title: Should I eXtract Every Six dental trial (SIXES): study protocol for a randomized controlled trial.
abstract: BACKGROUND
  Extraction of lower first permanent molars in children is common. There is uncertainty among clinicians as to whether a 'compensating extraction' (removal of the upper first permanent molar to prevent it over erupting) is necessary despite current guidelines recommending this. As a result, unnecessary dental extractions may be carried out or children may be failing to receive extractions required to achieve optimal long-term oral health. In addition, the decision to extract fewer or more teeth affects management options (local anesthetic injections alone, inhalation sedation or general anesthesia) needed to support the child with the surgical procedure(s).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 upper first permanent molar) compared with the alternative intervention (removal of lower first permanent molars but no extraction of the upper).
  
  
  METHODS
  This is a multicenter, two-arm parallel group randomized clinical trial. Allocation will be web-based randomization. Practitioners in primary and secondary care settings, reflecting the points of presentation and treatment of eligible patients, will recruit 400 children, aged 7 to 11 years requiring extraction of lower first permanent molars but who have upper first permanent molars of good prognosis. Baseline measures (prior to treatment) and outcome data (at one and five years, or when the patient reaches 14 years of age) will be assessed through study models and child/parent questionnaires.The primary outcome measure is degree of tipping of the lower second permanent molar, (favorable outcome is tipping less than 15°).The secondary outcomes are type of anesthetic/sedation used, residual spacing (between lower second premolar and second permanent molar), orthodontic treatment requirement, quality of life, and over-eruption in the intervention group. Assessors will be blinded where possible.
  
  
  CONCLUSIONS
  SIXES dental trial investigates whether compensating extraction of upper first permanent molars should be carried out following loss of lower first permanent molars. Currently dentists and orthodontists face a dilemma in clinical decision-making, relying on the lowest level of evidence - expert opinion. SIXES will provide evidence to support decision-making and inform practices and may result in reduced tooth extractions.
  
  
  BACKGROUND
  Clinical Trials.gov Identifier: NCT01591265.
authors: Dundee Dental Hospital and School, Park Place, University of Dundee, DD1 4HN, Dundee, UK. n.p.innes@dundee.ac.uk
authors: Nicola
authors: N
authors: Innes
authors: Felicity
authors: F
authors: Borrie
authors: David
authors: D
authors: Bearn
authors: Dafydd
authors: D
authors: Evans
authors: Petra
authors: P
authors: Rauchhaus
authors: Steve
authors: S
authors: McSwiggan
authors: Lyndie Foster
authors: LF
authors: Page
authors: Fiona
authors: F
authors: Hogarth
mesh_terms: D000293:Adolescent; D002648:Child; D002985:Clinical Protocols; D003661:Decision Support Techniques; D019229:Dentition, Permanent; D019317:Evidence-Based Medicine; D019983:Guideline Adherence; D006801:Humans; D008963:Molar / Q000601:surgery*; D011183:Postoperative Complications / Q000209:etiology; D017410:Practice Guidelines as Topic; D011788:Quality of Life; D012107:Research Design; D012606:Scotland; D011795:Surveys and Questionnaires; D013997:Time Factors; D014081:Tooth Extraction / Q000009:adverse effects / Q000592:standards; D016896:Treatment Outcome