Condition category
Oral Health
Date applied
22/04/2016
Date assigned
12/05/2016
Last edited
30/08/2016
Prospective/Retrospective
Retrospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims
Class III malocclusion is where the lower jaw is larger and lies ahead of the top jaw, resulting in a reverse bite. Around 3-8% of European children have this sort of bite. It may result in difficulty biting food and children are often teased about their facial appearance. The management of severe class III cases often involves surgery. Around 2,500 teenagers have jaw surgery per year, of which 60% will be for class III problems. This costs around £13.5 million. Additionally, there are the risks of general anaesthesia and surgery, and injury to the nerve supplying feeling/sensation to the lower lip and chin. There is a treatment involving a facemask brace which is used to pull the top jaw and teeth forwards with elastics. This only works in children under 10 years old. They wear the facemask brace at night for about 8 months. As clinicians we need to decide whether to treat children at a young age with the facemask brace or simply to observe their jaw growth and treat them with facial surgery when they are 16 years old. There is not enough evidence about the long-term effects of the facemask brace and whether it would reduce the need for jaw surgery in the teenage years. Therefore the main focus of our study is to see whether early brace treatment means that a child does not need jaw surgery later.

Who can participate?
Patients aged 7-9 with class III malocclusion

What does the study involve?
Participants are randomly allocated to receive either facemask brace treatment or no treatment. All participants are followed up for 6 years to assess whether their reverse bite is corrected or whether they need jaw surgery.

What are the possible benefits and risks of participating?
Correction of the reverse bite at an early age might reduce the amount of orthodontic treatment or jaw surgery treatment that may be required later. There are no addition risks of participating – there is the routine risk of decalcification of the enamel around the brace if the teeth are not kept clean or if the patient has a high sugar diet.

Where is the study run from?
Tameside Hospital NHS Foundation Trust (lead site) (UK)

When is the study starting and how long is it expected to run for?
January 2004 to April 2014

Who is funding the study?
1. British Orthodontic Society (UK)
2. TP Orthodontics Europe

Who is the main contact?
Dr Nicky Mandall
Nicky.mandall@tgh.nhs.uk

Trial website

Contact information

Type

Scientific

Primary contact

Dr Nicky Mandall

ORCID ID

Contact details

Tameside Hospital NHS Foundation Trust
Fountain Street
Ashton under Lyne
OL6 9RW
United Kingdom
+44 (0)161 922 6461
Nicky.mandall@tgh.nhs.uk

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Early class III protraction facemask treatment reduces the need for orthognathic surgery: a multicentre, two-arm, parallel randomised controlled trial

Acronym

Early class III trial

Study hypothesis

The null hypotheses stated that early class III protraction facemask did not reduce the need for orthognathic surgery and that there were no differences between treated patients (Protraction Facemask Group, PFG) and the untreated/control group (CG) in terms of skeletal and occlusal changes, self-esteem and oral aesthetic impact of malocclusion.

Ethics approval

North West MREC, 18/02/2003, MREC 03/8/2

Study design

Interventional multi-centre randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised controlled trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Not available in web format, please use the contact details below to request a patient information sheet

Condition

Class III reverse bite with a class III skeletal face profile (small upper jaw and large lower jaw)

Intervention

Random allocation to protraction facemask treatment or no treatment/control groups.

The intervention was a protraction facemask treatment which is a head brace attached to an upper plastic brace. The upper plastic brace is cemented to the upper teeth. Elastics are attached from the plastic brace in the mouth to the head brace. The elastics and head brace are worn at night for about 8 months and this gradually corrects the reverse bite.

Intervention type

Device

Phase

Drug names

Primary outcome measures

1. Need for orthognathic surgery: measured at 6 year follow-up using expert panel consensus
2. Skeletal change: measured from lateral cephalogram facial radiographs at 15 months, 3 years and 6 years follow-up
3. Dental change, correction of reverse bite: measured from dental models at 15 months, 3 years and 6 years follow-up

Secondary outcome measures

1. Self esteem: using Piers Harris questionnaire at 15 months, 3 years and 6 years follow-up
2. Oral aesthetic impact: using OASIS questionnaire at 15 months, 3 years and 6 years follow-up
3. Temporomandibular joint signs or symptoms: clinical examination at 15 months and 3 years

Overall trial start date

01/01/2004

Overall trial end date

01/04/2014

Reason abandoned

Eligibility

Participant inclusion criteria

1. 7-9 years old
2. Class III skeletal pattern
3. 3 or 4 incisors in crossbite

Participant type

Patient

Age group

Child

Gender

Both

Target number of participants

Target = 46. Over recruitment n=73 to allow for dropouts. Final sample size = 65

Participant exclusion criteria

1. Non-white Caucasian origin
2. Cleft lip and or palate or craniofacial syndrome
3. Maxillomandibular plane angle of more than 35 degrees
4. Lower face height greater than 70 mm
5. Previous temporomandibular pain dysfunction syndrome

Recruitment start date

01/01/2004

Recruitment end date

01/12/2006

Locations

Countries of recruitment

United Kingdom

Trial participating centre

Tameside Hospital NHS Foundation Trust (lead site)
OL6 9RW
United Kingdom

Trial participating centre

St Luke's Hospital
Bradford
BD5 ONA
United Kingdom

Trial participating centre

Peterborough Hospital
PE3 9GZ
United Kingdom

Trial participating centre

Kent and Canterbury Hospital
CT1 3NG
United Kingdom

Trial participating centre

Newcastle Dental Hospital
NE2 4AZ
United Kingdom

Trial participating centre

Charles Clifford Dental Hospital
S10 2SZ
United Kingdom

Trial participating centre

Southend Hospital
SSO ORY
United Kingdom

Sponsor information

Organisation

Tameside Hospital NHS Foundation Trust (UK)

Sponsor details

Fountain Street
Ashton under Lyne
OL6 9RW
United States of America

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Industry

Funder name

British Orthodontic Society (UK)

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Funder name

TP Orthodontics Europe

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

Intention to publish date

01/05/2016

Participant level data

Not expected to be available

Results - basic reporting

Publication summary

2010 results (15 months follow-up) in: http://www.ncbi.nlm.nih.gov/pubmed/20805344
2012 results (3 years follow-up) in: http://www.ncbi.nlm.nih.gov/pubmed/22984102
2016 results (6 years follow-up) in: http://www.ncbi.nlm.nih.gov/pubmed/27564126

Publication citations

Additional files

Editorial Notes

30/08/2016: Publication reference added.