TY - JOUR
T1 - Protocol for the Hall Technique study
T2 - A trial to measure clinical effectiveness and cost-effectiveness of stainless steel crowns for dental caries restoration in primary molars in young children
AU - Tonmukayakul, Utsana
AU - Martin, Rachel
AU - Clark, Richard
AU - Brownbill, John
AU - Manton, David
AU - Hall, Martin
AU - Armfield, Jason
AU - Smith, Michael
AU - Shankumar, Ramini
AU - Sivasithamparam, Kavitha
AU - Martin-Kerry, Jacqueline
AU - Calache, Hanny
N1 - Copyright © 2015 Elsevier Inc. All rights reserved.
PY - 2015/9
Y1 - 2015/9
N2 - 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/DESIGN: 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.DISCUSSION: 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.
AB - 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/DESIGN: 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.DISCUSSION: 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.
U2 - 10.1016/j.cct.2015.07.005
DO - 10.1016/j.cct.2015.07.005
M3 - Article
C2 - 26196586
SN - 1551-7144
VL - 44
SP - 36
EP - 41
JO - Contemporary Clinical Trials
JF - Contemporary Clinical Trials
ER -