A clinical trial to assess the effectiveness of miniplate surgical treatment to bring the upper jaw forwards in 11-14 years old children
| ISRCTN | ISRCTN93900866 |
|---|---|
| DOI | https://doi.org/10.1186/ISRCTN93900866 |
| IRAS number | 160532 |
| Secondary identifying numbers | Protocol version 1. 2/6/14, Tameside Hospital Reference: MC/2014/323, IRAS 160532 |
- Submission date
- 02/09/2014
- Registration date
- 19/09/2014
- Last edited
- 29/10/2024
- Recruitment status
- No longer recruiting
- Overall study status
- Completed
- Condition category
- Oral Health
Plain English summary of protocol
Background and study aims
Children with a lower jaw protruding forward of the upper jaw have what is called a class III skeletal pattern. In some cases, it is caused by the upper jaw being set too far back. The treatment in such cases is to bring the upper jaw forward to correct the reverse bite. Patients are not usually offered corrective treatment until their general and facial growth is complete at around 17-18 years of age, at which point they may be offered orthognathic (jaw) surgery to correct the position of the jaw. The surgery involves a controlled break of the upper and lower jaw from inside the mouth which are then screwed into place to hold the jaws into their new position. There is an early treatment option, for children under the age of 10 that may prevent them from having to undergo the surgery when they are older. This means wearing reverse headgear, which brings the top jaw and teeth forwards over time and has a 70% success rate, but this option only works for children under the age of 10. There is, however, another option for 11-14 year olds. This is called Bone Anchored Maxillary Protection (BAMP). It involves places small metal plates (miniplates) from inside the mouth into the front part of the cheekbone next to the upper molars on each side. Further miniplates are positioned near the front of the lower jaw. Elastics are then attached from the upper to the lower plates, via hooks, to bring the upper jaw and teeth forwards and correct the class III skeletal pattern. At the moment, BAMP is not used routinely used in the UK. Here, we want to see how well it performs compared with a no treatment (control group) to see whether it reduces the need for orthognathic surgery at a later date.
Who can participate?
Children aged between 11-14, with a class III skeletal pattern and a reverse bite.
What does the study involve?
Participants are randomly allocated into one of two groups. Those in group 1 undergo BAMP surgery. Those in group 2 are given no treatment. The success of the treatment will be assessed according to how much the upper jaw moves to correct the reverse bite and whether orthognathic surgery is needed at a later date. All participants are followed up at 1 year and 3 years after the start of the trial to compare the outcomes for each group.
What are the possible benefits and risks of participating?
Possible benefits of BAMP include avoiding orthognathic surgery at a later date. The treatment is also considerably cheaper than orthognathic surgery and is a 30 minute daycase procedure rather than a treatment requiring a 3 day stay in hospital.
Where is the study run from?
The trial is multicentre with proposed sites: Tameside Hospital NHS Foundation Trust (Lead site), University Hospital of south Manchester (Wythenshawe Hospital), Bradford Royal Infirmary, Sheffield Dental Hospital, Newcastle Dental Hospital, Peterborough General Hospital, Southend Hospital, Kent and Canterbury Hospital (UK)
When is the study starting and how long is it expected to run for?
January 2015 to October 2022
Who is funding the study?
DB Orthodontics (UK)
Who is the main contact?
