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 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 trial start date
01/01/2004
Overall trial end date
01/04/2014
Reason abandoned (if study stopped)
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
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
Basic results (scientific)
Publication list
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