Bond Failure of Two Types of Molar Buccal Tubes
A Randomised Controlled Trial Comparing Bond Failure of Buccal Tubes Bonded With Conventional Pre-coated Adhesive vs Flash-free Buccal Tubes
1 other identifier
interventional
56
1 country
1
Brief 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. 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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started May 2017
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 8, 2017
CompletedFirst Submitted
Initial submission to the registry
March 16, 2018
CompletedFirst Posted
Study publicly available on registry
March 23, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
June 1, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2018
CompletedJune 11, 2018
June 1, 2018
1.1 years
March 16, 2018
June 8, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
Difference in bond failure rate between the two molar buccal tubes.
The primary outcome for this study was to detect failure rates associated with a 3M Unitek APC Flash-free adhesive compared to 3M Unitek APCII adhesive system when bonding first permanent molars with 3M Unitek Victory superior fit buccal tubes.
3 months
Study Arms (2)
Group 1
OTHERupper left and lower right 3M Unitek Victory Series™ Superior Fit Buccal Tube with APC™ Flash-Free Adhesive upper right and lower left 3M Unitek Victory Series™ Superior Fit Buccal Tube with APC™ II Adhesive
Group 2
OTHERupper right and lower left 3M Unitek Victory Series™ Superior Fit Buccal Tube with APC™ Flash-Free Adhesive upper left and lower right 3M Unitek Victory Series™ Superior Fit Buccal Tube with APC™ II Adhesive
Interventions
One type of first permanent molar buccal tube used for fixed orthodontic treatment. One types of adhesive, with same buccal tube base.
One type of first permanent molar buccal tube used for fixed orthodontic treatment. One types of adhesive, with same buccal tube base.
Eligibility Criteria
You may qualify if:
- Patients requiring fixed appliances.
- Patients aged \>8 years old
You may not qualify if:
- Orthognathic patients requiring bands on first permanent molar teeth.
- Patients with cleft lip/palate or any other craniofacial anomalies.
- Patients already in fixed appliances.
- Patients who have first permanent molars missing.
- Patients with hypoplastic first permanent molars/fluorotic first permanent molars.
- Patients with first permanent molars in crossbite with displacement.
- Patients requiring sectional fixed appliances (not including the molars).
- Patients requiring bands on first permanent molars for TPA, Quadhelix etc.
- Patients who have buccal restorations/crowned first permanent molars.
- Patients who do not speak English fluently or understand written English easily.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Guy's and St Thomas' NHS Foundation Trust
London, SE1 9RT, United Kingdom
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- OTHER
- Intervention Model
- CROSSOVER
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 16, 2018
First Posted
March 23, 2018
Study Start
May 8, 2017
Primary Completion
June 1, 2018
Study Completion
June 1, 2018
Last Updated
June 11, 2018
Record last verified: 2018-06
Data Sharing
- IPD Sharing
- Will not share