The effect of a fluoride releasing, non-primer step required, no mix composite: A clinical trial
| ISRCTN | ISRCTN05340070 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN05340070 |
| Secondary identifying numbers | N0263139746 |
- Submission date
- 30/09/2004
- Registration date
- 30/09/2004
- Last edited
- 28/02/2014
- 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 Samantha Hodge
Scientific
Scientific
Department of Orthodontics
Eastman Dental Hospital
256 Gray's Inn Road
London
WC1X 8LD
United Kingdom
| Phone | +44 (0)20 7915 1000 |
|---|
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 | To determine the failure rate and survival time of orthodontic bands cemented with a fluoride releasing, non-primer step required, no mix composite compared with a conventional no-mix composite and if there is a difference in demineralisation. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health: Orthodontics |
| Intervention | 1. Fluoride releasing, non-primer step required, no mix composite 2. Conventional no mix composite |
| Intervention type | Other |
| Primary outcome measure | The site and time to bond failure to be recorded for each bracket that fails over a six month period (in the first instance) and then up to the completion of treatment. |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 17/03/2004 |
| Completion date | 01/07/2007 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 50 patients from Orthodontics |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 17/03/2004 |
| Date of final enrolment | 01/07/2007 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Department of Orthodontics
London
WC1X 8LD
United Kingdom
WC1X 8LD
United Kingdom
Sponsor information
Department of Health
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.dh.gov.uk/Home/fs/en |
|---|
Funders
Funder type
Government
University College London 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 |
