A clinical and laboratory study of the performance of a dual-cured glass-ionomer cement as a bonding agent for orthodontic brackets.
| ISRCTN | ISRCTN70334837 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN70334837 |
| Protocol serial number | 94060005 |
| Sponsor | NHS R&D Regional Programme Register - Department of Health (UK) |
| Funder | NHS Executive Northern and Yorkshire (UK) |
- Submission date
- 23/01/2004
- Registration date
- 23/01/2004
- Last edited
- 18/01/2010
- 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 Nigel Carter
Scientific
Scientific
Dental School
Framlington Place
University of Newcastle
Newcastle upon Tyne
NE2 4BW
United Kingdom
| Phone | +44 (0)191 222 8347 |
|---|
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | To assess the clinical performance of a resin-modified glass ionomer cement as an orthodontic bonding agent, and to compare these findings with the results of laboratory tests of bond performance. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral health/stomatognathic diseases |
| Intervention | Each patient will be allocated randomly to one of three test groups : 1. Glass-ionomer without sandblasting vs. composite resin 2. Glass-ionomer with sandblasting vs. composite resin 3. Glass-ionomer with sandblasting vs. glass-ionomer without sandblasting |
| Intervention type | Other |
| Primary outcome measure(s) |
Clinical bracket failure rates. In vitro: bracket bond strengths and fatigue (assessed using a ball mill); fluoride release over time |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 04/01/1996 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Other |
| Sex | All |
| Key inclusion criteria | Patients attending for routine orthodontic treatment using fixed appliances. |
| Key exclusion criteria | Does not match inclusion criteria |
| Date of first enrolment | 04/01/1994 |
| Date of final enrolment | 04/01/1996 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
Dental School
Newcastle upon Tyne
NE2 4BW
United Kingdom
NE2 4BW
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 | 01/05/1995 | Yes | No |