Dr Nicola Mandall
(see contact details below)
Contact information
Scientific
Orthodontic Department
Tameside Hospital NHS Foundation Trust
Fountain Street
Ashton under Lyne
Lancashire
Lancashire
OL6 9RW
United Kingdom
Study information
| Study design | Multicentre randomized 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 to request a patient information sheet |
| Scientific title | A multicentre randomised clinical trial to investigate whether Bone Anchored Maxillary Protraction (BAMP) reduces the need for orthognathic (facial) surgery |
| Study acronym | BAMP |
| Study objectives | Null hypothesis: There is no difference in the effectiveness of BAMP versus no treatment/control group in terms of: need for later orthognathic facial surgery, skeletal forward movement of the maxilla (upper jaw), correction of reverse overjet, facial profile improvement. |
| Ethics approval(s) | NRES committee North West Greater Manchester Central, 19/02/2015, ref: 15/NW/0022 |
| Health condition(s) or problem(s) studied | Oral and maxillofacial surgery and orthodontics |
| Intervention | Group 1: BAMP surgery Group 2: Control/no treatment BAMP consists of small metal plates that are inserted from inside the mouth into the front part of the cheekbone bone next to the upper molars on each side. Further miniplates are positioned into the bone down in the lower canine region near the front of the lower jaw. Elastics are then attached from the upper to the lower plates, via hooks, to bring the upper jaw and teeth forwards and correct the class III skeletal pattern. The miniplates are placed and later removed as a daycase general anaesthetic procedure and the patient wears the elastics for around 6-8 months. |
| Intervention type | Procedure/Surgery |
| Primary outcome measure | 1. Need for orthognathic surgery later 2. Amount of forward movement of the maxilla (upper jaw) to correct the reverse bite 3. Reverse overjet (bite) correction Need for orthognathic surgery will be measured through consultant clinical panel consensus method using patient records. Forward movement of the maxilla will be measured from lateral cephalogram radiographs. Reverse overbite correction will be measured from plaster study models of the patientsÂ’ teeth using a metal ruler. The outcomes will be measured at baseline, 1 and 3 years follow-up. |
| Secondary outcome measures | 1. Facial aesthetic improvement 2. Patient discomfort log following surgery 3. Operating time for the BAMP surgery 4. BAMP - post operative infection rates and plate failure rates Facial aesthetic improvement will be measured using panel consensus of facial profiles photographs. Patient discomfort log will be recorded on a 7 point Likert scale with 1 = no pain at all to 7 severe pain. Operating time for BAMP surgery will be recorded from the theatre time log. Post operative infection rates and plate failure rates will be recorded from the patient notes. The outcomes will be measured at baseline, 1 and 3 years follow-up. |
| Overall study start date | 02/01/2015 |
| Completion date | 01/10/2022 |
Eligibility
| Participant type(s) | Patient |
|---|---|
| Age group | Child |
| Lower age limit | 11 Years |
| Upper age limit | 14 Years |
| Sex | Both |
| Target number of participants | 60 |
| Total final enrolment | 57 |
| Key inclusion criteria | 1. Age 11-14 years old 2. Class III skeletal pattern with reverse bite of at least 1mm 3. Dentally fit 4. Written consent |
| Key exclusion criteria | 1. Cleft lip and or palate or craniofacial syndrome 2. Reverse bite greater than 6mm 3. Lower jaw asymmetric 4. Muscular dystrophy (weakness) 5. Patient smokes |
| Date of first enrolment | 06/07/2015 |
| Date of final enrolment | 01/10/2019 |
Locations
Countries of recruitment
- England
- United Kingdom
Study participating centre
OL6 9RW
United Kingdom
Sponsor information
Hospital/treatment centre
c/o Mrs Margaret Cooper
Tameside Hospital NHS Foundation Trust R+D department
Fountain Street
Ashton under Lyne
Lancashire
OL6 9RW
England
United Kingdom
"ROR" |
https://ror.org/04d713p41 |
|---|
Funders
Funder type
Industry
No information available
Results and Publications
| Intention to publish date | 01/10/2024 |
|---|---|
| Individual participant data (IPD) Intention to share | No |
| IPD sharing plan summary | Not expected to be made available |
| Publication and dissemination plan | Current publication and dissemination plan: Submitted to the Journal of Orthodontics in August 2023 Previous publication and dissemination plan: To be confirmed at a later date |
| IPD sharing plan | The datasets generated during and/or analysed during the current study are not expected to be made available. The data will be held at Tameside and Glossop Integrated Care NHS Foundation Trust and copied to the R+D dept for electronic archiving. |
Study outputs
| Output type | Details | Date created | Date added | Peer reviewed? | Patient-facing? |
|---|---|---|---|---|---|
| HRA research summary | 28/06/2023 | No | No | ||
| Results article | 06/06/2024 | 29/10/2024 | Yes | No |
Editorial Notes
29/10/2024: Publication reference added.
16/10/2023: Publication and dissemination plan updated. The intention to publish date was changed from 01/10/2023 to 01/10/2024.
19/10/2022: No further updates are available at the present time. The researchers are currently completing data entry and still plan for final publication by October 2023. IPD sharing statement added.
17/02/2020: The IRAS number has been added.
12/02/2020: The following changes have been made:
1. The recruitment end date has been changed from 31/01/2020 to 01/10/2019.
2. The overall trial end date has been changed from 31/01/2020 to 01/10/2022 and the plain English summary has been updated to reflect this change.
3. The intention to publish date has been added.
4. The total final enrolment number has been added.
24/03/2016: Ethics approval information added.
