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 |
| Secondary identifying numbers | N0158163754 |
- 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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Hospital |
| Study type | Treatment |
| 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 | 1. Number of debonds to occur in a year with and without the use of Ortho Solo 2. The time from attaching the brace to debond with and without the use of Ortho Solo |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 01/01/2005 |
| Completion date | 01/06/2006 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | Not provided at time of registration |
| 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
- England
- United Kingdom
Study participating centre
University Hospital of North Staffordshire
Stoke-on-Trent
ST4 7PA
United Kingdom
ST4 7PA
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health, Richmond House, 79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Government
North Staffordshire Research and Development Consortium (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 |
Editorial Notes
20/07/2016: No publications found, study status unverified
