Protocol for “Seal or Varnish?” (SoV) trial: a randomised controlled trial to measure the relative cost and effectiveness of pit and fissure sealants and fluoride varnish in preventing dental decay

BMC Oral Health

Kerenza Hood⁴  Jacqueline Nuttall⁴  Ceri Phillips¹  Deborah Fitzsimmons¹  Sarah Morgan-Trimmer⁵  Simon Murphy⁵  Beverely Withers²  Ceri Hodell²  Lindsay Hunter³  Maria Zeta Morgan³  Nigel Kirkby⁴  Catherine Lisles⁴  Timothy Pickles⁴  Rebecca Playle⁴  Simon Hutchings⁴  Barbara Lesley Chadwick³  Ivor Gordon Chestnutt³ 

[1] Swansea Centre for Health Economics, College of Human and Health Sciences, Swansea University, Swansea University, Singleton Park, Swansea, SA2 8PP, UK;Community Dental Service, Cardiff and Vale University Health Board, Whitchurch Hospital, Cardiff, CF14 7XB, UK;Applied Clinical Research and Public Health, Cardiff University School of Dentistry, Heath Park, Cardiff, CF14 4XY, UK;South East Wales Trials Unit, School of Medicine, Cardiff University, Neuadd Meirionnydd, Heath Park, Cardiff, CF14 4YS, UK;DECIPHer, School of Social Sciences, Cardiff University, 1–3 Museum Place, Cardiff, CF10 3BD, UK

关键词: Oral health;    Preventive dentistry;    Fluoride varnish;    Pit and fissure sealants;    Clinical trial;    Dental caries;   

Others  :  1126297
DOI  :  10.1186/1472-6831-12-51

 received in 2012-11-07, accepted in 2012-11-09,  发布年份 2012

【 摘 要 】

Background

Dental caries remains a significant public health problem, prevalence being linked to social and economic deprivation. Occlusal surfaces of first permanent molars are the most susceptible site in the developing permanent dentition. Cochrane reviews have shown pit and fissure sealants (PFS) and fluoride varnish (FV) to be effective over no intervention in preventing caries. However, the comparative cost and effectiveness of these treatments is uncertain. The primary aim of the trial described in this protocol is to compare the clinical effectiveness of PFS and FV in preventing dental caries in first permanent molars in 6-7 year-olds. Secondary aims include: establishing the costs and the relative cost-effectiveness of PFS and FV delivered in a community/school setting; examining the impact of PFS and FV on children and their parents/carers in terms of quality of life/treatment acceptability measures; and examining the implementation of treatment in a community setting.

Methods/design

The trial design comprises a randomised, assessor-blinded, two-arm, parallel group trial in 6–7 year old schoolchildren. Clinical procedures and assessments will be performed at 66 primary schools, in deprived areas in South Wales. Treatments will be delivered via a mobile dental clinic. In total, 920 children will be recruited (460 per trial arm). At baseline and annually for 36 months dental caries will be recorded using the International Caries Detection and Assessment System (ICDAS) by trained and calibrated dentists. PFS and FV will be applied by trained dental hygienists. The FV will be applied at baseline, 6, 12, 18, 24 and 30 months. The PFS will be applied at baseline and re-examined at 6, 12, 18, 24, and 30 months, and will be re-applied if the existing sealant has become detached/is insufficient. The economic analysis will estimate the costs of providing the PFS versus FV. The process evaluation will assess implementation and acceptability through acceptability scales, a schools questionnaire and interviews with children, parents, dentists, dental nurses and school staff. The primary outcome measure will be the proportion of children developing new caries on any one of up to four treated first permanent molars.

Discussion

The objectives of this study have been identified by the National Institute for Health Research as one of importance to the National Health Service in the UK. The results of this trial will provide guidance on which of these technologies should be adopted for the prevention of dental decay in the most susceptible tooth-surface in the most at risk children.

