Brazzelli, M. (Miriam), McKenzie, L. (Lynda), Fielding, S. (Shona), Fraser, C., Clarkson, J. (Jan), Kilonzo, M. (Mary) and Waugh, Norman. (2006) Systematic review of the effectiveness and cost-effectiveness of HealOzone® for the treatment of occlusal pit/fissure caries and root caries. Health Technology Assessment, Vol.10 (No.16). ISSN 1366-5278

Preview	Text WRAP_Waugh_Healozone.pdf - Published Version Download (415Kb) | Preview
Preview	Text (Cover sheet) WRAP_waugh13_Coversheet_FinalVersion.pdf Download (168Kb) | Preview

Abstract

Objectives: To assess the effectiveness and cost-effectiveness of HealOzone® (CurOzone USA Inc., Ontario, Canada) for the management of pit and fissure caries, and root caries. The complete HealOzone procedure involves the direct application of ozone gas to the caries lesion on the tooth surface, the use of a remineralising solution immediately after application of ozone and the supply of a ‘patient kit’, which consists of toothpaste, oral rinse and oral spray all containing fluoride. Data sources: Electronic databases up to May 2004 (except Conference Papers Index, which were searched up to May 2002). Review methods: A systematic review of the effectiveness of HealOzone for the management of tooth decay was carried out. A systematic review of existing economic evaluations of ozone for dental caries was also planned but no suitable studies were identified. The economic evaluation included in the industry submission was critically appraised and summarised. A Markov model was constructed to explore possible cost-effectiveness aspects of HealOzone in addition to current management of dental caries. Results: Five full-text reports and five studies published as abstracts met the inclusion criteria. The five full-text reports consisted of two randomised controlled trials (RCTs) assessing the use of HealOzone for the management of primary root caries and two doctoral theses of three unpublished randomised trials assessing the use of HealOzone for the management of occlusal caries. Of the abstracts, four assessed the effects of HealOzone for the management of occlusal caries and one the effects of HealOzone for the management of root caries. Overall, the quality of the studies was modest, with many important methodological aspects not reported (e.g. concealment of allocation, blinding procedures, compliance of patients with home treatment). In particular, there were some concerns about the choice of statistical analyses. In most of the full-text studies analyses were undertaken at lesion level, ignoring the clustering of lesions within patients. The nature of the methodological concerns was sufficient to raise doubts about the validity of the included studies’ findings. A quantitative synthesis of results was deemed inappropriate. On the whole, there is not enough evidence from published RCTs on which to judge the effectiveness of ozone for the management of both occlusal and root caries. The perspective adopted for the study was that of the NHS and Personal Social Services. The analysis, carried out over a 5-year period, indicated that treatment using current management plus HealOzone cost more than current management alone for non-cavitated pit and fissure caries (£40.49 versus £24.78), but cost less for non-cavitated root caries (£14.63 versus £21.45). Given the limitations of the calculations these figures should be regarded as illustrative, not definitive. It was not possible to measure health benefits in terms of quality-adjusted life-years, due to uncertainties around the evidence of clinical effectiveness, and to the fact that the adverse events avoided are transient (e.g. pain from injection of local anaesthetic, fear of the drill). One-way sensitivity analysis was applied to the model. However, owing to the limitations of the economic analysis, this should be regarded as merely speculative. For non-cavitated pit and fissure caries, the HealOzone option was always more expensive than current management when the probability of cure using the HealOzone option was 70% or lower. For non-cavitated root caries the costs of the HealOzone comparator were lower than those of current management only when cure rates from HealOzone were at least 80%. The costs of current management were higher than those of the HealOzone option when the cure rate for current management was 40% or lower. One-way sensitivity analysis was also performed using similar NHS Statement of Dental Remuneration codes to those that are used in the industry submission. This did not alter the results for non-cavitated pit fissure caries as the discounted net present value of current management remained lower than that of the HealOzone comparator (£22.65 versus £33.39). Conclusions: Any treatment that preserves teeth and avoids fillings is welcome. However, the current evidence base for HealOzone is insufficient to conclude that it is a cost-effective addition to the management and treatment of occlusal and root caries. To make a decision on whether HealOzone is a cost-effective alternative to current preventive methods for the management of dental caries, further research into its clinical effectiveness is required. Independent RCTs of the effectiveness and cost-effectiveness of HealOzone for the management of occlusal caries and root caries need to be properly conducted with adequate design, outcome measures and methods for statistical analyses.

