Hyperbaric oxygen treatment of mandibular osteoradionecrosis: Combined data from the two randomized clinical trials DAHANCA-21 and NWHHT2009-1.

PURPOSE: Osteoradionecrosis (ORN) of the mandible is a serious complication of head and neck radiotherapy. This study aims to investigate the effect of hyperbaric oxygen (HBO) treatment on ORN in two randomized, controlled multicentre trials. METHODS AND MATERIALS: Patients with ORN with indication for surgical treatment were randomised to either group 1: surgical removal of necrotic mandibular bone supplemented by 30 pre- and 10 postoperative HBO exposures at 243 kPa for 90 min each, or group 2: surgical removal of necrotic bone only. Primary outcome was healing of ORN one year after surgery evaluated by a clinically adjusted version of the Common Toxicity Criteria of Adverse Events (CTCAE) v 3.0. Secondary outcomes included xerostomia, unstimulated and stimulated whole salivation rates, trismus, dysphagia, pain, Activities of Daily Living (ADL) and quality of life according to EORTC. Data were combined from two separate trials. Ninety-seven were enrolled and 65 were eligible for the intent-to-treat analysis. The 33% drop-out was equally distributed between groups. RESULTS: In group 1, 70% (21/30) healed compared to 51% (18/35) in group 2. HBO was associated with an increased chance of healing independent of baseline ORN grade or smoking status as well as improved xerostomia, unstimulated whole salivary flow rate, and dysphagia. Due to insufficient recruitment, none of the endpoints reached a statistically significant difference between groups. ADL data could only be obtained from 50 patients. CONCLUSION: Hyperbaric oxygen did not significantly improve the healing outcome of osteoradionecrosis after surgical removal of necrotic bone as compared to standard care (70% vs. 51%). This effect is not statistically significant due to the fact that the study was underpowered and is therefore prone to type II error.

Orthognathic surgery treatment injuries reported to the Danish Patient Compensation Association: A 25-year retrospective observational study.

AIM OF STUDY: The aim of this study was to describe and classify indemnity claims of treatment injuries in orthognathic surgery received by the Danish Patient Compensation Association (DPCA) during a 25-year time span from 1993 to 2018 in order to illustrate the wide scope of treatment injuries, patient's complaints, suffering, and compensation. MATERIAL AND METHODS: All indemnity claims associated with orthognathic surgery were reviewed accessing the DPCA database including osteotomies performed in association with orthodontic treatment only, thus excluding access osteotomies for tumor surgery, osseodistraction cases, etc. RESULTS: A total of 237 indemnity claims were received for injury associated with orthognathic surgery, including anesthesia. One-hundred sixteen claims (49 %) were approved and patients accordingly compensated with a total of 23.2 million, average 200.000 Danish kroner per patient. In US dollars, 3.5 million, and 30 thousand, respectively. Most claims (45.5 %) were associated with neurological issues, neurosensory disturbances of all kinds including pain and loss of neural function. Others were associated with airway, breathing and circulation (2.1 %), temporomandibular joint issues (8.9 %), jaw malposition (9.3 %), malocclusion (11.0 %), facial issues (6.8 %), dental issues (10.5 %), and miscellaneous (5.9 %), as sole complaint or in concert. Data from the Danish Health Data Authority allowed a calculation of the indemnity claims rate covering the time frame 2005-2008 being indeed very low, 1.8 % out of 10,955 orthognathic surgeries. CONCLUSIONS: Treatment injuries do occur to the misfortune of patients and surgeons alike. The low rate of indemnity claims indicates an underreporting when compared to known rates of complications. It is the surgeon's responsibility that potential benefits of surgery outweigh the risk of complications, be they treatment errors or known shortcomings of procedures. Established criteria for admission to orthognathic surgery would be advisable and most probably reduce the number patients operated on marginal indication and hence treatment injuries in this group.

