title: Protocol for the Hall Technique study: A trial to measure clinical effectiveness and cost-effectiveness of stainless steel crowns for dental caries restoration in primary molars in young children.
abstract: BACKGROUND
  The Hall Technique (HT) is a carious primary molar treatment that does not require local analgesia, carious tissue removal or tooth preparation. The carious lesions in carefully selected teeth are sealed with a stainless steel crown (preformed metal crown). The study aims are to determine the clinical effectiveness, acceptability and cost-effectiveness of the HT for management of carious lesions in young dental patients.
  
  
  METHODS
  Children, aged 3-7years, with a primary molar tooth with a carious lesion extending no further than the middle third of dentine, with no signs or symptoms of pulp inflammation or infection, and attending one of three community agencies are recruited. Target sample size is 220. A control tooth with an intra-coronal restoration is sourced from the same mouth. The primary outcome is the period of time free from further treatment. The assessments are scheduled at 6, 12 and 24months. In addition to the clinical assessment, acceptability of the HT will be assessed via questionnaires among patients and their primary carers at baseline, 6, 12 and 24months. Cost-outcome description and cost-effectiveness analysis from healthcare provider and societal perspective will be conducted.
  
  
  CONCLUSIONS
  The clinical effectiveness, acceptability and cost-effectiveness of the HT in the community dental setting will be evaluated. The results of this study will determine the implementation of HT in the management of dental caries in young children.
authors.affiliation: Deakin Health Economics, Deakin University, Australia; Dental Health Services Victoria, Australia. Electronic address: utsana.tonmukayakul@deakin.edu.au.
authors.forename: Utsana
authors.initials: U
authors.lastname: Tonmukayakul
authors.affiliation: Dental Health Services Victoria, Australia; North Richmond Community Health, Australia.
authors.forename: Rachel
authors.initials: R
authors.lastname: Martin
authors.affiliation: Dental Health Services Victoria, Australia; Australian Health Practitioner Regulation Agency, Australia.
authors.forename: Richard
authors.initials: R
authors.lastname: Clark
authors.affiliation: Melbourne Dental School, University of Melbourne, Australia.
authors.forename: John
authors.initials: J
authors.lastname: Brownbill
authors.affiliation: Melbourne Dental School, University of Melbourne, Australia.
authors.forename: David
authors.initials: D
authors.lastname: Manton
authors.affiliation: North Richmond Community Health, Australia.
authors.forename: Martin
authors.initials: M
authors.lastname: Hall
authors.affiliation: Australian Research Centre for Population Oral Health, University of Adelaide, Australia.
authors.forename: Jason
authors.initials: J
authors.lastname: Armfield
authors.affiliation: Barwon Health, Australia.
authors.forename: Michael
authors.initials: M
authors.lastname: Smith
authors.affiliation: Monash Community Health, Australia.
authors.forename: Ramini
authors.initials: R
authors.lastname: Shankumar
authors.affiliation: North Richmond Community Health, Australia.
authors.forename: Kavitha
authors.initials: K
authors.lastname: Sivasithamparam
authors.affiliation: Dental Health Services Victoria, Australia.
authors.forename: Jacqueline
authors.initials: J
authors.lastname: Martin-Kerry
authors.affiliation: Dental Health Services Victoria, Australia; Melbourne Dental School, University of Melbourne, Australia; School of Dentistry and Oral Health, La Trobe University, Australia.
authors.forename: Hanny
authors.initials: H
authors.lastname: Calache
keywords: Cost-effectiveness analysis; Dental caries; Hall Technique; Preformed metal crown children; Stainless steel crown