Clinical evaluation of efficacy and safety of a new method for chemo-mechanical removal of caries. A multi-centre study.

The aim of the study was to evaluate the clinical efficacy and safety of a new method (Carisolvtrade mark) for chemo-mechanical removal of caries. At four centres, 137 consecutive patients (64 females and 73 males aged 3-85 years, mean 35) entered a prospective, controlled, randomised open study. One primary caries lesion with distinct dentine involvement was selected per patient. A total of 116 lesions in permanent and 21 in deciduous teeth were selected. Caries was removed with traditional drilling or the new method. Gel was applied onto the carious dentine and the softened caries gently removed with specially designed hand instruments. New gel was applied and the procedure was repeated until no more debris could be removed and the surface was hard as judged by clinical criteria (probing and visual inspection). An independent examiner judged the cavity being caries-free or not, using clinical criteria. One hundred and thirteen patients were randomised for gel treatment and 24 for drilling. Three patients selected for drilling did not complete the treatment. Total caries removal was achieved in 106 cases with gel and in 19 with drilling. The reasons for incomplete caries removal were step-by-step excavation in 5 cases, unsuccessful caries removal in 1 case for each treatment, while 2 cases refused inspection. Mean (+/- SD) time for caries removal was 10.4 (+/-6.1) min with the gel method and 4.4 (+/-2.2) min with drilling. Mean volume of gel used was 0.4 (+/-0.2) ml. Eighty-two of 107 patients perceived that the new method caused less discomfort compared to drilling. Dentine caries was effectively removed using the Carisolv method without any adverse reactions.