Reconstruction of irradiated mandible after segmental resection of osteoradionecrosis-a technique employing a microvascular latissimus dorsi flap and subsequent particulate iliac bone grafting.

The fibula osteocutaneous flap has revolutionized the options of mandibular segmental defect bridging in osteoradionecrosis (ORN). In selected cases, however, the fibula flap is not an option because of atherosclerosis or other features that compromise the vascularity of the lower leg and foot. The aim of this study is to present an alternative method of mandibular segmental reconstruction employing a latissimus dorsi (LD) flap and subsequent particulate iliac free bone graft reconstruction. In 15 patients with ORN, a mandibular segmental defect was bridged with a reconstruction plate, and the defect site was primed with a LD musculocutaneous flap wrapped around the reconstruction plate to bring in vascularized tissue and optimize healing conditions for a subsequent particulate iliac free bone graft reconstruction. The management of defect closure was successful in all 15 patients. Twelve patients had a subsequent bone grafting from the posterior ileum for repair of defects up to 14 cm length. Three patients had no bone graft for various reasons. In three patients dental rehabilitation was achieved with implant supported prosthodontic appliances. Ten patients met the success criteria of uneventful graft healing with restitution of osseous continuity, mandibular height, symmetry and function, and avoidance of reconstruction plate fracture.

Stimulation of the sphenopalatine ganglion in intractable cluster headache: expert consensus on patient selection and standards of care.

CONTEXT AND OVERVIEW: Chronic cluster headache (CCH) is a debilitating headache disorder with a significant impairment of the patients' lives. Within the past decade, various invasive neuromodulatory approaches have been proposed for the treatment of CCH refractory to standard preventive drug, but only very few randomized controlled studies exist in the field of neuromodulation for the treatment of drug-refractory headaches. Based on the prominent role of the cranial parasympathetic system in acute cluster headache attacks, high-frequency sphenopalatine ganglion (SPG) stimulation has been shown to abort ongoing attacks in some patients in a first small study. As preventive effects of SPG-stimulation have been suggested and the rate of long-term side effects was moderate, SPG stimulation appears to be a promising new treatment strategy. AIMS AND CONCLUSION: As SPG stimulation is effective in some patients and the first commercially available CE-marked SPG neurostimulator system has been introduced for cluster headache, patient selection and care should be standardized to ensure maximal efficacy and safety. As only limited data have been published on SPG stimulation, standards of care based on expert consensus are proposed to ensure homogeneous patient selection and treatment across international headache centres. Given that SPG stimulation is still a novel approach, all expert-based consensus on patient selection and standards of care should be re-reviewed when more long-term data are available.

Association between third mandibular molar impaction and degree of root development in adolescents.

OBJECTIVE: To compare the root development and the growth rate of the mandibular third molar (M3 inf) in individuals where the M3 inf erupted vs individuals exhibiting M3 inf impaction. MATERIALS AND METHODS: Serial standardized intraoral radiographs (Eggen technique) were taken annually of the mandibular third molar region from 132 subjects (71 male and 61 female) from 15 to 20 years of age. Based on the films, 264 lower third molars were classified into an eruption and an impaction group. Root development was recorded according to a quantitative method described by Haavikko (1970), and the eruption status was analyzed using logistic regression. RESULTS: In total, 155 (59%) of the M3 inf erupted, and 109 (41%) were impacted at age 20. In 44 (33%) patients both M3 inf were impacted, in 21 (16%) patients one tooth was erupted and the contralateral tooth impacted, and in 67 (51%) patients both M3 inf were erupted. The more mature a tooth was at age 15, the higher was the probability of eruption (odds ratio: 3.89, P < .001). The growth rate of the root development stage was statistically significantly associated with the probability of eruption (odds ratio: 10.50, P  =  .041). CONCLUSIONS: Delayed mandibular third molar root development is associated with impaction. Radiographs taken at age 15 may predict the risk of impaction and thereby guide decision making for the orthodontist or the oral and maxillofacial surgeon.

