Early orthodontic treatment for reverse bite: an orthopaedic facemask treatment for children < 10 years old reduces the need for jaw surgery in the late teens

ISRCTN	ISRCTN10014340
DOI	https://doi.org/10.1186/ISRCTN10014340
Secondary identifying numbers	N/A

Submission date: 22/04/2016
Registration date: 12/05/2016
Last edited: 20/01/2020

Recruitment status: No longer recruiting
Overall study status: Completed
Condition category: Oral Health

Prospectively registered

Protocol

Statistical analysis plan

Results

Individual participant data

Plain English summary of protocol

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

Contact information

Dr Nicky Mandall
Scientific

Tameside Hospital NHS Foundation Trust
Fountain Street
Ashton under Lyne
OL6 9RW
United Kingdom

Phone	+44 (0)161 922 6461
Email	Nicky.mandall@tgh.nhs.uk

Study information

Study design	Interventional multi-centre randomised controlled trial
Primary study design	Interventional
Secondary study design	Randomised controlled trial
Study setting(s)	Hospital
Study type	Treatment
Participant information sheet	Not available in web format, please use the contact details below to request a patient information sheet
Scientific title	Early class III protraction facemask treatment reduces the need for orthognathic surgery: a multicentre, two-arm, parallel randomised controlled trial
Study acronym	Early class III trial
Study objectives	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(s)	North West MREC, 18/02/2003, MREC 03/8/2
Health condition(s) or problem(s) studied	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
Pharmaceutical study type(s)
Phase
Drug / device / biological / vaccine name(s)
Primary outcome measure	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 study start date	01/01/2004
Completion date	01/04/2014

Eligibility

Participant type(s)	Patient
Age group	Child
Lower age limit	7 Years
Upper age limit	9 Years
Sex	Both
Target number of participants	Target = 46. Over recruitment n=73 to allow for dropouts. Final sample size = 65
Key inclusion criteria	1. 7-9 years old 2. Class III skeletal pattern 3. 3 or 4 incisors in crossbite
Key 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
Date of first enrolment	01/01/2004
Date of final enrolment	01/12/2006

Locations

Countries of recruitment

England
United Kingdom

Study participating centres

Tameside Hospital NHS Foundation Trust (lead site)

OL6 9RW
United Kingdom

St Luke's Hospital

Bradford
BD5 ONA
United Kingdom

Peterborough Hospital

PE3 9GZ
United Kingdom

Kent and Canterbury Hospital

CT1 3NG
United Kingdom

Newcastle Dental Hospital

NE2 4AZ
United Kingdom

Charles Clifford Dental Hospital

S10 2SZ
United Kingdom

Southend Hospital

SSO ORY
United Kingdom

Sponsor information

Tameside Hospital NHS Foundation Trust (UK)
Hospital/treatment centre

Fountain Street
Ashton under Lyne
OL6 9RW
England
United Kingdom

"ROR"	https://ror.org/01knk7v72

Funders

Funder type

Industry

British Orthodontic Society (UK)

No information available

TP Orthodontics Europe

No information available

Results and Publications

Intention to publish date	01/05/2016
Individual participant data (IPD) Intention to share	No
IPD sharing plan summary	Not expected to be made available
Publication and dissemination plan
IPD sharing plan

Study outputs

Output type	Details	Date created	Peer reviewed?	Patient-facing?
Results article	results (15 months follow-up)	01/09/2010	Yes	No
Results article	results (3 years follow-up)	01/09/2012	Yes	No
Results article	results (6 years follow-up)	01/09/2016	Yes	No

Editorial Notes

20/01/2020: Internal review.
30/08/2016: Publication reference added.