A CLINICAL TRIAL EVALUATING THE SAFETY AND EFFICACY OF NOVEL BIOMATERIALS FOR TREATING ENDO-PERIO LESIONS

Abstract

Objective: This clinical trial aimed to evaluate the safety and efficacy of novel biomaterials in the treatment of combined endodontic-periodontal (endo-perio) lesions. Endo-perio lesions, which involve both the dental pulp and periodontal tissues, present a complex challenge in clinical practice. Conventional treatments often yield variable results, prompting the need for advanced biomaterials that may offer enhanced healing and clinical outcomes.Methods: A double-blind, randomized controlled trial was conducted with 60 patients diagnosed with moderate to severe endo-perio lesions. Patients were randomly assigned to receive either the novel biomaterial (experimental group) or conventional treatment (control group) for lesion management. The novel biomaterial was applied during endodontic therapy and periodontal treatment, and its effects were evaluated over a 12-month period. Primary outcome measures included clinical parameters such as probing depth, clinical attachment level, and radiographic evidence of bone regeneration. Secondary outcomes included patient-reported outcomes (pain, function, and quality of life), adverse events, and healing time.Results: The experimental group demonstrated statistically significant improvements in clinical attachment levels, reduction in probing depth, and enhanced bone regeneration as compared to the control group. Furthermore, there were no significant differences in adverse events between the groups, suggesting the safety of the novel biomaterial. Patients in the experimental group also reported higher levels of satisfaction and improved functional outcomes. The overall healing time in the experimental group was notably shorter.Conclusion: The novel biomaterial showed superior efficacy and safety in treating endo-perio lesions compared to conventional treatments. It promoted better clinical and radiographic outcomes, along with favorable patient-reported results. This biomaterial may represent a promising alternative for the management of complex endo-perio lesions, offering faster healing and improved long-term success.