Background: Extraction of lower first permanent molars (LFPM) in children is common. There is uncertainty amongst clinicians as to whether ‘compensating extraction' (removal of the upper first permanent molar (UFPM) to prevent its over eruption) is necessary despite current guidelines recommending this. As a result, unnecessary extractions may be carried out or children may fail to receive extractions required to achieve optimal long-term oral health. In addition, the decision to extract fewer or more teeth impacts on management options (local anaesthesia alone, inhalation sedation or general anaesthesia) to support children with surgical procedures.
Objectives: The SIXES (Should I eXtract Every Six) Dental Trial investigates clinical effectiveness and quality of life for conventional treatment (following the guideline of compensation extraction of the UFPM) compared with the alternative intervention (removal of LFPMs but no compensating extraction of the UFPMs).
Method: This is a multi-centre, two-arm parallel-group randomised trial. Practitioners in Primary and Secondary Care settings, reflecting patients' presentation and treatment points, will recruit 400 children (7-11 years) requiring extraction of LFPMs but who have UFPMs of good prognosis. Baseline measures (prior to treatment) and outcome data (one and five years, or when patient is 14 years) will be assessed through study models and child/parent questionnaires.
Result: Primary outcome measure; degree of tipping of lower second permanent molar, (favourable outcome is tipping less than 15°). Secondary outcomes; anaesthetic/sedation used, residual spacing (between lower second premolar and second permanent molar); orthodontic treatment requirement, quality of life, and over-eruption of retained UFPM in intervention group. Assessors will be blinded where possible.
Conclusions: Currently dentists and orthodontists face a dilemma in clinical decision-making in this area of routine dental practise, relying on lowest level evidence, expert opinion. SIXES will provide evidence to support decision-making and inform practise.