoms 1 week after surgery, pain and quality of life 3-6-12 months after surgery. |
incidence of ORN at primary endpoint: HBO arm: 3/47 (6.4%) non-HBO arm: 3/53 (5.7%) OR 1.13, P>0.99 (95% CI: 0.14 to 8.92)
no dental extraction: 16 (16%); 1 (6%)case of ORN single extraction during surgery: 17 pts; 2 (11%) cases of ORN multiple extractions: 67 (67%); 3 (4%) cases of ORN. The difference in ORN between extraction status was not statistically significant (p=0.558).
incidence of minor bone spicules (MBS) at the primary endpoint: HBO arm: 5/47 (10%) non-HBO arm: 8/53 (15%) OR 0.67, P=0.5642 (95% CI: 0.16 to 2.55)]
less severe symptoms in the first 7 days after surgery in the HBO arm for: pain (P=0.0458) swelling (P=0.0182) bleeding (P=0.0375) mouth opening (P=0.004) eating (P=0.004)
comfortable at day 8 post-surgery: HBO arm: 65% non-HBO arm: 35% OR 2.79, P=0.038 (95% C.I. 1.01 to 8.05).
Pain was lower in the HBO arm than non-HBO arm at all timepoints.
Quality of Life (QoL): similar, with a marginal advantage for the HBO arm being partly attributable to a slight advantage at baseline. |
Cancer Research UK |
2 high drop-out rate and disparity in drop-out rates between trial arms
"The low incidence of osteoradionecrosis seen makes it unnecessary to recommend HBO for dental extractions or implant placement in the irradiated mandible. These findings are in contrast to a recently published Cochrane review and previous trials reporting rates of ORN (non-HBO) of 14-30%, and challenge a long-established standard of care." |