This double-blind split-mouth trial with 16 adult patients investigated the ability of a dentine bonding agent (DBA) to reduce cervical dentine sensitivity. Following stimulation of pairs of teeth by conventional tactile and air blast stimuli, together with controlled evaporative and cold fluid stimuli, sensitivity was recorded using tactile threshold, visual-analogue scale (VAS) and short-form McGill pain questionnaire (SFMPQ), prior to and 1 week following treatment with DBA. Prior to assessment, subjects recorded their perceived overall sensitivity using VAS and SFMPQ. Application of each stimulus was separated by 10 min. Sensitivity was recorded by a clinician blinded to the treatment status of each tooth. The control tooth was treated by applying DBA to coronal enamel. Dietary information was collected after the post-treatment assessment. There was a significant (p<0.05) improvement in tactile threshold and air flow and air blast VAS scores, together with reductions in sensitivity to evaporative stimuli when assessed by SFMPQ. Treatment response was not influenced by the subjects' age, gender, diet, use of fluoride-containing or silica-based toothpastes or fluoride mouthwashes, or a history of previous sensitivity treatment. It is concluded that topical application of DBA is an effective way to reduce cervical dentine sensitivity.
This underestimated adverse drug reaction is a class effect, time to onset is most often less than 1 year and outcome seems favorable after ARB discontinuation. The case/non-case approach highlights a potential safety signal. The SmPC of ARBs should be updated, increased awareness among healthcare professionals is warranted.
The aim of this study was to describe bisphosphonate-related osteonecrosis of the jaw (BRONJ) in the French national pharmacovigilance database. BRONJ was identified with the standardized MedDRA query (SMQ) 'osteonecrosis' among all data from 1985 to 31 December 2014. Because this SMQ was not specific to the jaw localization, selection of cases based on anatomy was performed after data extraction. For each case, demographic and medical information was analysed, as well as data about notification (year of notification, year of occurrence, outcome, seriousness). Known associated factors for BRONJ were also documented: dentoalveolar surgery, glucocorticoids, chemotherapy, anti-angiogenics, denosumab. Among 1404 SMQ notifications, 663 were located in the jaws and 629 were associated with bisphosphonate use. BRONJ reported in the database mainly affected women (n = 443, 71%) with an oncological indication (n = 440, 70%). BRONJ was considered as serious in 91%. Outcome was unfavourable for 92% of cases. Associated factors were identified for 70% of the patients. A peak of notification was noted in 2014 (13% of all cases), but on analysis by year of occurrence instead of by year of notification, this peak disappeared. SMQ 'osteonecrosis' appears to be an adequate tool to analyse BRONJ in a pharmacovigilance database.
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