title: A new primary dental care service compared with standard care for child and family to reduce the re-occurrence of childhood dental caries (Dental RECUR): study protocol for a randomised controlled trial.
abstract: BACKGROUND
  In England and Scotland, dental extraction is the single highest cause of planned admission to the hospital for children under 11 years. Traditional dental services have had limited success in reducing this disease burden. Interventions based on motivational interviewing have been shown to impact positively dental health behaviours and could facilitate the prevention of re-occurrence of dental caries in this high-risk population. The objective of the study is to evaluate whether a new, dental nurse-led service, delivered using a brief negotiated interview based on motivational interviewing, is a more cost-effective service than treatment as usual, in reducing the re-occurrence of dental decay in young children with previous dental extractions.
  
  
  METHODS
  This 2-year, two-arm, multicentre, randomised controlled trial will include 224 child participants, initially aged 5 to 7 years, who are scheduled to have one or more primary teeth extracted for dental caries under general anaesthesia (GA), relative analgesia (RA: inhalation sedation) or local anaesthesia (LA). The trial will be conducted in University Dental Hospitals, Secondary Care Centres or other providers of dental extraction services across the United Kingdom. The intervention will include a brief negotiated interview (based on the principles of motivational interviewing) delivered between enrollment and 6 weeks post-extraction, followed by directed prevention in primary dental care. Participants will be followed up for 2 years. The main outcome measure will be the dental caries experienced by 2 years post-enrollment at the level of dentine involvement on any tooth in either dentition, which had been caries-free at the baseline assessment.
  
  
  CONCLUSIONS
  The participants are a hard-to-reach group in which secondary prevention is a challenge. Lack of engagement with dental care makes the children and their families scheduled for extraction particularly difficult to recruit to an RCT. Variations in service delivery between sites have also added to the challenges in implementing the Dental RECUR protocol during the recruitment phase.
  
  
  BACKGROUND
  ISRCTN24958829 (date of registration: 27 September 2013), Current protocol version: 5.0.
authors.affiliation: Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Turner Street, Whitechapel, London, E1 2BA, UK. c.m.pine@qmul.ac.uk.|R&D Department, Salford Royal NHS Foundation Trust, Mayo Building, 3rd Floor, Stott Lane, Salford, M6 8HD, UK. c.m.pine@qmul.ac.uk.
authors.forename: Cynthia
authors.initials: C
authors.lastname: Pine
authors.affiliation: Health Psychology and Behavioural Medicine Research Group, School of Psychological Sciences and Health, University of Strathclyde, 40 George Street, Glasgow, G1 1QE, UK. Pauline.adair@strath.ac.uk.
authors.forename: Pauline
authors.initials: P
authors.lastname: Adair
authors.affiliation: Department of Biostatistics, University of Liverpool, Institute of Translational Medicine, Crown Street, Liverpool, L69 3BX, UK. g.burnside@liverpool.ac.uk.
authors.forename: Girvan
authors.initials: G
authors.lastname: Burnside
authors.affiliation: R&D Department, Salford Royal NHS Foundation Trust, Mayo Building, 3rd Floor, Stott Lane, Salford, M6 8HD, UK. Louise.robinson@srft.nhs.uk.
authors.forename: Louise
authors.initials: L
authors.lastname: Robinson
authors.affiliation: Centre for Health Economics and Medicines Evaluation, Ardudwy Hall, Bangor University, Bangor, Gwynedd, LL57 2PZ, UK. r.t.edwards@bangor.ac.uk.
authors.forename: Rhiannon Tudor
authors.initials: RT
authors.lastname: Edwards
authors.affiliation: School of Dentistry, University of Liverpool, Pembroke Place, Liverpool, L3 5PS, UK. Sondos.albadri@liverpool.ac.uk.
authors.forename: Sondos
authors.initials: S
authors.lastname: Albadri
authors.affiliation: NHS Tayside, Tweed Place, Perth, PH1 1TJ, UK. Morag.curnow@nhs.net.
authors.forename: Morag
authors.initials: M
authors.lastname: Curnow
authors.affiliation: North East London NHS Foundation Trust, Tantallon House, Goodmayes Hospital Site, Barley lane, Essex, IG3 8XJ, UK. mghahreman@nhs.net.
authors.forename: Marjan
authors.initials: M
authors.lastname: Ghahreman
authors.affiliation: Kent Community Health NHS Trust, Capital House, Jubillee Way, Faversham, Kent ME, 13 8GD, UK. Mary.henderson3@nhs.net.
authors.forename: Mary
authors.initials: M
authors.lastname: Henderson
authors.affiliation: Salford Royal NHS Foundation Trust, Community Dental Service, Dental Department, Pendleton Gateway, 1 Broadwalk, Salford, M6 5FX, UK. Clare.Malies@srft.nhs.uk.
authors.forename: Clare
authors.initials: C
authors.lastname: Malies
authors.affiliation: Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Turner Street, Whitechapel, London, E1 2BA, UK. f.s.l.wong@qmul.ac.uk.
authors.forename: Ferranti
authors.initials: F
authors.lastname: Wong
authors.affiliation: Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Turner Street, Whitechapel, London, E1 2BA, UK. v.muirhead@qmul.ac.uk.
authors.forename: Vanessa
authors.initials: V
authors.lastname: Muirhead
authors.affiliation: Institute of Dentistry, Barts and The London School of Medicine and Dentistry, Queen Mary University of London, Turner Street, Whitechapel, London, E1 2BA, UK. s.weston-price@qmul.ac.uk.
authors.forename: Sally
authors.initials: S
authors.lastname: Weston-Price
authors.affiliation: Salford Royal NHS Foundation Trust, Community Dental Service, Dental Department, Pendleton Gateway, 1 Broadwalk, Salford, M6 5FX, UK. Hilary.Whitehead@srft.nhs.uk.
authors.forename: Hilary
authors.initials: H
authors.lastname: Whitehead
mesh_terms: D000367:Age Factors; D000758:Anesthesia / Q000379:methods; D002648:Child; D002652:Child Behavior; D002675:Child, Preschool; D002985:Clinical Protocols; D003726:Dental Assistants; D019140:Dental Care for Children / Q000379:methods* / Q000451:nursing; D003731:Dental Caries / Q000175:diagnosis / Q000517:prevention & control* / Q000523:psychology / Q000601:surgery; D003733:Dental Caries Susceptibility; D007722:Health Knowledge, Attitudes, Practice; D006801:Humans; D062405:Motivational Interviewing; D010290:Parents / Q000523:psychology; D010353:Patient Education as Topic; D011313:Preventive Dentistry / Q000379:methods*; D011320:Primary Health Care / Q000379:methods*; D012008:Recurrence; D012107:Research Design; D012307:Risk Factors; D055502:Secondary Prevention / Q000379:methods*; D013997:Time Factors; D014081:Tooth Extraction; D016896:Treatment Outcome; D006113:United Kingdom