Item Type:	Journal Article
Subjects:	R Medicine > RK Dentistry
Divisions:	Faculty of Medicine > Warwick Medical School > Warwick Evidence Faculty of Medicine > Warwick Medical School > Health Sciences
Library of Congress Subject Headings (LCSH):	Dental caries -- Treatment, Ozone -- Therapeutic use -- Effectiveness
Journal or Publication Title:	Health Technology Assessment
Publisher:	NIHR Health Technology Assessment programme
ISSN:	1366-5278
Date:	2006
Volume:	Vol.10
Number:	No.16
Status:	Peer Reviewed
Publication Status:	Published
Access rights to Published version:	Restricted or Subscription Access
Funder:	NIHR Health Technology Assessment Programme (Great Britain)
References:	1. Modernising NHS Dentistry – implementing the NHS Plan. London: Department of Health; 2000. 2. Marthaler TM, O’Mullane DM, Vrbic V. The prevalence of dental caries in Europe 1990–1995. ORCA Saturday afternoon symposium 1995. Caries Res 1996;30:237–55. 3. Children’s Dental Health in the United Kingdom 2003. Obvious decay experience in children’s teeth: preliminary findings. London: Department of Health; 2004. 4. Third National Health and Nutrition Examination survey (NHANES III). National Center for Health Statistics, Department of Health and Human Services. URL: from:http://www.cdc.gov/nchs/ about/major/nhanes/datalink.htm#NHANESIII. Accessed July 2004. 5. Sweeney PC, Nugent Z, Pitts NB. Deprivation and dental caries status of 5-year-old children in Scotland. Community Dent Oral Epidemiol 1999; 27:152–9. 6. Murray JJ, Pitts NB. Trends in oral health. In: Pine CM, editor. Community oral health. Oxford: Butterworth Heinemann; 1996. pp. 126–46. 7. Office for Population Censuses and Surveys. Children’s dental health in the United Kingdom 1993. London: HMSO; 1994. 8. Kelly M, Walker A. Adult Dental Health Survey: oral health in the United Kingdom 1998. London: Department of Health; 2000. 9. Ekstrand KR, Ricketts DNJ, Kidd EAM, Qvist V, Schou S. Detection, diagnosing, monitoring and logical treatment of occlusal caries in relation to lesion activity and severity: an in vivo examination with histological validation. Caries Res 1998; 32:247–54. 10. Ricketts DN, Kidd EA, Liepins PJ, Wilson RF. Histological validation of electrical resistance measurements in the diagnosis of occlusal caries. Caries Res 1996;30:148–55. 11. Chestnutt IG, Schafer F, Jacobson AP, Stephen KW. The influence of toothbrushing frequency and postbrushing rinsing on caries experience in a caries clinical trial. Community Dent Oral Epidemiol 1998; 26:406–11. 12. Beal JF, James PM, Bradnock G, Anderson RJ. The relationship between dental cleanliness, dental caries incidence and gingival health. A longitudinal study. Br Dent J 1979;146:111–14. 13. Lewis DW, Ismail AI. Periodic health examination, 1995 update: 2. Prevention of dental caries. The Canadian Task Force on the Periodic Health Examination. CMAJ 1995;152:836–46. 14. Kidd E, Nyvad B. Caries control for the individual patient. In: Fejerskov O, Kidd E, editors. Dental caries: the disease and its clinical management. Oxford: Blackwell Munksgaard; 2003. pp. 303–11. 15. Kleijnen J, McDonagh M, Misso K, Whiting P, Wilson P, Chestnutt I, et al. Fluoridation of drinking water: a systematic review of its efficacy and safety. CRD Report 18. York: NHS Centre for Reviews and Dissemination; 2000. 16. McDonagh MS, Whiting PF, Wilson PM, Sutton AJ, Chestnutt I, Cooper J, et al. Systematic review of water fluoridation. BMJ 2000;321:855–9. 