Condition category
Oral Health
Date applied
29/09/2006
Date assigned
29/09/2006
Last edited
20/07/2016
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 Norvishie Arkutu

ORCID ID

Contact details

University Hospital of North Staffordshire
Orthodontic Department
Central Outpatients Department
Hartshill Road
Hartshill
Stoke-on-Trent
ST4 7PA
United Kingdom
+44 (0)1782 554 697
bdh1234@hotmail.com

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N0158163754

Study information

Scientific title

A randomised clinical trial to compare bond failure rates with and without the use of Ortho Solo

Acronym

Study hypothesis

1. To determine whether there is a difference in the number of orthodontic attachments that come off the teeth with and without the use of Ortho Solo.
2. In what time frame do bond failures occur?

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

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Oral Health: Orthodontics

Intervention

Patients are to be invited to participate if they are to have a fixed orthodontic appliance at the University Hospital of North Staffordshire Hospital NHS Trust, Orthodontic department. Consent is to be obtained by the clinician looking after the patient and with the use of a patient information sheet and consent form approved by the ethics committee. Each participant will have half the orthodontic appliance placed using the usual procedure and the other half placed with the addition of Orthosolo. This requires painting a layer of liquid onto the tooth. At each appointment the number and location of bond failures i.e. where the brace has come off the tooth, will be recorded and in this way it will be possible to compare bond failures with and without the use of Orthosolo. Where bond failure has occurred, the bracket will be replaced with the same method as previously used. At the end of the trial, the participant will continue with their routine orthodontic treatment.

Intervention type

Other

Phase

Not Applicable

Drug names

Primary outcome measures

1. Number of debonds to occur in a year with and without the use of Ortho Solo
2. The time from attaching the brace to debond with and without the use of Ortho Solo

Secondary outcome measures

Not provided at time of registration

Overall trial start date

01/01/2005

Overall trial end date

01/06/2006

Reason abandoned

Eligibility

Participant inclusion criteria

Any patient who is to have a fixed appliance placed at the North Staffordshire Hospital Orthodontic Department

Participant type

Patient

Age group

Not Specified

Gender

Not Specified

Target number of participants

Not provided at time of registration

Participant exclusion criteria

1. Enamel surfaces presenting with caries, fillings or gingival hyperplasia.
2. Molar brackets

Recruitment start date

01/01/2005

Recruitment end date

01/06/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

University Hospital of North Staffordshire
Stoke-on-Trent
ST4 7PA
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

Government

Funder name

North Staffordshire Research and Development Consortium (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

20/07/2016: No publications found, study status unverified