Is preliminary orthodontic treatment of benefit to the success of alveolar bone grafting?
| ISRCTN | ISRCTN53821842 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN53821842 |
| Protocol serial number | N0265073460 |
| Sponsor | Record Provided by the NHSTCT Register - 2006 Update - Department of Health |
| Funders | University Hospital Birmingham NHS Trust (UK), NHS R&D Support Funding |
- 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
| Primary study design | Interventional |
|---|---|
| Study design | Randomised controlled trial |
| Secondary study design | Randomised controlled trial |
| Study type | Participant 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(s) |
Not provided at time of registration |
| Key secondary outcome measure(s) |
Not provided at time of registration |
| Completion date | 18/04/2008 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Not Specified |
| Sex | Not Specified |
| Target sample size at registration | 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
- United Kingdom
- England
Study participating centre
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
B15 2TH
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? |
|---|---|---|---|---|---|
| Participant information sheet | Participant information sheet | 11/11/2025 | 11/11/2025 | No | Yes |
