Orthodontic Appliance Complication Clinical Trial
Official title:
A Randomised Controlled Trial Comparing Bond Failure of Buccal Tubes Bonded With Conventional Pre-coated Adhesive vs Flash-free Buccal Tubes
This study looks at two new types of orthodontic brackets (metal squares of the brace) that
have recently been released. Both types have been developed to allow the brackets to stick
better to the tooth surface. The difference between the two groups is the adhesive ('glue')
that is used. One uses a more conventional type of pre-coated adhesive (APC-II). The other
type uses a new flash-free adhesive that does not require the excess to be removed once
placed. It is claimed by the manufacturer that this new adhesive has a far lower failure rate
than other types. However, there are very few studies that have looked into the bond failures
of these adhesives comparatively, with most being lab-based studies outside of the mouth.
The purpose of this study is to investigate which of the two bracket types lasts longest when
glued to teeth for brace treatment and if there are any particular reasons why they may fail.
This in turn will provide good evidence and research for future use of different bracket
types, with an aim to prevent brackets from coming loose as little as possible during
treatment. This could potentially result in smoother treatment for the participants and fewer
visits.
A total of 56 participants within the Orthodontic Department at Guy's Hospital London, shall
be recruited to the trial and randomly placed into one of the two groups. The participants
invited to take part in the trial will require fixed braces ('train-tracks') and meet the
specific criteria that the investigators are looking for. Once the braces are fitted, regular
appointments are made and participants are asked to return for emergency appointments if any
of the brace comes loose. The total time for follow-up after the brace is fitted is a maximum
of 3 months. The results shall then be analysed.
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