IADR Abstract Archives
Experiences from National Reporting of Adverse Reactions to Dental Biomaterials
Objectives:
For over 20 years, the Norwegian Dental Biomaterials Adverse Reaction Unit has operated a national reporting procedure concerning suspected biologic adverse reactions associated with dental biomaterials. The procedure is based on spontaneous and voluntary reporting from dentists, physicians, and dental hygienists. The reporting form is designed to record all types of adverse reactions with any material. When the product and manufacturer is known, the reporter is encouraged to send information to the manufacturer as well. The objectives are to gain knowledge about material-associated adverse reactions and to monitor changes over time.
Methods:
Adverse reaction reports were registred in a database and analyzed with regard to the types of materials involved using multiple response analysis on a yearly basis. The following categories were analyzed: Dental amalgam, composites and cements, metals and alloys, and materials for short-term and transient use. IBM SPSS (version 21) was used for the statistical calculations.
Results:
From 1993 to the end of 2014, 2231 reports were received. The proportion of reports involving dental amalgam decreased over time from a peak of 89 % in 1994 to 28 % in 2014 (p<0.01). The proportion of the reports related to composites and cements has been relatively stable over the years and in 2014 39 % were related to composites and cements. Reports on materials for short-term and transient use have remained at the 15 % level. The proportion of reports on reactions involving prosthodontic metals and alloys increased from 13 % in 1993 to 43 % in 2014 (p<0.01).
Conclusions:
The Norwegian national manufacturer-independent reporting procedure provides longitudinal data concerning suspected adverse reactions to dental biomaterials. The potential complexity of biologic reactions warrants an assessment by a dedicated adverse reaction unit.
For over 20 years, the Norwegian Dental Biomaterials Adverse Reaction Unit has operated a national reporting procedure concerning suspected biologic adverse reactions associated with dental biomaterials. The procedure is based on spontaneous and voluntary reporting from dentists, physicians, and dental hygienists. The reporting form is designed to record all types of adverse reactions with any material. When the product and manufacturer is known, the reporter is encouraged to send information to the manufacturer as well. The objectives are to gain knowledge about material-associated adverse reactions and to monitor changes over time.
Methods:
Adverse reaction reports were registred in a database and analyzed with regard to the types of materials involved using multiple response analysis on a yearly basis. The following categories were analyzed: Dental amalgam, composites and cements, metals and alloys, and materials for short-term and transient use. IBM SPSS (version 21) was used for the statistical calculations.
Results:
From 1993 to the end of 2014, 2231 reports were received. The proportion of reports involving dental amalgam decreased over time from a peak of 89 % in 1994 to 28 % in 2014 (p<0.01). The proportion of the reports related to composites and cements has been relatively stable over the years and in 2014 39 % were related to composites and cements. Reports on materials for short-term and transient use have remained at the 15 % level. The proportion of reports on reactions involving prosthodontic metals and alloys increased from 13 % in 1993 to 43 % in 2014 (p<0.01).
Conclusions:
The Norwegian national manufacturer-independent reporting procedure provides longitudinal data concerning suspected adverse reactions to dental biomaterials. The potential complexity of biologic reactions warrants an assessment by a dedicated adverse reaction unit.