An RCT comparing bond failure of two types of molar buccal tubes
Research type
Research Study
Full title
A randomised controlled trial comparing bond failure of buccal tubes bonded with conventional pre-coated adhesive vs flash-free buccal tubes.
IRAS ID
213576
Contact name
Megan Faulkner
Contact email
Sponsor organisation
King’s College London
Clinicaltrials.gov Identifier
Duration of Study in the UK
1 years, 1 months, 12 days
Research summary
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. \n 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 patient and fewer visits. \nA total of 56 patients 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 patients invited to take part in the trial will require fixed braces (’train-tracks’) and meet the specific criteria that we are looking for. Once the braces are fitted, regular appointments are made and patients 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. \n\n\n
REC name
East of England - Cambridge Central Research Ethics Committee
REC reference
17/EE/0169
Date of REC Opinion
27 Apr 2017
REC opinion
Favourable Opinion