Submission date
12/09/2003
Registration date
12/09/2003
Last edited
13/01/2010
Recruitment status
Stopped
Overall study status
Stopped
Condition category
Oral Health
Retrospectively registered
? Protocol not yet added
? SAP not yet added
Results not expected as study has stopped
Raw data not expected as study has stopped
Study stopped

Plain English Summary

Not provided at time of registration

Study website

Contact information

Type

Scientific

Contact name

Dr Philip Benson

ORCID ID

Contact details

University of Sheffield
Child Dental Health
Charles Clifford Dental Hospital
Sheffield
S10 2SZ
United Kingdom
+44 (0)114 271 7895 / 7885
p.benson@sheffield.ac.uk

Additional identifiers

EudraCT/CTIS number

IRAS number

ClinicalTrials.gov number

Protocol/serial number

N0059094047

Study information

Scientific title

Acronym

Study hypothesis

1. To record the success rate and time to emergence of the unerupted incisor following initial surgery between groups
2. To determine any differences in the re-operation rate between the two groups
3. To determine differences (if any) in the periodontal status of the (originally) unerupted incisor in the two groups
4. To determine the average number of treatment visits required for each group
5. To determine the relative acceptability (from patient and parent perspectives) of each treatment method

Ethics approval(s)

Not provided at time of registration

Study design

Randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Study setting(s)

Not specified

Study type

Not Specified

Patient information sheet

Condition

Oral Health: Orthodontics

Intervention

Not provided at time of registration
Notified 2005: trial stopped due to poor recruitment.

Intervention type

Other

Primary outcome measure

Tooth eruption.

Secondary outcome measures

Not provided at time of registration

Overall study start date

01/01/2001

Overall study end date

01/01/2005

Reason abandoned (if study stopped)

Participant recruitment issue

Eligibility

Participant inclusion criteria

Children.

Participant type(s)

Patient

Age group

Child

Sex

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/01/2001

Recruitment end date

01/01/2005

Locations

Countries of recruitment

England, United Kingdom

Study participating centre

University of Sheffield
Sheffield
S10 2SZ
United Kingdom

Sponsor information

Organisation

Department of Health (UK)

Sponsor details

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Sponsor type

Government

Website

http://www.doh.gov.uk

Funders

Funder type

Government

Funder name

Sheffield Teaching Hospitals (Central Campus) (UK)

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

Individual participant data (IPD) sharing plan

IPD sharing plan summary

Not provided at time of registration

Study outputs

Output type Details Date created Date added Peer reviewed? Patient-facing?

Additional files

Editorial Notes