Effectiveness of Biodentine in Apexification of Immature Teeth: A Prospective Clinical Study

Introduction: Apical periodontitis results from microbial infection in the root canal system, prompting endodontic treatment to eliminate infection and prevent reinfection. Apexification addresses the cessation of root development in teeth with incomplete formation and pulpal necrosis, using materials such as Calcium Hydroxide (CH), Mineral Trioxide Aggregate (MTA), or Biodentine. By utilising Biodentine’s unique properties in a single-step apexification approach, this study seeks to provide evidence-based insights into its efficacy in reducing lesion size, promoting apical healing, and minimising procedural complexities. The findings will contribute to the growing body of literature supporting Biodentine as a viable alternative to traditional apexification techniques, potentially influencing future clinical protocols for managing immature teeth with open apices. Aim: To assess the effectiveness of Biodentine as a material in the apexification of immature teeth with periapical lesions. Materials and Methods: This prospective clinical study, approved by the Institutional Ethics Committee, was conducted at Department of Conservative Dentistry and Endodontics, Dr. R. Ahmed Dental College and Hospital, Kolkata, West Bengal, India, from March 2014 to February 2016. Forty healthy patients aged 14 to 50 years, with traumatised maxillary incisors exhibiting incomplete root development and open apices, were included in the study. The inclusion criteria specified teeth with chronic apical periodontitis or wide apical foramina. Preoperative evaluations included clinical assessments and radiographic examinations. The apexification procedures involved thorough canal preparation, disinfection, application of Biodentine, and subsequent obturation with gutta percha. Follow-ups were scheduled at 1, 3, 6, 9, 12, and 18 months. Friedman’s ANOVA with post-hoc Dunn’s test and the Binomial test were employed for statistical analysis at an alpha level of 5%. Results: Initially, although 40 patients were recruited, only 33 completed all follow-ups and were included in the final analysis. After accounting for dropouts, the median age of participants was 29 years (IQR: 19-39.5), with an age range of 14-47 years. The study included 19 males (57.6%) and 14 females (42.4%), with no significant gender association across groups (p=0.49). The median lesion size (IQR) decreased progressively: preoperative 21 mm2 (10-40), 18 mm2 (9-33.5) at one month, 15 mm2 (7-22) at three months, 7 mm2 (3.5-16) at six months, 4 mm2 (0.5-12) at nine months, 1 mm2 (0-7) at 12 months, and 0 mm2 (0-2.5) at 18 months, reflecting reductions of 13.44-88.91%. Younger patients (<20 years) showed greater lesion reduction at 18 months compared to older patients (33 mm2 vs. 14 mm2 , p=0.03), with no gender differences (p=0.86). At the 18-month follow-up, pain or discomfort was absent in 29 (87.9%) patients (p<0.001). Tenderness on palpation was absent in 30 (90.9%) (p<0.001), and tenderness on percussion was absent in 29 (87.9%) (p<0.001). An abscess or sinus was not observed in any patient (33 [100%]). Clinical and radiographic success was achieved in 29 (87.9%) cases, while 4 (12.1%) cases were classified as failures (p<0.001). Conclusion: Apexification using Biodentine shows promising outcomes; however, its efficacy relative to conventional methods could not be definitively established. Comparative studies with traditional materials, larger cohorts, and extended follow-ups are needed to validate its potential as an alternative for managing immature teeth with open apices.