Condition category
Oral Health
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
29/01/2015
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Not provided at time of registration

Trial website

Contact information

Type

Scientific

Primary contact

Mr MJC Wake

ORCID ID

Contact details

Craniofacial
Queen Elizabeth Hospital
Birmingham
B15 2TH
United Kingdom

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

http://www.dh.gov.uk/Home/fs/en

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

Publication citations

Additional files

Editorial Notes