An Investigation into the Use of a Single Component Self-etching Primer Adhesive System for Orthodontic Bonding: a randomized controlled clinical trial

Objective: This study assessed the in vivo bond failure of the single component orthodontic self-etching primer system, Ideal 1 (GAC Orthodontic Products) and compared it with the conventional acid etching using a conventional 37% o-phosphoric acid, rinsing and drying regimen when bonding stainless steel orthodontic brackets to enamel. Design: Prospective randomized, controlled clinical trial. Setting: Orthodontic Department, Bristol Dental School. Material and methods: Twenty consecutive patients undergoing upper and lower fixed orthodontic treatment entered this cross-mouth control study. Diagonally opposite quadrants were randomly allocated to either the self-etching primer group or the conventional etching group. A total of 339 teeth were bonded with Ideal 1 light-cured adhesive. Bond failures and locus of bond failure were then recorded at 1, 6 and 12 months. Results: Significantly more bond failures occurred at each of the 3 time intervals, 1, 6 and 12 months, where the enamel was pretreated with the Ideal I self-etching primer, than when the enamel was treated with the conventional etchant, 37% o-phosphoric acid. With the latter the cumulative bond failure rates were 3.0, 5.3 and 14.8%, respectively. With the self-etching primer the cumulative failure rates were 29.4, 56.5 and 72.4%. Conclusion: The study found that enamel pre-treatment with the Ideal 1 self-etching primer system prior to orthodontic bonding results in an unacceptably high bond failure rate when compared with conventional enamel acid etching.