Condition category
Oral Health
Date applied
13/03/2005
Date assigned
31/03/2005
Last edited
29/01/2010
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Miss Mary McKnight

ORCID ID

Contact details

Department of Oral and Maxillofacial Surgery and Orthodontics
The John Radcliffe
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Acronym

Study hypothesis

Pain is frequently experienced by patients, particularly during the early stages of orthodontic treatment, when the teeth are being moved. The pain is thought to be due to forces applied to the teeth during tooth movement with orthodontic fixed appliances or "braces". Pain experienced is unpredictable and usually peaks at 48 to 72 hours after the brace has been adjusted. Not all patients complete their orthodontic treatment because of the pain experienced at the start of treatment. An alternative type of fixed orthodontic bracket has been designed which the manufacturers claim is less painful to the patient during treatment. However, there is no independent evidence to support this finding. The
bracket passively holds the orthodontic wire in position and is said to reduce friction. The standard orthodontic bracket holds the wire in position using small elastic bands which impart more friction, therefore more force is needed to overcome the friction and move the tooth.
The aim of this study is to establish whether the new type of orthodontic bracket results in less pain for the patient. Secondarily it will establish whether the treatment duration is reduced, whether space closure between teeth is faster and whether the time taken to adjust the brace is reduced.
Null Hypothesis: there is no difference in pain experienced by patients when comparing the true straight orthodontic bracket and the Damon bracket
Study Hypothesis: patients experience less pain during fixed orthodontic treatment using the Damon bracket as compared with the true straight bracket.

Ethics approval

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Not specified

Trial type

Treatment

Patient information sheet

Condition

Pain levels during orthodontic treatment

Intervention

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.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

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

Secondary outcome measures

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?

Overall trial start date

01/06/2005

Overall trial end date

30/06/2008

Reason abandoned

Eligibility

Participant inclusion criteria

Patients requiring orthodontic treatment with fixed appliances

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

112

Participant 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

Recruitment start date

01/06/2005

Recruitment end date

30/06/2008

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Oral and Maxillofacial Surgery and Orthodontics
Oxford
OX3 9DU
United Kingdom

Sponsor information

Organisation

Oxford Radcliffe Hospitals NHS Trust (UK)

Sponsor details

Department of Oral and Maxillofacial Surgery and Orthodontics
The John Radcliffe
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom

Sponsor type

Government

Website

Funders

Funder type

Government

Funder name

Oxford Radcliffe Hospitals NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Not provided at time of registration

Intention to publish date

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

2009 results in http://www.ncbi.nlm.nih.gov/pubmed/19651344

Publication citations

  1. Results

    Pringle AM, Petrie A, Cunningham SJ, McKnight M, Prospective randomized clinical trial to compare pain levels associated with 2 orthodontic fixed bracket systems., Am J Orthod Dentofacial Orthop, 2009, 136, 2, 160-167, doi: 10.1016/j.ajodo.2007.08.032.

Additional files

Editorial Notes