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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT03476161
Other study ID # 213576
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date May 8, 2017
Est. completion date June 1, 2018

Study information

Verified date June 2018
Source Guy's and St Thomas' NHS Foundation Trust
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Completed
Enrollment 56
Est. completion date June 1, 2018
Est. primary completion date June 1, 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 8 Years and older
Eligibility 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.

Study Design


Related Conditions & MeSH terms

  • Orthodontic Appliance Complication

Intervention

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.
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.

Locations

Country Name City State
United Kingdom Guy's and St Thomas' NHS Foundation Trust London

Sponsors (1)

Lead Sponsor Collaborator
Guy's and St Thomas' NHS Foundation Trust

Country where clinical trial is conducted

United Kingdom, 

Outcome

Type Measure Description Time frame Safety issue
Primary 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
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