Trial registrations

ISRCTN ref: ISRCTN17029222 EudraCT: 2010-023476-23 UKCRN ref: 9273

【 授权许可】

   
2012 Chestnutt et al.; licensee BioMed Central Ltd.

【 图 表 】

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【 参考文献 】

• [1]Pitts NB, Chestnutt IG, Evans D, White D, Chadwick B, Steele JG: The dentinal caries experience of children in the United Kingdom, 2003. Br Dent J 2006, 200:313-320.
• [2]Locker D: Deprivation and oral health: a review. Community Dent Oral Epidemiol 2000, 28:161-169.
• [3]Sweeney PC, Nugent Z, Pitts NB: Deprivation and dental caries status of 5-year old children in Scotland. Community Dent Oral Epidemiol 1999, 27:152-159.
• [4]Chestnutt IG, Schafer F, Jacobson APM, Stephen KW: Incremental susceptibility of individual tooth surfaces to dental caries in Scottish adolescents. Comm Dent Oral Epidemiol 1996, 24:11-16.
• [5]Hopcraft MS, Morgan MV: Pattern of dental caries experience on tooth surfaces in an adult population. Community Dent Oral Epidemiol 2006, 34:174-183.
• [6]Ahovuo-Saloranta A, Hiiri A, Norblad A, Mäkelä A, Worthington HV: Pit and fissure sealants for preventing decay in the permanent teeth of children and adolescents. Cochrane Database Syst Rev 2008.
• [7]Marhino VCC, Higgins JPT, Logan S, Sheiham A: Fluoride varnishes for preventing dental caries in children and adolescents. Cochrane Database Syst Rev 2002.
• [8]Bhuridej P, Kuthy RA, Flach SD, Heller KE, Dawson DV, Kanellis MJ, Damiano PC: Four-year cost-utility analyses of sealed and nonsealed first permanent molars in Iowa Medicaid-enrolled children. J Public Health Dent 2007, 67:191-198.
• [9]Hiiri A, Ahouvo-Saloranta A, Nordblad A, Mäkelä A: Pit and fissure sealants versus fluoride varnishes for preventing dental decay in children and adolescents. Cochrane Database Syst Rev 2010.
• [10]Scottish Intercollegiate Guidelines Network: Preventing Dental Caries inChildren at High Caries Risk - Targeted prevention of dental caries in the permanent teeth of 6–16 year olds presenting for dental care. Edinburgh: SIGN; 2000.
• [11]Nunn JH, Murray JJ, Smallridge J: Fissure Sealants. Int J Paediatr Dent 2000, 10:174-177.
• [12]Pitts N: “ICDAS”–an international system for caries detection and assessment being developed to facilitate caries epidemiology, research and appropriate clinical management. Community Dent Health 2004, 21:193-198.
• [13]International Caries Detection and Assessment System Coordinating Committee: ICDAS II International Caries assessment and Detection System. http://www.icdas.org/assets/downloads/Appendix.pdf webcite
• [14]Curtis L: Unit costs of health and social care. PSSRU: University of Kent; 2011.
• [15]NHS Reference costs. 2010–11. http://www.nelm.nhs.uk/en/NeLM-Area/News/2011---November/18/Publication-of-2010-11-reference-costs/ webcite
• [16]British National Formulary. http://www.bnf.org webcite
• [17]Stevens KJ: Developing a descriptive system for a new preference-based measure of health related quality of life for children. Qual Life Research 2009, 18:1105-1113.
• [18]Stevens K: Valuation of the child health utility 9D index. Pharmacoeconomics 2012, 30:729-47.
• [19]Hawkins R, Noble J, Locker D, Wiebe D, Murray H, Wiebe P, Frosina C, Clarke M: A comparison of the costs and patient acceptability of professionally applied topical fluoride foam and varnish. J Public Health Dent 2004, 64:106-110.
• [20]Andrews FM, Withey SB: Social indicators of well-being: Americans’ perceptions of Life Quality. New York: Plenum Press; 1976.
• [21]Marshman Z, Hall M: Oral health research with children. Int J Paediatr Dent 2008, 18:235-242.
• [22]Altman DG, Bland JM: Treatment allocation by minimisation. BMJ 2005, 330:843.
• [23]Treasure ET, Jones RJ, Chadwick BL, Brown R: Children’s cohort study: oral health in fluoridated and non-fluoridates areas. J Dent Res 2005, 84(Spec Iss A):0014.
• [24]Medical Research Council / Department of Health / Medicines and Healthcare Regulatory Agency. 2011. http://www.mhra.gov.uk/home/groups/l-ctu/documents/websiteresources/con111784.pdf webcite
• [25]Medicine and Healthcare Regulatory Agency: MHRA produced FAQs for Risk Adaptive Approach. 2011. http://www.forums.mhra.gov.uk/showthread.php?39-MHRA-produced-FAQs-for-Risk-Adaptive-Approach&p=1194&viewfull=1#post1194 webcite
• [26]Declaration of Helsinki: Declaration of Helsinki. 2008. http://www.wma.net/en/30publications/10policies/b3/17c.pdf webcite
• [27]ICH Harmonised Tripartite Guideline for Good Clinical Practice. http://www.ich.org/fileadmin/Public_Web_Site/ICH_Products/Guideli nes/Efficacy/E6_R1/Step4/E6_R1__Guideline.pdf webcite
• [28]The Medicines for Human Use (Clinical Trials Regulations 2004). http://www.mhra.gov.uk/Howweregulate/Medicines/Licensingofmedicines/Clinicaltrials/Legislation/ImplementationofClinicalTrialsDirectiveintheUK/index htm webcite
• [29]Welsh Assembly Government: Research Governance Framework for Health and Social Care. 2nd edition. 2009. Health http://www.cardiff.ac.uk/racdv/resgov/Resources/Research%20Governance%20Framework%20Wales%202009.pdf webcite
• [30]Welsh Government: Welsh Index of Multiple Deprivation. 2011. http://wales.gov.uk/topics/statistics/theme/wimd/wimd2011/?lang=en webcite
• [31]British Association for the Study of Community Dentistry - Dental Caries Experience of 5 year-old children in Great Britain 2005/ 2006. http://www.bascd.org webcite
• [32]Morris J, Pendry L, Harker R: Children’s Dental Health Survey 2003: Patterns of care and service use. Office for National Statistics; 2004. http://www.statistics.gov.uk/downloads/cdh4_Patterns_of_care.pdf webcite