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Bond Failure of Two Types of Molar Buccal Tubes

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03476161
Recruitment Status : Completed
First Posted : March 23, 2018
Last Update Posted : June 11, 2018
Sponsor:
Information provided by (Responsible Party):
Guy's and St Thomas' NHS Foundation Trust

Study Description
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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.


Condition or disease Intervention/treatment Phase
Orthodontic Appliance Complication Device: 3M Unitek Victory Series™ Superior Fit Buccal Tube with APC™ Flash-Free Adhesive. 4069-6103 / 4069-6114 / 4069-6203 / 4069-6214 Device: 3M Unitek Victory Series™ Superior Fit Buccal Tube with APC™ II Adhesive. 3069-6103 / 3069-6114 / 3069-6203 / 3069-6214 Not Applicable

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 56 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Other
Official Title: A Randomised Controlled Trial Comparing Bond Failure of Buccal Tubes Bonded With Conventional Pre-coated Adhesive vs Flash-free Buccal Tubes
Actual Study Start Date : May 8, 2017
Actual Primary Completion Date : June 1, 2018
Actual Study Completion Date : June 1, 2018
Arms and Interventions
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Arm Intervention/treatment
Group 1

upper 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

 Device: 3M Unitek Victory Series™ Superior Fit Buccal Tube with APC™ Flash-Free Adhesive. 4069-6103 / 4069-6114 / 4069-6203 / 4069-6214
One type of first permanent molar buccal tube used for fixed orthodontic treatment. One types of adhesive, with same buccal tube base.

Device: 3M Unitek Victory Series™ Superior Fit Buccal Tube with APC™ II Adhesive. 3069-6103 / 3069-6114 / 3069-6203 / 3069-6214
One type of first permanent molar buccal tube used for fixed orthodontic treatment. One types of adhesive, with same buccal tube base.
Group 2

upper 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

 Device: 3M Unitek Victory Series™ Superior Fit Buccal Tube with APC™ Flash-Free Adhesive. 4069-6103 / 4069-6114 / 4069-6203 / 4069-6214
One type of first permanent molar buccal tube used for fixed orthodontic treatment. One types of adhesive, with same buccal tube base.

Device: 3M Unitek Victory Series™ Superior Fit Buccal Tube with APC™ II Adhesive. 3069-6103 / 3069-6114 / 3069-6203 / 3069-6214
One type of first permanent molar buccal tube used for fixed orthodontic treatment. One types of adhesive, with same buccal tube base.


Outcome Measures
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Primary Outcome Measures :
  1. Difference in bond failure rate between the two molar buccal tubes. [ Time Frame: 3 months ]
    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.


Eligibility Criteria
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Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   8 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • Patients requiring fixed appliances.
  • Patients aged >8 years old

Exclusion Criteria:

  • 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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03476161


Locations
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United Kingdom
Guy's and St Thomas' NHS Foundation Trust
London, United Kingdom, SE1 9RT
Sponsors and Collaborators
Guy's and St Thomas' NHS Foundation Trust
More Information
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Responsible Party: Guy's and St Thomas' NHS Foundation Trust
ClinicalTrials.gov Identifier: NCT03476161    
Other Study ID Numbers: 213576
First Posted: March 23, 2018    Key Record Dates
Last Update Posted: June 11, 2018
Last Verified: June 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No