17. Marinho VC, Higgins JP, Logan S, Sheiham A. Fluoride varnishes for preventing dental caries in children and adolescents. Cochrane Database Syst Rev 2002; Issue 1. Art. No. CD002279. DOI 10.1002/14651858.CD002279. 18. Marinho VC, Higgins JP, Logan S, Sheiham A. Fluoride gels for preventing dental caries in children and adolescents. Cochrane Database Syst Rev 2002; Issue 1. Art. No. CD002280. DOI 10.1002/14651858.CD002280. 19. Marinho VC, Higgins JP, Logan S, Sheiham A. Topical fluoride (toothpastes, mouthrinses, gels or varnishes) for preventing dental caries in children and adolescents. Cochrane Database Syst Rev 2003; Issue 4. Art. No. CD002782. DOI 10.1002/14651858.CD002782. 20. Marinho VC, Higgins JP, Logan S, Sheiham A. Fluoride toothpastes for preventing dental caries in children and adolescents. Cochrane Database Syst Rev 2003; Issue 1. Art. No. CD002278. DOI 10.1002/14651858.CD002278. 21. Marinho VC, Higgins JP, Logan S, Sheiham A. Fluoride mouth rinses for preventing dental caries in children and adolescents. Cochrane Database Syst Rev 2003; Issue 3. Art. No. CD002284. DOI 10.1002/14651858.CD002284. 22. Marinho VC, Higgins JP, Logan S, Sheiham A. One topical fluoride (toothpastes, or mouth rinses, or gels, or varnishes) versus another for preventing dental caries in children and adolescents. Cochrane Database Syst Rev 2004; Issue 1. Art. No. CD002780. DOI: 10.1002/14651858.CD002780.pub2. 23. Clarkson JE, Ellwood RP, Chandler RE. A comprehensive summary of fluoride dentifrice caries clinical trials. Am J Dent 1993;6 (Special No.): S59–106. 24. Biesbrock AR, Gerlach RW, Bollmer BW, Faller RV, Jacobs SA, Bartizek RD. Relative anti-caries efficacy of 1100, 1700, and 2800 ppm fluoride ion in a sodium fluoride dentifrice over 1 year. Community Dent Oral Epidemiol 2001;29:382–9. 25. Ripa LW. A critique of topical fluoride methods (dentifrices, mouthrinses, operator-applied, and self-applied gels) in an era of decreased caries and increased fluorosis prevalence. J Public Health Dent 1991;1:23–41. 26. Bader JD, Shugars DA, Bonito AJ. A systematic review of selected caries prevention and management methods. Community Dent Oral Epidemiol 2001;29:399–411. 27. Ellwood R, Fejerskov O. Clinical use of fluoride. In Fejerskov O, Kidd E, editors. Dental caries: the disease and its clinical management. Oxford: Blackwell Munksgaard; 2003. pp. 189–222. 28. Diagnosis and management of dental caries throughout life. NIH Consensus Statement 26–28 March 2001;18(1):1–30. 29. Handelman SL. Effect of sealant placement on occlusal caries progression. Clinical Preventive Dentistry 1982;4(5):11–16. 30. Mertz-Fairhurst EJ, Curtis JW Jr, Ergle JW, Rueggeberg FA, Adair SM. Ultraconservative and cariostatic sealed restorations: results at year 10. J Am Dent Assoc 1998;129:55–66. 31. Ripa LW. Sealants revisited: an update of the effectiveness of pit-and-fissure sealants. Caries Res 1993;27 Suppl 1:77–82. 32. Ahovuo-Saloranta A, Hiiri A, Nordblad A, Worthington HV, Makela M. Pit and fissure sealants for preventing dental decay in the permanent teeth of children and adolescents. Cochrane Database Syst Rev 2004; Issue 3. Art. No. CD001830. DOI 10.1002/14651858.CD001830.pub2. 33. Dental Practice Board. Dental review of the general and personal dental services of the NHS. 2002–2003 [monograph on the Internet]. URL: http://www.dpb.nhs.uk/. Accessed July 2004. 34. Verhagen AP. The Delphi list: a criteria list for quality assessment of randomized clinical trials for conducting systematic reviews developed by the Delphi consensus. J Clin Epidemiol 1998; 51:1235–41. 