A Prospective Randomized Clinical Trial to Compare Pre-coated and Non-pre-coated Brackets

Abstract

Objective: To compare the clinical failure rate of pre-coated brackets and brackets bonded using Transbond XT light cure system

Outcome measures: (i) The clinical time required for bond up of upper and lower arches of both systems, (ii) bond failure rate for the first 6 months.

Design: Single centre randomized controlled clinical study. Thirty-three patients were bonded using a split mouth technique: randomly allocating the pre-coated brackets to upper left and lower right quadrants, and non-pre-coated brackets to the other quadrants.

Setting: Hospital Orthodontic Department, Basingstoke, Hampshire, UK.

Subjects: Orthodontic patients requiring fixed appliances.

Main outcome measures: The site and time to bond failure was recorded for each bracket that failed over the first 6 months. The time required to bond upper and lower arches was measured using a stopwatch for each patient.

Results: t-Test for the difference of mean time needed to apply both groups of brackets, no significant difference (P > 0.2) was found. A chi-squared test for the difference in bracket failure between pre-coated (8.06%) and non-pre-coated (7.37%) showed no significant difference in bracket failure (P > 0.2).

Conclusions: The clinical failure rate of pre-coated brackets is not significantly lower than conventional non-pre-coated brackets.

Keywords:

• Pre-coated brackets
• bondfailure
• bonding time

Acknowledgments

Many thanks to 3M Unitek who sponsored this project by providing the brackets, adhesives, and wires used in this study, and Mandy Mills the 3M Unitek representative for her assistance. We would like to thank Greg Ashton and Andrea Steptoe, who were the laboratory support, as well as the nurses in the orthodontic department who carried out additional clinical duties. Thanks also to Dr M. Garcia and K. Kelley for their statistical support.