A randomised clinical trial to compare bond failure rates with and without the use of Ortho Solo
| ISRCTN | ISRCTN41545651 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN41545651 |
| Protocol serial number | N0158163754 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funder | North Staffordshire Research and Development Consortium (UK) |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 20/07/2016
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Prospectively registered
Protocol
Statistical analysis plan
Results
Individual participant data
Record updated in last year
Plain English summary of protocol
Not provided at time of registration
Contact information
Miss Norvishie Arkutu
Scientific
Scientific
University Hospital of North Staffordshire
Orthodontic Department
Central Outpatients Department
Hartshill Road, Hartshill
Stoke-on-Trent
ST4 7PA
United Kingdom
| Phone | +44 (0)1782 554 697 |
|---|---|
| bdh1234@hotmail.com |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised clinical trial to compare bond failure rates with and without the use of Ortho Solo |
| Study objectives | 1. To determine whether there is a difference in the number of orthodontic attachments that come off the teeth with and without the use of Ortho Solo. 2. In what time frame do bond failures occur? |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health: Orthodontics |
| Intervention | Patients are to be invited to participate if they are to have a fixed orthodontic appliance at the University Hospital of North Staffordshire Hospital NHS Trust, Orthodontic department. Consent is to be obtained by the clinician looking after the patient and with the use of a patient information sheet and consent form approved by the ethics committee. Each participant will have half the orthodontic appliance placed using the usual procedure and the other half placed with the addition of Orthosolo. This requires painting a layer of liquid onto the tooth. At each appointment the number and location of bond failures i.e. where the brace has come off the tooth, will be recorded and in this way it will be possible to compare bond failures with and without the use of Orthosolo. Where bond failure has occurred, the bracket will be replaced with the same method as previously used. At the end of the trial, the participant will continue with their routine orthodontic treatment. |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Number of debonds to occur in a year with and without the use of Ortho Solo |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Key inclusion criteria | Any patient who is to have a fixed appliance placed at the North Staffordshire Hospital Orthodontic Department |
| Key exclusion criteria | 1. Enamel surfaces presenting with caries, fillings or gingival hyperplasia. 2. Molar brackets |
| Date of first enrolment | 01/01/2005 |
| Date of final enrolment | 01/06/2006 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University Hospital of North Staffordshire
Stoke-on-Trent
ST4 7PA
United Kingdom
ST4 7PA
United Kingdom
Results and Publications
| Individual participant data (IPD) Intention to share | No |
|---|---|
| IPD sharing plan summary | Not provided at time of registration |
| IPD sharing plan |
Editorial Notes
20/07/2016: No publications found, study status unverified
