Reporting on adverse reactions to dental materials--intraoral observations at a clinical follow-up.
OBJECTIVE
A national reporting system designed to monitor adverse reactions to dental materials was established in Norway in 1993. The activities have also included clinical examination of patients with suspected reactions to dental materials. The ongoing activities are coordinated by the Dental Biomaterials Adverse Reaction Unit at the University of Bergen. The reporting procedure is based on voluntary spontaneous reporting by dentists and physicians. The reports could be based on subjective symptoms or objective findings, or both. The aim of the present study was to compare reported objective intraoral findings with those found during examination at the unit.


METHODS
Reported reactions were compared with clinical findings obtained following dental and medical examination at the unit. From 1993 to 1999, a total of 899 reports were received while 253 patients were referred and examined at the unit.


RESULTS
The reports on patients who were examined at the unit involved mainly reactions related to amalgam fillings (84%), metals in fixed dentures (11%), resin-based materials and cements (4%), materials used in removable dentures (2%), and endodontic materials (2%). Edema, lichenoid reactions, ulcers/vesicles, erythema, and atrophy were found in 80 patients during the examination at the unit. For 35 of these patients, the intraoral findings at the unit were also given in the reports. For another 45 patients, objective intraoral signs of reactions were found upon examination at the unit, but these findings had not been reported.


CONCLUSIONS
A spontaneous reporting system is a cost-effective method for monitoring intraoral reactions associated with dental materials. Considering the increasing number and complexity of these materials, there appears to be a need for continuous validation of reports by a speciality unit. In order to receive more accurate information about the adverse reactions, it would be advisable that the reporting forms include more detailed guidance regarding signs of reactions that practitioners should be on the look out for and consider.
Lygre
Gunvor Bentung
GB
Dental Biomaterials Adverse Reaction Unit, University of Bergen, Norway. Gunvor.Lygre@odont.uib.no
Gjerdet
Nils Roar
NR
Grønningsaeter
Arne Geir
AG
Björkman
Lars
L
D000328:Adult; D016907:Adverse Drug Reaction Reporting Systems / Q000458:organization & administration; D000368:Aged; D001284:Atrophy; D003188:Composite Resins / Q000009:adverse effects; D003722:Dental Alloys / Q000009:adverse effects; D003723:Dental Amalgam / Q000009:adverse effects; D003764:Dental Materials / Q000009:adverse effects*; D003793:Dental Restoration, Permanent / Q000009:adverse effects; D003778:Dentures / Q000009:adverse effects; D004487:Edema / Q000139:chemically induced; D004890:Erythema / Q000139:chemically induced; D005260:Female; D006801:Humans; D017512:Lichenoid Eruptions / Q000139:chemically induced; D008297:Male; D008875:Middle Aged; D009059:Mouth Diseases / Q000139:chemically induced; D009664:Norway; D019226:Oral Ulcer / Q000139:chemically induced; D019279:Resin Cements / Q000009:adverse effects; D012387:Root Canal Filling Materials / Q000009:adverse effects
D003188:Composite Resins; D003722:Dental Alloys; D003764:Dental Materials; D019279:Resin Cements; D012387:Root Canal Filling Materials; D003723:Dental Amalgam