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A randomized controlled trial to investigate brackets bonded with a hydrophilic primer
S J Littlewood1, L Mitchell, D C Greenwood
1Department of Orthodontics, St Luke's Hospital, Little Horton Lane, Bradford, UK.
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.