Pregnant women were eligible to participate if they were in the first or second trimester, had at least mild dental pain as identified by a score of at least 5 mm on a Visual Analogue Scale (VAS) 100-mm-long [28], and with at least one carious lesion involving dentine clinically classified as a shallow or medium cavity. This cavity should be accessible to hand instruments (International Caries Detection and Assessment System (ICDAS) score = 5 or 6) [29]). Pregnant women with acute pulpitis, swelling or fistula as well as uncooperative patients, those having severe gingivitis (Gingival Index (GI) score = 3 [30]), those who are unable to read and/or write and those who refused to participate were excluded from the study.

Sample size was based on assuming a 5% alpha error, 20% beta error and reported percentage of patients with pain after using chemo-mechanical caries removal = 68% and 35% after ART [31]. The minimum required number of patients was estimated to be 33 per group [32]. This was increased to 40 to make up for loss to follow up. Pain and effect of the two treatment modalities was assumed to be affected by the extent of dental caries and; hence, stratified by the number of surfaces affected by dental caries into single and multi-surface lesions, creating two strata per group. The number of participants, therefore, per group was 80 with a total of 160 participants.

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