Condition category
Oral Health
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
07/10/2014
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

Miss Tasnim Hassan

ORCID ID

Contact details

Orthodontic Department
Blackshaw Road
Tooting
London
SW17 0QT
United Kingdom
+44 (0)20 8672 1255/1257
tasnim1000@yahoo.co.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0236169540

Study information

Scientific title

Acronym

Study hypothesis

The aim of this research is to investigate and compare two methods of orthodontic bracket ligation (typing of the arch wire to the orthodontic brackets) and their effects on patient oral hygiene and microbial colonization. The two fixed appliances under investigation will be 3M conventional MBT Siamese brackets and £M self-ligating 'Smart Click' brackets.

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

Other

Trial type

Treatment

Patient information sheet

Condition

Oral Health

Intervention

Following consent, patients undergoing routine orthodontic treatment will be randomly allocated to one of two groups:
1. Treatment with conventional pre-adjusted edgewise brackets secured by elastic ties (victory series)
2. Treatment with ‘smart click’ pre-adjusted self-ligating brackets which do not require tying

Both systems would be of the same prescription and the same archwires would be used. All patients will receive instruction in oral hygiene from a hygienist within the department before the start of treatment. Following extraction of the teeth, upper and lower fixed appliances will be placed with an initial aligning archwire of 014 Nickel Titanium. Patients will be reviewed every 4 weeks for treatment.

The oral hygiene will be assessed and plaque and saliva samples will be taken (using non-invasive methods) before placement of the appliance, and then 3, 6 and 12 months following the placement of the appliances. At 6 months the rate of oral clearance of food will also be measured. All methods of assessment are non-invasive.

The oral hygiene will be assessed by:
1. Measuring the amount of dental plaque present on the outside surface of each tooth
2. Assessing the presence or absence of gingival (gum) swelling/inflammation and bleeding

The oral clearance of food will be measured once by asking the patient to eat a digestive biscuit for 1 minute, following which time the patient will be asked to produce a sample of saliva by spitting into a container. This will be collected by a qualified dentist.

All samples will then be analysed in the microbiology department at Guy's Hospital.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Patient oral hygiene as measured by plaque, and gingival indices
2. Microbiological profile of plaque bacteria
3. Salivary sugar levels to reflect the oral clearance of foods

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/08/2005

Overall trial end date

31/01/2007

Reason abandoned

Eligibility

Participant inclusion criteria

Patients recruited from the treatment waiting lists who present with a crowded dentition that requires the extraction of premolar teeth and fixed appliance therapy

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

Not provided at time of registration

Recruitment start date

01/08/2005

Recruitment end date

31/01/2007

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Orthodontic Department
London
SW17 0QT
United Kingdom

Sponsor information

Organisation

Record Provided by the NHSTCT Register - 2006 Update - Department of Health (UK)

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

Government

Funder name

St George's Healthcare NHS Trust (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

NHS R&D Support Funding (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

Participant level data

Not provided at time of registration

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes