Randomised controlled trial to evaluate two alternative strategies for the management of unerupted incisors obstructed by supernumerary teeth
| ISRCTN | ISRCTN86722161 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN86722161 |
| Protocol serial number | N0059094047 |
| Sponsor | Department of Health (UK) |
| Funder | Sheffield Teaching Hospitals (Central Campus) (UK) |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 13/01/2010
- Recruitment status
- Stopped
- Overall study status
- Stopped
- 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
Dr Philip Benson
Scientific
Scientific
University of Sheffield
Child Dental Health
Charles Clifford Dental Hospital
Sheffield
S10 2SZ
United Kingdom
| Phone | +44 (0)114 271 7895 / 7885 |
|---|---|
| p.benson@sheffield.ac.uk |
Study information
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Scientific title | |
| Study objectives | 1. To record the success rate and time to emergence of the unerupted incisor following initial surgery between groups 2. To determine any differences in the re-operation rate between the two groups 3. To determine differences (if any) in the periodontal status of the (originally) unerupted incisor in the two groups 4. To determine the average number of treatment visits required for each group 5. To determine the relative acceptability (from patient and parent perspectives) of each treatment method |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral Health: Orthodontics |
| Intervention | Not provided at time of registration Notified 2005: trial stopped due to poor recruitment. |
| Intervention type | Other |
| Primary outcome measure(s) |
Tooth eruption. |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 01/01/2005 |
| Reason abandoned (if study stopped) | Participant recruitment issue |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Sex | Not Specified |
| Key inclusion criteria | Children. |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 01/01/2001 |
| Date of final enrolment | 01/01/2005 |
Locations
Countries of recruitment
- United Kingdom
- England
Study participating centre
University of Sheffield
Sheffield
S10 2SZ
United Kingdom
S10 2SZ
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 |
