A randomised controlled trial investigating the orthodontic bracket bond failure rates using Ortho Solo Universal bond enhancer compared to a conventional bonding primer
| ISRCTN | ISRCTN35457694 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN35457694 |
| Protocol serial number | N0264149441 |
| Sponsor | Department of Health |
| Funders | United Bristol Healthcare NHS Trust (UK), NHS R&D Support Funding (UK) |
- Submission date
- 30/09/2005
- Registration date
- 30/09/2005
- Last edited
- 04/08/2008
- 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
Mr N W T Harradine
Scientific
Scientific
C/O Research & Effectiveness Department
Level 1, The Old Building
Bristol Royal Infirmary
Malborough Street
Bristol
BS2 8HW
United Kingdom
| Phone | +44 (0)117 928 3473 |
|---|---|
| r&eoffice@ubht.swest.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To investigate if a new glue system reduces the number of brackets (orthodontic brace attachments to teeth) which debond (glue fails) during treatment with fixed braces. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health |
| Intervention | A split mouth design will be used with right and left in the upper arch decided by random allocation with random number tables. Only incisors, canines and premolars will be included in the study. The two types of primer to be used for bonding are the following: 1. OrthoSolo Bond enhancer 2. Transbond XT conventional adhesive |
| Intervention type | Other |
| Primary outcome measure(s) |
Bond failure rate. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 30/06/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Upper age limit | 16 Years |
| Sex | Not Specified |
| Target sample size at registration | 33 |
| Key inclusion criteria | 1. Aged 16 or under 2. Both arches to be treated with fixed appliances 3. Written consent given to be included in the trial |
| Key exclusion criteria | Patients not meeting inclusion criteria. |
| Date of first enrolment | 01/07/2004 |
| Date of final enrolment | 30/06/2008 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
C/O Research & Effectiveness Department
Bristol
BS2 8HW
United Kingdom
BS2 8HW
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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | Results | 01/03/2008 | Yes | No |
