Hyperbaric Oxygen Therapy for Radionecrosis of the Jaw: A Randomized, Placebo-Controlled, Double-Blind Trial From the ORN96 Study Group

Annane, Djillali; Depondt, J; Aubert, P; Villart, M.; Géhanno, P.; Gajdos, Philippe; Chevret, Sylvie

doi:10.1200/jco.2004.09.006

Cited by 315 publications

(243 citation statements)

References 17 publications

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“…The characteristics of the selected trials are summarised below (see also Table 3). In terms of experimental design, the majority [17][18][19][20][21][22][23][24][25][26][27][28][29] were conventional parallel trials with either two or three treatment arms. In addition, there were some [30][31][32] split-mouth trials.…”

Section: Resultsmentioning

confidence: 99%

“…The authors acknowledge that sequential methods may not always be appropriate for all dental trials. There were eight trials 19,25,26,[30][31][32][33][34] employing graphical methods. The procedures were successful in all cases, with no trials discontinued for lack of conclusiveness.…”

Section: Present Resultsmentioning

confidence: 99%

“…It was found that, of the trials that used sequential analysis, six 25,[30][31][32][33][34] were fully sequential and five 18,19,22,24,28 were group sequential. The fully sequential trials were all graphical.…”

Section: Present Resultsmentioning

confidence: 99%

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Sequential analysis applied to clinical trials in dentistry: a systematic review

Bogowicz¹,

Flores-Mir²,

Major³

et al. 2008

Evid Based Dent

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Clinical trials employ sequential analysis for the ethical and economic benefits it brings. In dentistry, as in other fields, resources are scarce and efforts are made to ensure that patients are treated ethically. The objective of this systematic review was to characterise the use of sequential analysis for clinical trials in dentistry. We searched various databases from 1900 through to January 2008. Articles were selected for review if they were clinical trials in the field of dentistry that had applied some form of sequential analysis. Selection was carried out independently by two of the authors. We included 18 trials from various specialties, which involved many different interventions. We conclude that sequential analysis seems to be underused in this field but that there are sufficient methodological resources in place for future applications.www.nature.com/ebd

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Section: Resultsmentioning

confidence: 99%

Section: Present Resultsmentioning

confidence: 99%

See 1 more Smart Citation

Sequential analysis applied to clinical trials in dentistry: a systematic review

Bogowicz¹,

Flores-Mir²,

Major³

et al. 2008

Evid Based Dent

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show abstract

“…Cette indication est internationalement reconnue mais elle demeure largement contestée [81][82][83][84].…”

Section: Discussionunclassified

Intérêt de l’oxygénothérapie hyperbare dans l’optimisation de la cicatrisation osseuse en odontostomatologie

Gunepin

Derache

Pêcheur

et al. 2013

Med Buccale Chir Buccale

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Résumé -En odontostomatologie, face à une perte de substance osseuse dont le comblement ne peut intervenir spontanément du fait des seules capacités physiologiques du patient (défaut osseux de taille critique), le praticien peut avoir recours à de nombreux matériaux de comblement osseux. Actuellement, le matériau de référence reste l'os du patient (greffe autogène). Cependant, pour des raisons liées parfois au manque de disponibilité de cet os et/ou à la morbidité potentielle accompagnant la création d'un second site opératoire, le praticien peut avoir recours à de l'os allogène (provenant d'un autre patient), de l'os xénogène (d'origine animal) ou à des matériaux de substitution osseuse d'origine naturelle ou synthétique. La correction de ces défauts osseux pouvant être essentielle en odontostomatologie (prévention de la survenue de fracture, possibilité d'entreprendre ultérieurement des traitements implantaires et prothétiques et préservation de l'esthétique), de nombreux auteurs ont étudié différentes techniques visant à optimiser le processus de cicatrisation osseuse. Dès les années 1960, l'oxygénothérapie hyperbare ou OHB a été proposée comme traitement adjuvant de la cicatrisation osseuse. L'OHB consiste en l'administration d'oxygène pur à un patient à une pression supérieure à celle du niveau de la mer. Actuellement il n'existe aucune preuve de l'efficacité ou de l'inefficacité de l'OHB sur la cicatrisation osseuse. Ceci s'explique par le manque de connaissance des mécanismes exacts de l'action de l'OHB sur le tissu osseux et sur l'absence de larges essais cliniques contrôlés randomisés. L'analyse de la littérature met cependant en exergue le fait que si l'OHB ne doit pas être utilisée systématiquement, son recours peut être envisagé en fonction de la lésion, du patient, du type de greffe réalisé et/ou du type de substitut osseux utilisé.Abstract -Interest of hyperbaric oxygen therapy in the optimization of bone healing in odontostomatology.

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“…30 However, more recent studies have questioned HBO's benefi t. In a randomised double-blind trial of patients with ORN treated with either HBO or a placebo, no benefi t was seen in the group undergoing hyperbaric oxygenation. 31 Further to this, oral implant rehabilitation of irradiated patients has been shown to be successful without adjunctive hyperbaric oxygen.…”

Section: Introductionmentioning

confidence: 97%

A national survey of oral and maxillofacial surgeons' attitudes towards the treatment and dental rehabilitation of oral cancer patients

et al. 2009

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Hyperbaric Oxygen Therapy for Radionecrosis of the Jaw: A Randomized, Placebo-Controlled, Double-Blind Trial From the ORN96 Study Group

Abstract: Patients with overt mandibular osteoradionecrosis did not benefit from hyperbaric oxygenation.

Cited by 315 publications

References 17 publications

Sequential analysis applied to clinical trials in dentistry: a systematic review

Sequential analysis applied to clinical trials in dentistry: a systematic review

Intérêt de l’oxygénothérapie hyperbare dans l’optimisation de la cicatrisation osseuse en odontostomatologie

A national survey of oral and maxillofacial surgeons' attitudes towards the treatment and dental rehabilitation of oral cancer patients

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