OrVance LLC, Grand Rapids, Mich, developer of OrthoDots CLEAR, a dental wax alternative, has published a white paper directed at consumers to alert them about the dental wax that is still commonly dispensed to patients in orthodontic treatment. The company asserts that the generic dental wax dispensed to patients during orthodontic treatment violates current healthcare product quality standards and regulatory requirements.
According to Mike Silver, PhD, OrVance’s director of R&D and technical affairs, “Traditional dental wax is not only obsolete in performance and aesthetics, but it is the last commonly dispensed product in healthcare that has not kept current with several globally accepted quality standards that have been in place for decades. Dental wax comes in contact with saliva, blood, and is occasionally swallowed, so we believe continuing to ignore these quality standards is unacceptable.”
The paper explains four basic quality and safety features that are lacking with generic dental wax and why OrVance has invested to be the first to meet these standards with its OrthoDots CLEAR product. The four missing features are hygienic packaging, tamper-evident packaging, labeling with product traceability, and disclosure of ingredients. According to the company, in a recent survey it conducted of orthodontic residents in the United States, a majority of residents surveyed believe it is not acceptable to dispense a dental wax product to their patients without these quality and safety features.
“We started this consumer awareness campaign because patients and parents need to know about the importance of these quality features as it relates to products used during orthodontic treatment. Now that we finally brought orthodontic wax into compliance with current quality standards, we are encouraging patients and parents to ask their orthodontist for OrthoDots CLEAR instead of generic wax,” said Ron Schutt, OrVance’s CEO. “Over the last 18 months we’ve worked hard to educate orthodontic product suppliers, orthodontists, and resident programs about the importance of these quality and safety features. Since most suppliers to the orthodontic profession continue to ignore the issues with dental wax, we are now expanding our focus to educate patients and parents.”
Schutt continued, “The responsibility for product quality and compliance is with the manufacturers and suppliers to the orthodontic industry, so orthodontists have rightfully assumed that the products they purchase for their practice meet basic quality standards. But to most suppliers, generic dental wax is perceived to be OK to sell only because everyone else is still selling it. We have notified over 30 orthodontic product suppliers about the quality and compliance issues with generic dental wax and have received no credible denial or pushback. Yet most suppliers to the orthodontic profession continue to ignore these deficiencies. As we believe this is a critical issue for patient safety and for the integrity of the orthodontic profession, we fully intend to escalate our advocacy efforts until all orthodontic wax is fully compliant with current healthcare product standards.”
In a letter to the American Association of Orthodontists, OrVance stated, “We believe it unfair that OrthoDots CLEAR must compete on price with a product that avoids the costs of current quality and regulatory requirements. Even putting aside the performance and aesthetic benefits of OrthoDots CLEAR, is it really worth saving only $1 to $2 per patient to dispense an inferior product that knowingly violates current quality and regulatory requirements? Generic dental wax is in clear violation of longstanding regulations within the EU as well as globally accepted healthcare quality and safety standards.”
Mart McClellan, DDS, MS, an orthodontist and author who serves as an advisor to the company, added, “Scrutiny of our profession is certain to increase if we continue to ignore the noncompliance and poor performance of the most commonly dispensed product in our profession. Now that we finally have a solution, we need more urgency within our profession to address this quality issue for the benefit of our patients.”
The full whitepaper can be found at orvance.com.