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Systematic review of the effectiveness and cost effectiveness of HealOzone for the treatment of occlusal pit/fissure caries and root caries.
Howard E. Strassler, DMD
Commentary by Howard E. Strassler, DMD
Brazzelli M, McKenzie L, Fielding S, et al. Health Technol Assess. 2006;10(16):iii-iv, ix-80.
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 remineralizing 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. 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 summarized. A Markov model was constructed to explore possible cost-effectiveness aspects of HealOzone in addition to the current management of caries. Results: Five full-text reports and five studies published as abstracts met the inclusion criteria. The five full-text reports consisted of two randomized controlled trials (RCTs) assessing the use of HealOzone for the management of primary root caries and two doctoral theses of three unpublished randomized trials assessing the use of HealOzone for the management of occlusal caries.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 on 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 (eg, concealment of allocation, blinding procedures, compliance of patients with home treatment). In particular there were some concerns about the choice of statistical analyses.... 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. Conclusion: 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.
Ozone has been shown to be an effective treatment of root caries when used with remineralization solutions. It has been suggested that the application of ozone to the root surface disrupts the acidogenic and aciduric microorganisms responsible for root caries with an additional preventive effect decreasing the regrowth of the organisms over the next 6 months. While ozone treatment may soon be available for use in the United States, it is important to note that, at the time of this commentary, ozone treatment is under review for approval by the FDA.
These two abstracts represent opposite ends of the spectrum for the use of ozone therapy in the treatment of caries. Baysan and Lynch is one of many studies demonstrating the success of ozone treatment for the reversal of root caries. It must be noted that case selection is important. Brazzelli et al is a systematic review that questions the effectiveness of ozone therapy for both occlusal and root caries. A search of the literature produced two additional systematic reviews of ozone therapy that concluded that there was no reliable evidence that ozone gas stops or reverses tooth decay.1,2 In fact, one of the authors of the root caries study reported in another article that ozone treatment of non-cavitated occlusal lesions for 40 seconds failed to significantly reduce the numbers of viable bacteria in infected dentin beneath the demineralized enamel.3
For the treatment of pit-and-fissure caries, the use of minimally invasive restorations and sealants is a clinically proven treatment technique. Ozone is currently not the answer. For the treatment of root caries alone, ozone therapy may be an adjunctive treatment that is worth looking at, but again, this treatment is not the complete answer in the treatment of root caries. Patient compliance with at-home remineralization therapies and future restorative interventions will still be necessary. There should be concern that ozone therapy may be used to “sterilize” cavity preparations without any clinical evidence that there will be an improvement in outcome from that of a well-sealed restoration.
References1. McComb D. No reliable evidence that ozone gas stops or reversed tooth decay. Evid Based Dent. 2005;6(2):34.
2. Rickard GD, Richardson R, Johnson T, et al. Ozone therapy for the treatment of dental caries. Cochrane Database Syst Rev. 2004(3):CD004153.
3. Baysan A, Beighton D. Assesssment of the ozone-mediated killing of bacteria in infected dentine associated with non-cavitated occlusal carious lesions. Caries Res. 2007;41(5):337-341.
Howard E. Strassler, DMD
Professor and Director of Operative Dentistry
Department of Endodontics, Prosthodontics and Operative Dentistry
University of Maryland Dental School, Baltimore, Maryland