A prospective randomised clinical trial to compare pain levels of two orthodontic fixed bracket systems
| ISRCTN | ISRCTN05296896 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05296896 |
| Secondary identifying numbers | N/A |
- Submission date
- 13/03/2005
- Registration date
- 31/03/2005
- Last edited
- 29/01/2010
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Mary McKnight
Scientific
Scientific
Department of Oral and Maxillofacial Surgery and Orthodontics
The John Radcliffe
Headley Way
Headington
Oxford
OX3 9DU
United Kingdom
Study information
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Scientific title | |
| Study objectives | 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(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | 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 |
| Primary outcome measure | 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 study start date | 01/06/2005 |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 112 |
| Key inclusion criteria | Patients requiring orthodontic treatment with fixed appliances |
| Key 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 |
| Date of first enrolment | 01/06/2005 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Oral and Maxillofacial Surgery and Orthodontics
Oxford
OX3 9DU
United Kingdom
OX3 9DU
United Kingdom
Sponsor information
Oxford Radcliffe Hospitals NHS Trust (UK)
Hospital/treatment centre
Hospital/treatment centre
Department of Oral and Maxillofacial Surgery and Orthodontics
The John Radcliffe
Headley Way
Headington
Oxford
OX3 9DU
England
United Kingdom
"ROR" |
https://ror.org/03h2bh287 |
|---|
Funders
Funder type
Government
Oxford Radcliffe Hospitals NHS Trust (UK)
No information available
Results and Publications
| Intention to publish date | |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not provided at time of registration |
| Publication and dissemination plan | Not provided at time of registration |
| IPD sharing plan |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results | 01/08/2009 | Yes | No |
