What is the project?
SIXES is a randomised control trial (RCT). Its aim is to provide new evidence as to whether ‘compensating extraction’, removal of the upper first permanent molar (FPM) to prevent its over-eruption, is necessary when removal of a child’s lower FPM is planned. Although current RCSE guidance recommends this, uncertainty amongst clinicians means that some follow these guidelines and others do not. As a result children may be undergoing additional surgical procedures when there is no benefit. SIXES will investigate the clinical effectiveness, and quality of life for conventional treatment (following the guidelines) compared with removal of lower FPM, but with no compensatory extraction of the upper FPM.
Who is running the trial?
Dr Felicity Borrie & Dr Nicola Innes from the Dundee Dental Hospital and School, University of Dundee are Co-Chief Investigators for the trial, they take responsibility for the conduct of the trial. They both have a track record of dentistry research. The University of Dundee and NHS Tayside are the trial sponsors - they take responsibility for management of the trial. The trial will be overseen by a Trial Management Group, who will meet regularly throughout the trial.
Who is funding the trial?
TheBritish Orthodontic Society Foundation.
Who will approve the trial?
SIXES has been passed by East of Scotland Research Ethics Services. This Committee has given permission for the trial to be conducted across Scotland and England.
What will be the benefits of the trial?
Extraction of FPMs in children is common. Currently dentists and orthodontists face a dilemma in clinical decision-making. This trial will provide evidence to support practice and inform new guidance. Should the trial find the procedure to be unnecessary, it will result in a reduction in the number of teeth extracted, with implications for children and their carers, as well as providers and commissioners of dental services.
Which GDPs and Orthodontists can participate in the trial?
GDPs and practice based Orthodontists who see and treat child patients, and who are willing to undergo study related and general ‘Good Clinical Practice for Research’ (GCP) training. Participating GDPs/ Orthodontists will be asked to recruit between 12 and 20 children over a 24 month period beginning in early Summer 2012.
Which patients are eligible to participate in the study?
The trial will aim to recruit 400 children across England and Scotland, aged 7-11 years requiring extraction of a lower FPM but where the upper FPM(s) has a good prognosis. They will need to be able to co-operate with dental treatment and agree to participate.
What would your practice have to do?
Your practice would be one of several participating in the trial across England and Scotland. One or more GDPs/ Orthodontists would need to agree to recruit children to the study. Recruitment can take place over a two year period. Eligible patients will be invited to participate at their routine assessment appointments. GDPs/ Orthodontists will need to give the patient and carer information about the study and seek their consent to participate.
If patients consent, they will be randomised to either the control group of the study (lower and upper molar extracted) or the intervention group (lower molar only extracted). All participating patients will be asked to complete two questionnaires; have upper and lower impressions taken; and, the GDP/ orthodontist will complete a case report form. The patient will have all other treatment planned and carried out as normal.
Both groups will then be reviewed at routine appointments one year and five years after (or until patients are 14, whichever comes first) the extractions. The review will include the GDP/ Orthodontist completing a questionnaire and taking dental impressions from which a cast will be made by the study team. This will be used to assess the primary outcome of difference in the degree of tipping of the lower second permanent molars between the two groups. Other outcomes include position of the upper FPMs with regard to over-eruption, residual spacing between the lower second permanent molar and lower second premolar, patients self reported experience and quality of life scores.
What support would you and your practice receive for participation?
The study team will deliver a half day training session to all involved practice staff in how to complete the trial effectively and safely. In addition practices will be required to attend a ‘Good Clinical Practice for Research’ (GCP) training day, again to ensure patient safety.
What are the next steps?
When you have had an opportunity to consider the information set out here please contact either Felicity Borrie, Nicola Innes or Steve McSwiggan to raise any queries you have or to express interest in taking the study forward.