The aim of this randomized, controlled, three-arm parallel-group, double-blinded clinical trial was to evaluate the clinical, radiographic, and histopathological success of three different pulp-capping materials in one-stage indirect pulp treatment of primary teeth. The study included a total of 109 patients aged 5-9 years who had primary teeth with deep carious lesions with or symptoms of irreversible pulpitis. The teeth were divided into three groups according to the pulp-capping agents: (I) Calcium hydroxide (Ca\[OH\]2) (control group) (n=36), (II) bioactive tricalcium silicate (Biodentine) (n=37), and (III) resin-based tricalcium silicate (TheraCal LC) (n=36). All the teeth were evaluated clinically and radiographically at postoperative months 6, 12, 18, and 24. A total of 23 primary mandibular second molars that were in their regular exfoliation period (24-40 months) were extracted and fixed in 10% formaldehyde solution. The specimens were evaluated histologically to assess the integrity of the odontoblastic layer, tertiary dentin formation and the quality of the dentin formed, severity of pulpitis, and other pulpal changes.
Age range
5 Years – 9 Years
Sex
ALL
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Clinical success rate of indirect pulp treatment
Timeframe: Change of clinical success from Baseline at 6 month
Clinical success rate of indirect pulp treatment
Timeframe: Change of clinical success from baseline to 12 month
Clinical success rate of indirect pulp treatment
Timeframe: Change of clinical success from baseline to 18 month
Clinical success rate of indirect pulp treatment
Timeframe: Change of clinical success from baseline to 24 month
Radiographic success rate of indirect pulp treatment
Timeframe: Change of radiographic success from baseline to 6 month
Radiographic success rate of indirect pulp treatment
Timeframe: Change of radiographic success from baseline to 12 month
Radiographic success rate of indirect pulp treatment
Timeframe: Change of radiographic success from baseline to 18 month
Radiographic success rate of indirect pulp treatment
Timeframe: Change of radiographic success from baseline to 24 month