A randomised prospective clinical trial to compare two different methods of applying a new resin-reinforced chemically-cured "moisture-friendly" glass ionomer cement for the bonding of orthodontic brackets
| ISRCTN | ISRCTN61972161 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN61972161 |
| Protocol serial number | N0436121385 |
| Sponsor | Department of Health (UK) |
| Funder | Leeds Teaching Hospitals NHS Trust (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 17/12/2019
- 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 DO Morris
Scientific
Scientific
Oral and Maxillo-facial Surgery
Chancellor Wing
St James's University Hospital
Beckett Street
Leeds
LS9 7TF
United Kingdom
| Phone | +44 (0)113 206 3697 |
|---|---|
| david.morris@leedsth.nhs.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | A randomised prospective clinical trial to compare two different methods of applying a new resin-reinforced chemically-cured "moisture-friendly" glass ionomer cement for the bonding of orthodontic brackets |
| Study objectives | The study will be used to investigate the clinical failure rate, using the survival rate analysis, of orthodontic brackets bonded using a new resin-reinforced, chemically cured "moisture-friendly" glass ionomer cement by two recommended methods. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Dental Materials |
| Intervention | Randomised controlled trial. Random allocation to: A. Method 1 B. Method 2 |
| Intervention type | Other |
| Primary outcome measure(s) |
1. Bracket survival |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/10/2003 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 10 Years |
| Upper age limit | 18 Years |
| Sex | All |
| Target sample size at registration | 60 |
| Total final enrolment | 49 |
| Key inclusion criteria | 60 Consecutive healthy subjects aged between 10-18 years from the orthodontic treatment waiting list at St James's Hospital requiring orthodontic treatment with upper and lower fixed appliances will be randomly allocated to the two study groups. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/10/2001 |
| Date of final enrolment | 01/10/2003 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Oral and Maxillo-facial Surgery
Leeds
LS9 7TF
United Kingdom
LS9 7TF
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? |
|---|---|---|---|---|---|
| Abstract results | A clinical trial of Fuji ORTHO glass ionomer for orthodontic bonding | 01/06/2005 | 17/12/2019 | No | No |
| Abstract results | abstract page 140-141 | 01/06/2005 | 17/12/2019 | No | No |
Editorial Notes
17/12/2019: The following changes have been made:
1. Publication reference added.
2. The final enrolment number has been added.
05/12/2019: No publications found, verifying study status with principal investigator.
16/03/2016: No publications found, verifying study status with principal investigator.
