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A Randomized Controlled Trial to Investigate Brackets Bonded with a Hydrophilic Primer

¹ Department of Orthodontics, St Luke's Hospital, Little Horton Lane, Bradford, UK
² Sub-unit for Medical Statistics, Epidemiology & Health Services Research, 71–75 Clarendon Road, University of Leeds, Leeds, UK

Abstract

Objective: To compare the clinical failure rates of brackets bonded using a prototype hydrophilic primer, designed to be insensitive to moisture, with brackets bonded with a conventional primer.

Design: Single centre randomised controlled clinical study. Thirty-three patients were bonded using a split mouth technique: randomly allocating the hydrophilic primer to one side of the mouth and a conventional primer to the other.

Setting: Hospital orthodontic department, Bradford, 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 6 months.

Results: Using survival analysis, there was an increased risk of bracket failure when bonded with the hydrophilic primer compared with the conventional primer (hazard ratio = 2•2, 95% confidence interval: 1•1 to 4•5, P = 0•01).

Conclusions: This hydrophilic primer cannot be recommended for routine clinical use.

Key words: Hydrophilic Primer, Moisture Insensitive Primer, Orthodontic Bonding, Randomised Controlled Trial

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