Nytt regelverk för medicintekniska produkter i tandvården

Source at https://www.tandlakartidningen.se/vetenskaplig-artikel/nytt-regelverk-for-medicintekniska-produkter-i-tandvarden/Den 26 maj började det nya direktivet för medicintekniska produkter inom tandvården att gälla fullt ut. Fokus ligger främst på krav på uppdaterad dokumentation och riskanalys samt förbättrad spårbarhet

Drømmen om nye tenner

Source at https://www.tannlegetidende.no/journal/2021/3/m-838/Dr%C3%B8mmen_om_nye_tenner.Tannlegene vært opptatt av muligheten for å få dannet nye tenner lenge. Det har ført til et nøye studium av den embryonale tann- dannelsen for å kunne kopiere den eksperimentelt. Forskningen har imidlertid bare i liten grad kunnet anvende sine eksperimen- telle oppsett på mennesker, men har benyttet seg av dyr som mus, rotter, minigriser og hunder, enkelte ganger i kombinasjon med in vitro oppdyrking av bestemte celler. Med utgangspunkt i stamcel- ler både fra tannrelatert vev eller fra fettvev og benmarg, har man kunnet få utviklet nytt pulpavev eller rothinne med cement og fi- bre. På mus har man også fått en helt ny tannkim til å utvikle seg ved å transplantere de relevante cellene til en tom sokkel. Detalj- kunnskapen om rollen til celler og signalstoffer ved tanndannelse har økt betydelig gjennom de siste årene, men det er vanskelig å se at mulighetene for å utvikle nye humane tenner er kommet nærmere. Kanskje kan det ligge en viss gevinst i regenerasjon av pulpa og periodontalt vev.The dental community has for a long time been fascinated by the thought of growing a third set of teeth. This has increased re - search interest in the processes of embryonal development of teeth for experimental copying. However, research of this kind cannot be performed on humans for medical and ethical reasons. The researchers have used animals such as mice, rats, minipigs, dogs etc., sometimes in combination with in vitro cultivation of cell populations containing stem cells. With stem cells from different lo- cations, pulp tissue and periodontal tissues such as cement and fib- ers have been developed. In mice, whole tooth germs could be grown after transplanting the relevant cells to an empty socket. On the basis of the research reports cited here it is difficult to see that the possibilities of developing new human teeth are bet - ter than before the stem cell revolution, although there might be a clinical gain in the techniques for regeneration of pulpal and periodontal tissues

SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks) Opinion on The safety of the use of bisphenol A in medical devices

SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks), Safety of the use of bisphenol A in medical devices, 18 February 2015Testai, Emanuela; Hartemann, Philippe; Rodríguez-Farré, Eduard; Rastogi, Suresh Chandra; de Jong, Wim; Bustos, Juana; Castle, Laurence; Gundert-Remy, Ursula; Hensten, Arne; Kopperud, Hilde Molvig; Olea, Nicolás; Piersma, Aldert; SCENIHR (Scientific Committee on Emerging and Newly Identified Health Risks). The Safety of the use of Bisphenol A in medical devices. [S.l.]: European Commission, 2015. 166 p. ISSN 1831-4783 . ISBN 978-92-79-30133-9 . DOI Doi: 10.2772/75546This opinion assesses whether the use of bisphenol A in medical devices such as implants, catheters, and dental devices could give reasons for safety concerns, to provide indications on limit values for BPA release from medical devices and to identify any patient group, e.g. infants, pregnant and breastfeeding women who would be particularly at risk. Several exposure scenarios have been evaluated taking into account the material used, information related to BPA leaching, the duration of a single treatment and the frequency of treatments, giving rise to toxicologically relevant acute, short and long term exposure. The SCENIHR concludes that risk for adverse effects of BPA may exist when the BPA is directly available for systemic exposure after non-oral exposure routes, especially for neonates in intensive care units, infants undergoing prolonged medical procedures and for dialysis patients. Although the benefit of medical devices has also to be considered, the SCENIHR recommends that, where practicable, medical devices that do not leach BPA should be used. The possibility of replacing BPA in these products should be considered against their efficiency in the treatment, as well as the toxicological profile of the alternative materials. However, better data on exposure would be beneficial for the refinement of the present risk assessment, to be carried out when new data on exposure via medical devices will be available.Peer Reviewe

