Additional identifiers
EudraCT number
ClinicalTrials.gov number
Protocol/serial number
N0265073460
Study information
Scientific title
Is preliminary orthodontic treatment of benefit to the success of alveolar bone grafting?
Acronym
Study hypothesis
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
Not provided at time of registration
Study design
Randomised controlled trial
Primary study design
Interventional
Secondary study design
Randomised controlled trial
Trial setting
Not specified
Trial type
Treatment
Patient information sheet
Not available in web format, please use the contact details below to request a patient information sheet
Condition
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
Phase
Drug names
Primary outcome measures
Not provided at time of registration
Secondary outcome measures
Not provided at time of registration
Overall trial start date
18/04/2000
Overall trial end date
18/04/2008
Reason abandoned
Eligibility
Participant inclusion criteria
Not provided at time of registration
Participant type
Patient
Age group
Not Specified
Gender
Not Specified
Target number of participants
100
Participant exclusion criteria
Not provided at time of registration
Recruitment start date
18/04/2000
Recruitment end date
18/04/2008
Locations
Countries of recruitment
United Kingdom
Trial participating centre
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom
Sponsor information
Organisation
Record Provided by the NHSTCT Register - 2006 Update - Department of Health
Sponsor details
The Department of Health
Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom
+44 (0)20 7307 2622
dhmail@doh.gsi.org.uk
Sponsor type
Government
Website
Funders
Funder type
Hospital/treatment centre
Funder name
University Hospital Birmingham NHS Trust (UK)
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Funder name
NHS R&D Support Funding
Alternative name(s)
Funding Body Type
Funding Body Subtype
Location
Results and Publications
Publication and dissemination plan
Not provided at time of registration
Intention to publish date
Participant level data
Not provided at time of registration
Results - basic reporting
Publication summary