Clinical reversal of root caries using ozone, double-blind, randomised, controlled 18-month trial.

OBJECTIVE To assess the effect of an ozone delivery system, combined with the daily use of a remineralising patient kit, on the clinical severity of non-cavitated leathery primary root carious lesions (PRCL's), in an older population group. DESIGN A total of 89 subjects, (age range 60-82, mean +/- SD, 70.8 +/- 6 years), each with two leathery PRCL's, were recruited. The two lesions in each subject were randomly assigned for treatment with ozone or air, in a double-blind design, in a general dental practice. Subjects were recalled at three, six, 12 and 18 months. Lesions were clinically recorded at each visit as soft, leathery or hard, scored with a validated root caries severity index. RESULTS There were no observed adverse events. After three months, in the ozone-treated group, 61 PRCL's (69%) had become hard and none had deteriorated, whilst in the control group, four PRCL's (4%) had become worse (p<0.01). At the six-month recall, in the ozone group, seven PRCL's (8%) remained leathery, the remaining 82 (92%) PRCL's had become hard, whilst in the control group, 10 PRCL's had become worse (11%) and one had become hard (p<0.01). At 12 and 18 months, 87 Subjects attended. In the ozone group at 12 months, two PRCL's remained leathery, compared to 85 (98%) that had hardened, whilst in the control group 21 (24%) of the PRCL's had progressed from leathery to soft, i.e. became worse, 65 PRCL's (75%) were still leathery, and one remained hard (p<0.01). At 18 months, 87 (100%) of ozone-treated PRCL's had arrested, whilst in the control group, 32 lesions (37%) of the PRCL's had worsened from leathery to soft (p<0.01), 54 (62%) PRCL's remained leathery and only one of the control PRCL's had reversed (p<0.01). CONCLUSIONS Leathery non-cavitated primary root caries can be arrested non-operatively with ozone and remineralising products. This treatment regime is an effective alternative to conventional "drilling and filling".