Randomised controlled trial to evaluate two alternative strategies for the management of unerupted incisors obstructed by supernumerary teeth

ISRCTN ISRCTN86722161
DOI https://doi.org/10.1186/ISRCTN86722161
Secondary identifying numbers N0059094047
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
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

Dr Philip Benson
Scientific

University of Sheffield
Child Dental Health
Charles Clifford Dental Hospital
Sheffield
S10 2SZ
United Kingdom

Phone +44 (0)114 271 7895 / 7885
Email p.benson@sheffield.ac.uk

Study information

Study designRandomised controlled trial
Primary study designInterventional
Secondary study designRandomised controlled trial
Study setting(s)Not specified
Study typeNot Specified
Scientific title
Study objectives1. 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
Health condition(s) or problem(s) studiedOral Health: Orthodontics
InterventionNot provided at time of registration
Notified 2005: trial stopped due to poor recruitment.
Intervention typeOther
Primary outcome measureTooth eruption.
Secondary outcome measuresNot provided at time of registration
Overall study start date01/01/2001
Completion date01/01/2005
Reason abandoned (if study stopped)Participant recruitment issue

Eligibility

Participant type(s)Patient
Age groupChild
SexNot Specified
Target number of participantsNot provided at time of registration
Key inclusion criteriaChildren.
Key exclusion criteriaNot provided at time of registration
Date of first enrolment01/01/2001
Date of final enrolment01/01/2005

Locations

Countries of recruitment

  • England
  • United Kingdom

Study participating centre

University of Sheffield
Sheffield
S10 2SZ
United Kingdom

Sponsor information

Department of Health (UK)
Government

Richmond House
79 Whitehall
London
SW1A 2NL
United Kingdom

Website http://www.doh.gov.uk

Funders

Funder type

Government

Sheffield Teaching Hospitals (Central Campus) (UK)

No information available

Results and Publications

Intention to publish date
Individual participant data (IPD) Intention to shareNo
IPD sharing plan summaryNot provided at time of registration
Publication and dissemination planNot provided at time of registration
IPD sharing plan