Nytt regelverk för medicintekniska produkter i tandvården

Den 26 maj började det nya direktivet för medicintekniska produkter inom tandvården att gälla fullt ut. Fokus ligger främst på krav på uppdaterad dokumentation och riskanalys samt förbättrad spårbarhet

Réactions biologiques indésirables des patients et pathologies professionnelles en orthodontie

L'exercice de l'orthodontie amène des biomatériaux exogènes de différentes compositions au contact de la muqueuse ou de la peau. Le processus de vieillissement des matériaux conduit à la libération de petites quantités d'ions métalliques ou de composés organiques à partir des appareils. La concentration des substances libérées est trop faible pour être toxique, sauf si une exposition répétée est associée à une irritation mécanique. Cependant, les réactions allergiques représentent un risque chez les patients préalablement sensibilisés à une substance allergisante particulière. Les réactions sont essentiellement des éruptions cutanées ou des lésions muqueuses, leur incidence a été évaluée entre 0,3 et 0,4 % chez les patients suivis en orthodontie. L'autre aspect de ces réactions indésirables est le risque pour le personnel, exposé de manière répétée à des facteurs similaires, de développer des pathologies. Le risque est plus élevé chez les professionnels que chez les patients. La plupart de ces manifestations sont des dermatoses, leur incidence a été évaluée à environ 20%. Une faible partie de ces maladies professionnelles est constituée de réactions autres que cutanées, telles que des affections respiratoires, des nausées ou des maux de tête, mais la difficulté est de les différencier des problèmes liés au stress ou à l'environnement intérieur

Drømmen om nye tenner

Tannlegene vært opptatt av muligheten for å få dannet nye tenner lenge. Det har ført til et nøye studium av den embryonale tann- dannelsen for å kunne kopiere den eksperimentelt. Forskningen har imidlertid bare i liten grad kunnet anvende sine eksperimen- telle oppsett på mennesker, men har benyttet seg av dyr som mus, rotter, minigriser og hunder, enkelte ganger i kombinasjon med in vitro oppdyrking av bestemte celler. Med utgangspunkt i stamcel- ler både fra tannrelatert vev eller fra fettvev og benmarg, har man kunnet få utviklet nytt pulpavev eller rothinne med cement og fi- bre. På mus har man også fått en helt ny tannkim til å utvikle seg ved å transplantere de relevante cellene til en tom sokkel. Detalj- kunnskapen om rollen til celler og signalstoffer ved tanndannelse har økt betydelig gjennom de siste årene, men det er vanskelig å se at mulighetene for å utvikle nye humane tenner er kommet nærmere. Kanskje kan det ligge en viss gevinst i regenerasjon av pulpa og periodontalt vev

Dog-assisted therapy in the dental clinic: Part A - Hazards and assessment of potential risks to the health and safety of humans

Background - Dog‐assisted therapy in the dental clinic may be an attractive alternative to sedation for anxious patients. Including a dental therapy dog in a clinical setting introduces new hazards and potential risks to health and safety for both humans and animal. Objectives - The study aims to describe potential hazards associated with risks to humans by having a therapy dog present in the dental clinic and to provide guidance on best practices to minimise and control risks for the patients, the dentist, and the dental clinic staff. Materials and Methods - Literature searches in Medline, Clinicaltrials.gov, and Google Scholar for qualitative and quantitative assessments of hazards and risks associated with the use of therapy dogs in health care settings, in combination with a review of the reference list of the included studies. Identified hazards and risks were analysed with respect for the health and welfare of humans in a dental clinic setting that involves the presence of a therapy dog. Results - Potential risks to health and safety for humans in dental clinics that offer dog‐assisted therapy can be categorised within four general categories of hazards: the dog as a source of zoonotic pathogens and human diseases, exposure to canine allergens, adverse animal behaviour, and dangers associated with high activity in a congested dental clinic operatory. Risks to humans are reduced by maintaining awareness amongst the dental clinic staff and the dog handler of all potential hazards in the dental clinic, and on how to reduce these hazards as well as adverse events that may scare the dental therapy dog. Conclusions - Risks to the health and safety of humans in the presence of therapy dog in the clinics are present but are low if the dental clinical staff and dog handlers comply with best practices