Condition category
Oral Health
Date applied
30/09/2005
Date assigned
30/09/2005
Last edited
12/04/2011
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

Dr Martyn Cobourne

ORCID ID

Contact details

Department of Orthodontics
F22 Guy's Tower
Guy's Hospital
St Thomas Street
London
SE1 9RT
United Kingdom
+44 (0)20 7188 4432
martyn.cobourne@kcl.ac.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0013154732

Study information

Scientific title

Acronym

Study hypothesis

Recently a ligature free orthodontic bracket system has been introduced. It has been suggested that reduced friction associated with this system can provide considerable benefits to the patient, principally because the teeth align more rapidly. We propose to investigate the alignment rate of two fixed orthodontic vracked systems; Ormco Damon-2 self -ligating and Ormco Synthesis conventional siamese.

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

Not Specified

Patient information sheet

Condition

Oral Health

Intervention

A Prospective Randomised Controlled Clinical Trial comparing Ormco Damon 2 ligature free bracket system and Ormco conventional pre-adjusted edgewise bracket system. The patients will be given a "pain diary " to complete and they will be reviewed six weekly. Patients will be randomly allocated to one of the two groups.

Intervention type

Other

Phase

Not Specified

Drug names

Primary outcome measures

1. Speed of alignment of the lower labial segment
2. Self reported pain or discomfort and root resorption of lower central incisors

Secondary outcome measures

Not provided at time of registration

Overall trial start date

08/11/2004

Overall trial end date

30/11/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Children under the age of 16, fit and well and not taking any medication; who present with a crowded dentition that require extraction of first pre-molars and fixed appliance therapy. 30 patients at Guy's and 30 at Canterbury.

Participant type

Patient

Age group

Child

Gender

Not Specified

Target number of participants

60

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

08/11/2004

Recruitment end date

30/11/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Department of Orthodontics
London
SE1 9RT
United Kingdom

Sponsor information

Organisation

Department of Health

Sponsor details

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

Government

Funder name

Guy's and St. Thomas' NHS Foundation Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

Own account

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

2008 results in http://www.ncbi.nlm.nih.gov/pubmed/18339656

Publication citations

  1. Results

    Scott P, Sherriff M, Dibiase AT, Cobourne MT, Perception of discomfort during initial orthodontic tooth alignment using a self-ligating or conventional bracket system: a randomized clinical trial., Eur J Orthod, 2008, 30, 3, 227-232, doi: 10.1093/ejo/cjm131.

Additional files

Editorial Notes