Trial reportBMC oral health2025
Clinical and radiographic outcomes of pulpectomy in primary teeth using two rotary file systems compared with manual files: a cost-effectiveness analysis.
Trial report in BMC oral health, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. It is linked to trial NCT04279041 (In-vitro and In-vivo Comparative Evaluation of Rotary Fanta and Zunba Files in Root Canal Preparation of Infected Primary Molars), which is not on this map. Not yet cited in PubMed.
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The trial behind it
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In-vitro and In-vivo Comparative Evaluation of Rotary Fanta and Zunba Files in Root Canal Preparation of Infected Primary Molars
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Authors and funding
4 authors.
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Abstract
objectivesThis study aimed to evaluate the clinical and radiographic success of endodontic treatment in primary molars, in addition to the evaluation of the working time (WT) and cost-effectiveness Ratio (CER), and Incremental Cost-Effectiveness Ratio (ICER) of the Fanta AF Baby and Zuanba file systems, compared to manual K-files. MATERIALS AND
methodsOne hundred and sixty-two-second primary molars were randomly assigned into three groups, according to the type of the instrumentation file system. A pulpectomy procedure was performed, and the average WT was recorded for each group. Clinical assessments were made at 3-, 6-, and 12-month follow-ups, while radiographic assessments were performed at 6- and 12-month follow-ups. The direct medical cost for one molar in each group was calculated, and the (CER) was determined for each group. ICER was calculated for each group, based on the average WT and radiographic success at the 12-month mark as clinical effectiveness parameters.
resultsThe average WT in the manual K-file group was 14.65 (± 1.85) minutes, while the Fanta AF baby file system and Zuanba file system group had an average WT of 10.52 (± 1.13) minutes, and 9.46 (± 1.12) minutes, respectively. By the end of the follow-up period, all groups exhibited the same clinical success rate of 96.7%, with no statistically significant difference (p > 0.05). For the radiographic success, the K-file group displayed a higher frequency of failures (11.1%), followed by the Fanta AF baby file system group (7.4%). The Zuanba file system group had the fewest failures, reporting only two cases (3.7%). Regarding ICER, the Fanta AF Baby files system was found to incur an additional cost of 50.63 EGP for reducing one minute of working time, and 52 EGP for achieving one extra successfully treated second primary molar compared to the K-files system. While the Zuanba file system costs an additional 10.98 EGP for reducing one minute of WT, and an extra 28.5 EGP for getting an extra second primary molar successfully treated compared to the K-files.
conclusionBoth assessed rotary file systems showed shorter average WT, higher radiographic success, and CER compared to the manual k file. CLINICAL RELEVANCE: This study aids the pediatric dentist in the choice of the most effective, both clinically and economically, rotary filling system for endodontic treatment of primary molars.
trial registrationThe clinical trial was registered at clinical trial.gov identifier NCT04279041, on 2020-02-18.
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