Bone Necrosis after Devigen™ Application: A Case Report and Medico-Legal Discussion

Objectives: Paraformaldehyde compounds are extremely toxic to teeth and surrounding tissues. The literature has reported several cases of damage to soft and hard tissues caused by the leakage or spread of the devitalising toxic compounds away from the dental filling, such as bone or gum necrosis, paraesthesia due to toxic nerve damage and allergic responses and important scientific Society of Endodontology (American Association of Endodontists and the European Society of Endodontology ) recommended against their use.

Methods: This report describes a case of bone necrosis after an inappropriate off-label use of paraformaldehyde-containing paste and the connected breach of the duty of care owed to the patient.

Results: Patients is still in follow-up since she is waiting for a compensation.

Conclusions: Dentists should be aware of the severe risks to patient health of the use of aldehyde paste in endodontic practice and of the medico-legal consequences of such sub-standard procedures. The clinical and medico-legal issues of the reported case support the sale dismission of such toxic materials and the discontinuation of their use by endodontic practitioners.

Clinical significance statement: Paraformaldehyde compounds are extremely toxic to teeth and surrounding tissues. We strongly believe that use of such toxic materials should be banned everywhere and we present the main medico-legal issues connected with their use.