Is preliminary orthodontic treatment of benefit to the success of alveolar bone grafting?
| ISRCTN | ISRCTN53821842 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53821842 |
| Secondary identifying numbers | N0265073460 |
- Submission date
- 29/09/2006
- Registration date
- 29/09/2006
- Last edited
- 29/01/2015
- 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
Mr MJC Wake
Scientific
Scientific
Craniofacial
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
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 | Is preliminary orthodontic treatment of benefit to the success of alveolar bone grafting? |
| Study objectives | A randomly controlled trial be established to test the following null hypothesis, that there is no difference in the outcome of the bone grafting procedure for patients who have had orthodontic upper arch dental expansion treatment, prior to bone grafting, versus those who have not. In addition it is proposed to estimate the cost of treatment in terms of number of appointments. |
| Ethics approval(s) | Not provided at time of registration |
| Health condition(s) or problem(s) studied | Oral health |
| Intervention | Patients will be divided into two groups. 50 patients for each group. A control group will exist which will have bone grafting but with no preliminary orthodontic treatment, and a treatment group that has bone grafting preceded by orthodontic treatment to expand the upper dental arch. It is estimated that it will take 24 months to recruit this number of patients and a further year to collect the results. The investigations used are those usually obtained to assess growth and dental development in this group of patients. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | Not provided at time of registration |
| Secondary outcome measures | Not provided at time of registration |
| Overall study start date | 18/04/2000 |
| Completion date | 18/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target number of participants | 100 |
| Key inclusion criteria | Not provided at time of registration |
| Key exclusion criteria | Not provided at time of registration |
| Date of first enrolment | 18/04/2000 |
| Date of final enrolment | 18/04/2008 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
B15 2TH
United Kingdom
Sponsor information
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Government
Government
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
| Phone | +44 (0)20 7307 2622 |
|---|---|
| dhmail@doh.gsi.org.uk | |
| Website | http://www.dh.gov.uk/Home/fs/en |
Funders
Funder type
Hospital/treatment centre
University Hospital Birmingham NHS Trust (UK)
No information available
NHS R&D Support Funding
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 |