35. Holmes J. Clinical reversal of root caries using ozone, double-blind, randomised, controlled 18-month trial. Gerodontology 2003;20:106–14. 36. Baysan A, Lynch E. Management of root caries using ozone. KaVo Dental Ltd website. URL: http://www.kavo.com/forum/upfiles/4/ Db84539.pdf. Accessed April 2004. 37. Abu-Naba’a LA. Management of primary occlusal pit and fissure caries using ozone [PhD thesis]. Queen’s University Belfast; 2003. 38. Abu-Salem O. Reversal of occlusal caries in primary teeth [MPhil thesis]. Queen’s University Belfast; 2004. 39. Holmes J. Ozone treatment of root caries after 18-months. IADR/AADR/CADR 82nd Annual Conference, Honolulu, Hawaii, March 2004 [conference proceedings on the Internet]. URL: http://iadr.confex.com/iadr/2004Hawaii/ techprogram/abstract_47251.htm. 40. Holmes J. Ozone treatment of root caries after 21- months. BSDR Annual Scientific Meeting, Birmingham, UK, April 2004 [Conference proceedings on the Internet]. URL: http://iadr.confex.com/iadr/bsdr04/techprogram/ abstract_49444.htm. 41. Baysan A, Lynch E. Clinical reversal of root caries using ozone. IADR/AADR/CADR 80th Annual Conference, San Diego, California, March 2002 [conference proceedings on the internet]. URL: http://iadr.confex.com/iadr/2002SanDiego/ techprogram/abstract_20439.htm. 42. Baysan A. Management of primary root caries using ozone therapies [PhD Thesis]. University of London; 2002. 43. Baysan A, Lynch E. 12-month assessment of ozone on root caries. 81st Annual Conference of IADR, Goteborg, Sweden, June 2003 [conference proceedings on the Internet]. URL: http://iadr.confex.com/iadr/2003Goteborg/ techprogram/abstract_36145.htm. 44. Baysan A, Lynch E. Clinical assessment of ozone on root caries. IADR/AADR/CADR 82nd Annual Conference, Honolulu, Hawaii, March 2004 [conference proceedings on the Internet]. URL: http://iadr.confex.com/iadr/2004Hawaii/ techprogram/abstract_47326.htm. 45. Abu-Naba’a LA, Al Shorman HM, Stevenson M, Lynch E. Ozone treatment of pit and fissure caries: 6-month results. 32nd Annual Meeting of AADR, San Antonio, Texas, March 2003 [conference proceedings on the Internet]. URL: http://iadr.confex.com/iadr/2003SanAnton/ techprogram/abstract_27269.htm. 46. Abu-Naba’a LA, Al Shorman HM, Lynch E. Ozone treatment of primary occlusal pit and fissure caries: 12 month clinical severity changes. Caries Res 2003; 37:272. 47. Abu-Naba’a LA, Al Shorman HM, Lynch E. Ozone treatment of primary occlusal pit and fissure caries: 12 month electrical impedance results and clinical implications. Caries Res 2003;37:272. 48. Abu-Naba’a LA, Al Shorman HM. 6-months fissure sealant retention over ozone-treated occlusal caries. IADR/AADR/CADR 82nd Annual Conference, Honolulu, Hawaii, March 2004 [conference proceedings on the Internet]. URL: http://iadr.confex.com/iadr/2004Hawaii/ techprogram/abstract_45125.htm. 49. Abu-Naba’a LA, Al Shorman HM, Lynch E. Ozone management of occlusal pit & fissure caries (PFC): 12 month review. DentalOzone website. London: Dental Clinique. URL: http://www.dentalozone.co.uk/ research4.html. 50. Abu-Naba’a LA, Al Shorman HM, Lynch E. Ozone efficacy in the treatment of pit and fissure caries. J Dent Res 2003;82(Special Issue C):C-535. 51. Abu-Naba’a LA, Al Shorman HM, Lynch E. Clinical indices changes in ozone treatment of pit and fissure caries. 32nd Annual Meeting of AADR, San Antonio, Texas, March 2003 [conference proceedings on the Internet]. URL: http://iadr.confex.com/iadr/2003SanAnton/ techprogram/abstract_27273.htm. 52. Abu-Naba’a LA, Al Shorman HM, Lynch E. 6-month clinical indices changes after ozone treatment of pit and fissure caries (PFC). 