Damon Clear is the culmination of a comprehensive development effort involving several multi-site in vivo studies, third-party university research and extensive design tests. As part of its development, Damon Clear was evaluated in terms of strength, aesthetics and comfort. This evaluation included the following:
- Three multi-site in vivo clinical trials involving 335 patients and 2,010 Damon Clear brackets. The reported rate of Damon Clear bracket failures decreased from 3% in the first clinical trial to less than 1% in subsequent trials following adoption of proper wire sequence protocols.
- A series of in vitro design verification tests to compare various designs of Damon Clear with In-Ovation C and other Damon brackets. Compared with In-Ovation C, Damon Clear showed up to 70% greater rotational strength, 13% greater torque strength, 13% greater tensile debonding strength, and 57% greater shear debonding strength. Damon Clear slides were less likely to open in error during treatment than In-Ovation C. Compared with the earlier design of Damon Clear used in the first two clinical trials, the final production version of Damon Clear showed 73% greater bracket ear strength and 169% more rotational strength.
- Third-party researchers conducted two in vitro studies to simulate any in vivo wear and evaluate the strength of Damon Clear brackets. Damon Clear experienced no structural wear after one year of simulated in vivo use.
- Two in vitro stain tests were conducted using Damon Clear for up to eight weeks using coffee, mustard and red wine as well as various adhesives and primers from different manufacturers. Damon Clear was resistant to staining.
- An in vivo debonding evaluation compared debonding of Damon Clear brackets with debonding of In-Ovation C brackets. During testing, independent clinical evaluators rated Damon Clear as easier to use than In-Ovation C. Patients rated Damon Clear as more comfortable during debonding than In-Ovation C.