Trigeminal nerve injury associated with injection of local anesthetics: needle lesion or neurotoxicity?

BACKGROUND: The authors used comprehensive national registry and clinical data to conduct a study of adverse drug reactions (ADRs), in particular neurosensory disturbance (NSD), associated with local anesthetics used in dentistry METHODS: The study included data sets of annual sales of local anesthetics (from 1995 through 2007), 292 reports to the Danish Medicines Agency, Copenhagen, Denmark, of adverse reactions to local anesthetic drugs, and a clinical sample of 115 patients with NSD associated with local anesthetics. The authors assessed lidocaine 2 percent, mepivacaine 2 percent and 3 percent, prilocaine 3 percent, and articaine 4 percent sold in cartridges. RESULTS: The study results showed a highly significant overrepresentation of NSDs associated with articaine 4 percent, in particular with mandibular blocks. CONCLUSIONS: The distribution of NSDs was disproportionate to the market share of three of the four drugs in both national registry data and clinical data. These findings indicate that the main cause of injury was neurotoxicity resulting from administration of the local anesthetic rather than the needle penetration. CLINICAL IMPLICATIONS: Clinicians may consider avoiding use of high-concentration (4 percent) anesthetic formulations for block anesthesia in the trigeminal area in cases in which there are viable alternatives.

Does hyperbaric oxygen treatment have the potential to increase salivary flow rate and reduce xerostomia in previously irradiated head and neck cancer patients? A pilot study.

Irradiated head and neck cancer survivors treated in the Hyperbaric Oxygen (HBO) Unit, Copenhagen University Hospital, spontaneously reported improvement of radiation-induced dry mouth feeling. The aim of this pilot study was to evaluate salivary flow rate and xerostomia before and after HBO in irradiated head and neck cancer patients. Eighty patients eligible for HBO treatment on the indication of prevention/treatment of osteoradionecrosis or soft tissue radiation injury were consecutively sampled, of whom 45 had hyposalivation (i.e. unstimulated whole saliva (UWS) flow rate <0.1ml/min), and 69 complained of xerostomia. UWS and stimulated whole saliva (SWS) were collected prior to and after 30 sessions of hyperbaric oxygen treatment over 6weeks. Xerostomia was assessed using the visual analogue scale (VAS). Each HBO session involved compression to 243kPa (2.4 ATA) for 90min while breathing 100% oxygen from a facemask or hood. There was a significant decrease in xerostomia (p<0.001) and slight increase in UWS (p<0.001) and SWS (p<0.001) flow rate, from before HBO as compared to after. Twenty-five of 45 patients with hyposalivation achieved an increased UWS flow rate after HBO. In 12 of these, the flow rates increased to levels not associated with hyposalivation. Patient-assessed improvement of xerostomia and slightly increased UWS and SWS secretion after HBO treatment suggest that HBO may have a beneficial effect on radiation-induced salivary gland damage.

Concentration-dependent neurotoxicity of articaine: an electrophysiological and stereological study of the rat sciatic nerve.

BACKGROUND: We performed this study to quantify the detrimental effect of intraneural injection of 50 µL of saline, articaine 2%, or articaine 4% in the rat sciatic nerve. METHODS: Lumbar-evoked electrospinograms from stimulation of the sciatic nerve were recorded before and immediately after injection and again after 3 weeks. Test substance was injected into the right sciatic nerve, and the untreated left sciatic nerve served as control. The animals were killed after the 3-week follow-up, and cross-sections of the sciatic nerve were examined stereologically. RESULTS: The evoked spinal cord field potential in the articaine groups faded away immediately after injection and was concentration-dependently, significantly more reduced at the 3-week follow-up in comparison with the saline group. The response from the control sides was unaffected in all groups. The number of myelinated axons was unaffected by the treatment. The mean cross-sectional axon area and the mean myelin sheath thickness were significantly reduced in animals injected with articaine 4%. CONCLUSIONS: These observations indicate concentration-dependent neurotoxic injuries after injection of articaine with a significant difference between 2% and 4% formulations. The mechanical injury of needle penetration with saline injection had no significant effect on nerve conduction or histomorphology.

