Application of Three Types of Scaffolds in Pulp Regeneration for Permanent Mature Teeth with Periapical Lesions: A Randomized Controlled Trial

Objective: This study aimed to evaluate pulp regeneration by comparing the application of native chitosan-based scaffolds with enzymatically modified chitosan-based scaffolds in mature teeth with apical lesions, using clinical and radiographic assessments.
Methods: The eligibility criteria for this study were participants aged between 15–45 years, free from systemic diseases and with necrotic mature single-rooted teeth with periapical lesions. The teeth were equally and randomly allocated into three groups (1: 1: 1 allocation): Group A received treatment with a Blood Clot (BC) scaffold; Group B with a combination of Native Chitosan and Blood Clot (NCS+BC) scaffold; and Group C with Enzymatically-Modified Chitosan and Blood Clot (EMCS+BC) scaffold. Clinical procedures were performed over two appointments. During the first appointment, canals underwent standardized mechanical and chemical preparation, followed by a modified triple antibiotic paste application, then sealed with glass ionomer cement. After three weeks, the antibiotic paste was removed. Subsequently, the regenerative procedure was conducted based on the group assignment. Participants were monitored at one, three, six-, and twelve months post-treatment to evaluate the treated teeth clinically and radiographically, focusing on the status of periapical lesions and tooth sensibility through cold testing. Statistical analysis included the Kruskal-Wallis and Mann-Whitney U tests to determine significant differences in healing degrees among the three groups over time. Additionally, the Chi-square test was used to assess significant differences in tooth sensibility frequencies during the cold test across the groups.
Results: Thirty teeth from twenty-four participants were included. There were no significant differences in the frequencies of healing degrees among the three studied groups (BC, NCS+BC, EMCS+BC) after one, three, and twelve months. The degree of healing after six months in the EMCS+BC group was higher than in other groups, and there were no statistically significant differences in the frequencies of healing degrees after six months between the NCS+BC group and BC group. The frequencies of tooth sensibility in the cold test among the three studied groups (BC, NCS+BC, EMCS+BC) were significantly different after six and twelve months. The tooth sensibility in the BC group was smaller than that of both the NCS+BC group and EMCS+BC group, and there were no statistically significant differences in the frequencies of tooth sensibility between the NCS+BC group and EMCS+BC group.
Conclusion: The application of the EMCS+BC scaffold demonstrates superior outcomes in pulp regeneration after six months, with a higher degree of healing observed compared to the NCS+BC and BC groups. There were no statistically significant differences at one month, three months, and twelve months. Additionally, tooth sensitivity was more pronounced in the EMCS+BC and NCS+BC groups. (EEJ-2024- 08-132)