81st Annual Conference of IADR, Goteberg, Sweden, June 2003 [conference proceedings on the Internet]. URL: http://iadr.confex.com/iadr/ 2003Goteborg/techprogram/abstract_35236.htm. 53. Holmes J, Lynch E. Reversal of occlusal caries using air abrasion, ozone and sealing. IADR/AADR/CADR 82nd Annual Conference, Honolulu, Hawaii, March 2004 [conference proceedings on the Internet]. URL: http://iadr.confex.com/iadr/2004Hawaii/ techprogram/abstract_47218.htm. 54. Holmes J. Clinical reversal of occlusal pit and fissure caries using ozone. 81st Annual Conference of the International Association for Dental Research, Goteberg, Sweden, June 2003. 55. Hamid A. Clinical reversal of occlusal pit and fissure caries using ozone. IADR/AADR/CADR 82nd Annual Conference, Honolulu, Hawaii, March 2004 [conference proceedings on the Internet]. URL: from: http://iadr.confex.com/iadr/2004Hawaii/ techprogram/abstract_47414.htm. 56. Megighian GD, Bertolini L. In-vivo reversal of occlusal caries with ozone after six months. DentalOzone website. London: Dental Clinique. URL: http://www.dentalozone.co.uk/research8.html. Accessed August 2004. 57. Lynch E, Johnson J, Johnson J. Clinical reversal of root caries using ozone. DentalOzone website. London: Dental Clinique. URL: http://www.dentalozone.co.uk/research7.html. Assessed August 2004. 58. Kuhnisch J, Ziehe A, Brandstadt A, Heinrich- Weltzien R. An in vitro study of the reliability of DIAGNOdent measurements. J Oral Rehabil 2004; 31:895–9. 59. Macfarlane TV, Worthington HV. Some aspects of data analysis in dentistry. Community Dent Health 1999;16:216–19. 60. Rickard GD, Richardson R, Johnson T, McColl D, Hooper L. Ozone therapy for the treatment of dental caries. Cochrane Database Syst Rev 2004; Issue 3. Art. No. CD004153. DOI 10.1002/14651858.CD004153.pub2. 61. Drummond M, O’Brien B, Stoddard G, Torrance G. Critical assessment of economic evaluation. Methods for the economic evaluation of health care programmes. Oxford: Oxford University Press; 1997. pp. 27–51. 62. Johnson N, Johnson J, Lynch E. Cost benefit assessment of a novel ozone delivery system vs conventional treatment. 32nd Annual Meeting of AADR, San Antonio, Texas, March 2003 [conference proceedings on the Internet]. URL: http://iadr.confex.com/iadr/2003SanAnton/ techprogram/abstract_27588.htm. 63. Domingo H, Holmes J, Abu-Naba’a LA, Al Shorman HM, Baysan A, Freeman R. Economic savings treating root caries with ozone. DentalOzone website. URL: www.dentalozone.co.uk/research6.html. Accessed August 2004. 64. Amendment 92 to the Statement of Dental Remuneration [document on the Internet]. UK Department of Health. URL: http://www.dh.gov.uk/assetRoot/ 04/08/11/28/04081128.pdf. Accessed July 2004. 65. General dental services statistics. Dental Practice Board website. URL: http://www.dpb.nhs.uk/gds/ index.shtml. Assessed July 2004. 66. NHS Centre for Reviews and Dissemination. Dental restorations: what type of filling? Effective Health Care 1999;5(2):1–12. 67. Florio FM, Pereira AC, Meneghim MC, Ramacciato JC. Evaluation of non-invasive treatment applied to occlusal surfaces. Journal of Dentistry for Children 2001;68:326–31. 68. Qvist V, Laurberg L, Poulsen A, Teglers PT. Eight-year study on conventional glass ionomer and amalgam restorations in primary teeth. Acta Odontol Scand 2004;62:37–45. 69. Vilkinis V, Horsted-Bindslev P, Baelum V. Two-year evaluation of class II resin-modified glass ionomer cement/composite open sandwich and composite restorations. Clinical Oral Investigation 2000;4:133–9. 