Palatal implants versus headgear for orthodontic anchorage - a randomised controlled trial
| ISRCTN | ISRCTN24433142 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN24433142 |
| Secondary identifying numbers | N0059108300 |
- Submission date
- 12/09/2003
- Registration date
- 12/09/2003
- Last edited
- 02/07/2008
- 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
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
| Study design | Randomised controlled trial |
|---|---|
| Primary study design | Interventional |
| Secondary study design | Randomised controlled trial |
| Study setting(s) | Not specified |
| Study type | Treatment |
| Participant information sheet | Not available in web format, please use the contact details below to request a patient information sheet. |
| Scientific title | |
| Study objectives | To evaluate the clinical effectiveness of the mid-sagittal implant as a method of preventing unwanted tooth movement (anchorage) during orthodontic treatment. The anchorage offered by implants will be compared with that from conventional orthodontic anchorage reinforcement techniques. |
| Ethics approval(s) | Added July 2008: Ethical approval for this study was obtained from North Derbyshire Health and South Sheffield Local Research Ethics committees. |
| Health condition(s) or problem(s) studied | Oral Health: Orthodontics |
| Intervention | The anchorage offered by implants will be compared with that from conventional orthodontic anchorage reinforcement techniques. |
| Intervention type | Other |
| Primary outcome measure | Tooth movement. The difference in the mesial drift of the buccal teeth to be calculated: a. Relative to the cranial base using the Pitchfork analysis (Luecke and Johnston, 1992; Johnston, 1996) on the start and finish lateral cephalometric radiograph b. Relative to the palatal rugae, from the start and finish study models (Hoggan and Sadowsky, 2001) |
| Secondary outcome measures | 1. Implant stability, discomfort and any signs of inflammation of the peri-implant tissues will be recorded with percussion tests using a Resonance Frequency Analyser (Meredith, 1998) and standard periodontal indices 2. Patient acceptability, compliance and discomfort measured using a questionnaire 3. Treatment outcome measured with the Peer Assessment Rating (PAR) index on the pre- and post-treatment study models |
| Overall study start date | 01/01/2002 |
| Completion date | 01/06/2005 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Adult |
| Sex | Both |
| Target number of participants | 40 patients |
| Key inclusion criteria | Added July 2008: The patients in the study all needed absolute anchorage, and no forward movement of upper molars could be allowed for successful treatment. |
| Key exclusion criteria | Added July 2008: Poor oral hygiene, unwilling to wear fixed appliances, unwilling to wear headgear or have the implant placed, and medical history precluding fixed appliance treatment. |
| Date of first enrolment | 01/01/2002 |
| Date of final enrolment | 01/06/2005 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
University of Sheffield
Sheffield
S10 2SZ
United Kingdom
S10 2SZ
United Kingdom
Sponsor information
Department of Health (UK)
Government
Government
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Website | http://www.doh.gov.uk |
|---|
Funders
Funder type
Government
Sheffield Teaching Hospitals (Central Campus) - 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 |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| Results article | results on main outcome | 01/11/2007 | Yes | No | |
| Results article | results on other outcomes | 01/01/2008 | Yes | No |