Open or closed repositioning of mandibular fractures: is there a difference in healing outcome? A systematic review.

The clinical outcome of closed vs open reduction and rigid fixation was compared based on a systematic review of the literature. Ten non-randomized retrospective studies were found. In six of these ten studies, the complication rate was significantly increased when open reduction and plating was performed. In the remaining studies, a slightly elevated (but not significant) infection rate was found when compared with closed reduction. Altogether, an infection rate of 5.0% was found in the closed reduction group whereas 10.6% and 14.6% were found when open reduction was performed using either plates or wires. Nerve injuries were slightly increased when open reduction was found (although not significant). With regard to occlusal disturbances, no difference was found in the open and closed reduction group. Concerning overall complication problems, six of seven studies showed more problems after open than closed reduction. In conclusion, this literature review using retrospective studies has raised doubts regarding the superiority of open reduction and rigid splinting, compared to closed reduction and intermaxillary splinting. However, a bias concerning the preferential use of open reduction in case of more complicated fractures cannot be excluded, which might explain the differences found between the two procedures. Prospective, randomized clinical trials are needed to illuminate this problem.

Effect of early or delayed treatment upon healing of mandibular fractures: a systematic literature review.

The possible relation between treatment delay and healing complications in mandibular fracture treatment (excluding condylar fractures) was reviewed systematically. Twenty-two studies were identified. No randomized studies focused on the effect of immediate or delayed treatment. The main focus of most studies was surgical repositioning and internal skeletal fixation. The healing complications analyzed in this study were infection in the fracture line and malocclusion. Statistical analysis of the influence of treatment delay upon healing complications was possible in six studies. Four studies showed no significant difference between immediate and delayed treatment. One study showed a preference for healing for cases treated within 3 days, whereas another study indicated that treatment time between 3 and 5 days were optimal with the lowest rate of complications. Finally, a few studies identified confounding factors such as alcohol, drug abuse and/or non-compliance, factors which have been shown strongly to influence the likelihood of complications. A significant problem in this analysis was that rather few patients were actually treated on an acute basis (i.e. within 12 or 24 hours after injury), a fact which together with the lack of control of confounding factors made this analysis problematic. In conclusion, there is presently no strong evidence for either acute or delayed treatment of mandibular fractures in order to minimize healing complications; new studies including a substantial number of cases treated on an acute basis are very much needed.

Iatrogenic injury to oral branches of the trigeminal nerve: records of 449 cases.

The aims of this study were threefold: (1) to describe iatrogenic lesions to oral branches of the trigeminal nerve, signs and symptoms, and functional status, (2) to report on a simple neurosensory examination method, and (3) to discuss means of prevention of iatrogenic injury. The etiology and functional status of 449 injuries to oral branches collected over 18 years were retrospectively reviewed. A simple scheme of a clinical neurosensory examination was applied to enable a quantified rating of the perception. Injury to the lingual nerve (n = 261) is not only the most prevalent type of lesion, it also seems to be the most devastating type of lesion. Third molar surgery (n = 319) counts for the majority of injuries to the lingual, inferior alveolar, and buccal nerves. Lesions related to the injection of local analgesics was the second most frequent etiology (n = 78), and the lingual nerve was affected more frequently and severely than other oral branches of the trigeminal nerve. The female gender was overrepresented in incidence of injured nerves but no difference was found in the severity of affection between females and males. All grades of loss of neurosensory functions were found, and a range of neurogenic malfunctions was reported. Methodological obstacles in clinical neurosensory examination of trigeminal nerve injury and the magnitude of neurosensory impairment are discussed. Many nerve injuries are avoidable by critical reevaluation of indications, increased awareness of potential hazards, and modified surgical procedures.