70. Qvist V, Laurberg L, Poulsen A, Teglers PT. Longevity and cariostatic effects of everyday conventional glass-ionomer and amalgam restorations in primary teeth: three-year results. J Dent Res 1997;76:1387–96. 71. Baysan A, Lynch E. Effect of ozone on the oral microbiota and clinical severity of primary root caries. American Journal Dentistry 2004;17:56–60. 72. Morrison R, Lynch E. Remineralization of occlusal pit and fissure caries after using ozone. 32nd Annual Meeting of AADR, San Antonio, Texas, March 2003 [conference proceedings on the Internet]. URL: from:http://iadr.confex.com/iadr/ 2003SanAnton/techprogram/abstract_27482.htm. 73. Stinson P, Al Shorman HM, Abu-Naba’a LA. Lynch E. Clinical reversal of occlusal pit and fissure caries after using ozone. 32nd Annual Meeting of AADR, San Antonio, Texas, March 2003 [conference proceedings on the Internet]. URL: http://iadr.confex.com/iadr/2003SanAnton/ techprogram/abstract_27499.htm. 74. Cronshaw MA. Treatment of primary occlusal pit and fissure caries with ozone: six-month results. 81st Annual Conference of the International Association for Dental Research, Goteberg, Sweden, June 2003 [conference proceedings on the Internet]. URL: http://iadr.confex.com/iadr/ 2003Goteborg/techprogram/abstract_34889.htm. 75. Domingo H, Abu-Naba’a LA, Al Shorman HM, Holmes J, Marashdeh M, Abu-Salem O, et al. Reducing barriers to care in patients managed with ozone. 32nd Annual Meeting of AADR, San Antonio, Texas, March 2003 [conference proceedings on the Internet]. URL: http://iadr.confex.com/iadr/2003SanAnton/ techprogram/abstract_27392.htm. 76. Holmes J, Lynch E. Clinical reversal of occlusal fissure caries using ozone. 81st Annual Conference of the International Association for Dental Research, Goteberg, Sweden, June 2003 [conference proceedings on the Internet]. URL: http://iadr.confex.com/iadr/2003Goteborg/ techprogram/abstract_36308.htm. 77. Megighian GD, Bertolini L, De Pieri A, Lynch E. In-vivo treatment of occlusal caries with ozone: one and two months effect with light induced fluorescence (QLF) as diagnostic methods. 81st Annual Conference of the International Association for Dental Research, Goteberg, Sweden, June 2003 [conference proceedings on the Internet]. URL: http://iadr.confex.com/iadr/2003Goteborg/ techprogram/abstract_36918.htm. 78. Healozone Users Congresses. July 2003 [document on the Internet]. HealOzone website. URL: http://www.the-o-zone.cc/O3cong.doc. Accessed April 2004. 79. National Institute for Clinical Excellence. Guide to the methods of technology appraisal (reference N0515). London: NICE, 2004. 80. Primary dental care services in England & Wales [document on the Internet]. London: Audit Commission; 2002. URL: http://www.auditcommission. gov.uk/. Assessed August 2004. 81. NHS Dentistry: next steps in local commissioning [document on the Internet]. London: UK Department of Health; 2004. URL: http://www.dh.gov.uk/assetRoot/ 04/08/68/59/04086859.pdf. Accessed August 2004. 82. Axelsson P, Nystrom B, Lindhe J. The long-term effect of a plaque control program on tooth mortality, caries and periodontal disease in adults. Results after 30 years of maintenance. J Clin Periodontol 2004;31:749–57. 83. Moher D, Schulz KF, Altman D, for the CONSORT Group. The CONSORT statement: revised recommendations for improving the quality of reports of parallel-group randomized trials. JAMA 2001;285:1987–91.
URI:	http://wrap.warwick.ac.uk/id/eprint/52142

Request changes to a record

Actions (login required)

View Item