Question
Our daughter (10) has to wear a soft positioner (position trainer for misaligned teeth) for an hour a day and at night to sleep. As we keep reading about harmful plasticizers, I am worried. Although I can hardly imagine that a dental practice would dispense materials that are harmful to health, I am unsure because our daughter chews on the trainer from time to time while she sleeps and small parts come loose. Can swallowing these parts or wearing the trainer for long periods of time damage her health?
Short answer
A special EU regulation, which Switzerland has joined, defines the basic requirements for medical devices in order to protect patients as well as manufacturers and users from undesirable effects. As the positioner bears this CE marking, it can be assumed that it can be worn without hesitation.
In principle, all medical products, including dental materials, must meet the requirements of EU Directive 93/42 EEC. This directive came into force around 10 years ago and has proven its worth. Switzerland has also signed up to this EU regulation. It lays down the basic requirements for medical devices with the aim of protecting patients, manufacturers (e.g. employees in production facilities) and users (e.g. dentists, speech therapists) from undesirable effects.
Detailed tests
The materials are therefore tested for their toxic and sensitizing effects in biological tests. Responsible manufacturers will only release the materials once these tests have been successfully completed, the risk analysis has not revealed any unacceptable risks and the materials meet all applicable standards. The group of dental materials and devices is one of the best standardized areas.
The manufacturer may then award the CE mark, which is affixed to the product or packaging. The CE mark is familiar to us from toys or electrical appliances and can be seen as a seal of quality that the product has been tested and meets the relevant standards and promised performance.
In the specific case of the Position Trainer, CE marking is present. It can therefore be assumed that the positioner can be worn without hesitation. As the material of the Position Trainer consists of silicone and a rubber-elastic mass, it can also be assumed that the possibility of developing an allergy can be neglected. Incidentally, if there were no CE marking, the manufacturing company and the prescribing therapist would be liable to prosecution.
Monitoring obligation
The manufacturer must also monitor the products after sale and maintain a reporting system in which every problem with the product that comes to its attention is registered and evaluated in order to discover any previously unknown risks or to incorporate a higher level of safety in further development. If there is a serious threat, the product must be recalled (this sometimes happens with toys).
Author: Dr. med. dent. Jürg Eppenberger
Appearance in: Neue Luzerner Zeitung on January 14, 2009