A comparative evaluation of the obturation quality in primary mandibular molars using a novel obturating material versus Endoflas: a double blinded randomized clinical trial

Abstract

Pulpectomy in primary teeth requires thorough debridement and obturation with a material that is biocompatible, resorbable, and aligned with the physiological root resorption process. While zinc oxide eugenol and Endoflas are commonly used, they present limitations such as inconsistent resorption, limited antimicrobial action, and potential tissue irritation. A novel obturating material comprising Zinc oxide, Calcium hydroxide, and Metronidazole was developed to overcome these challenges. Objective: To compare the obturation quality in primary mandibular molars using a novel obturating material versus Endoflas. Material and Methods: A double-blinded, randomized clinical trial was conducted in 20 children aged 3-7 years, indicated for pulpectomy. Group I received the novel obturating material, and Group II received Endoflas. All procedures followed standardized protocols, and obturation quality was assessed radiographically using the Coll and Sadrian criteria by two calibrated evaluators. Statistical analysis included the Chi-square test and Mann-Whitney U test (significance level set at p < 0.05). Results: Both groups were demographically comparable. Optimal filling was observed in 40% of Group I and 30% of Group II. Overfilling and underfilling scores were similar between groups. No statistically significant differences were observed in filling quality (U = 49.500, p = 0.96), age (p = 0.61), or treated tooth distribution (p = 0.83). Conclusion: The novel obturating material showed comparable clinical performance to Endoflas in terms of radiographic obturation quality. Its formulation may offer improved antimicrobial benefits and could be considered as an alternative material in primary tooth pulpectomy.

KEYWORDS

Endoflas; Metronidazole; Obturation; Primary teeth; Pulpectomy.