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A prospective randomised clinical trial to compare pain levels of two orthodontic fixed bracket systems

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ISRCTN
Registry ID
ISRCTN05296896
Enrollment
112
Registered
2005-03-31
Start date
2005-06-01
Completion date
Unknown
Last updated
2015-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Pain levels during orthodontic treatment Oral Health Orthodontics

Interventions

Randomisation of treatment to two fixed appliance systems - true straight bracket and the Damon bracket. Comparing pain levels, rate of space closure when teeth have been extracted, treatment duration

Sponsors

Oxford Radcliffe Hospitals NHS Trust (UK)
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: Patients requiring orthodontic treatment with fixed appliances

Exclusion criteria

Exclusion criteria: 1. Those patients under the age of 16 will only be asked if they are accompanied by a parent or legal guardian 2. Patient undergoing active headgear treatment 3. Patients undergoing maxillary expansion with either quadhelix, rapid maxillary expansion device or a upper removable appliance with midline expansion screw 4. Patients unable to speak English will unfortunately have to be excluded from the study as it will be difficult to ensure that exactly the same information is provided in all languages even with the benefit of professional interpreting staff

Design outcomes

Primary

MeasureTime frame
Does an alternative design of orthodontic fixed brace result in less pain for the patients during orthodontic treatment?

Secondary

MeasureTime frame
Does the alternative orthodontic brace reduce treatment duration? Does the alternative orthodontic brace allow space between teeth to be closed faster than the conventional orthodontic brace when teeth have been extracted? Is the alternative orthodontic brace quicker and easier to adjust during treatment?

Countries

United Kingdom

Outcome results

None listed

Source: ISRCTN (via WHO ICTRP) · Data processed: Feb 4, 2026