NCT05305417

Cell-free Autologous Regenerative Endodontics Treatment for Teeth With Periapical Lesions (CARETT)

Cell-free Autologous Regenerative Endodontics Treatment for Permanent Mature Teeth With Pulp Necrosis and Periapical Lesions: a Randomized, Controlled Phase III Clinical Trial (CARETT)

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 228 (estimated)
• Sponsor: Universidad de Valparaiso · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

Conventional endodontic treatment has been the treatment of choice for the management of signs and symptoms of mature permanent teeth with pulpal necrosis and periapical lesion with predictable and favorable results. However, treatment outcomes have not shown improvement or innovation in decades. The main objective of this study is to evaluate the clinical effectiveness of a regenerative endodontic procedure (cell-free and autologous protocol) versus conventional endodontics in the resolution of signs and symptoms of periapical lesion and pulp vitality-sensitivity in mature permanent teeth with a diagnosis of pulpal necrosis and periapical lesion.

Detailed description

Conventional endodontic treatment has been an effective treatment option for decades to treat signs and symptoms in mature permanent teeth with a diagnosis of apical lesion due to pulpal necrosis, allowing the teeth to be kept in the mouth free of signs/symptoms but devitalized. The clinical effectiveness of conventional treatment in this type of case is ≥80%, with some variations according to different studies. Despite advances and modifications in treatment protocols, this therapy has not shown improvements or innovations in its results in recent decades. The Regenerative Endodontics alternative is postulated as a biologically based endodontic treatment option that allows to resolve the signs and symptoms along with dental revitalization through the regeneration of the pulpal connective tissue, generating a substantive possibility of innovation and improvements to the therapy of conventional endodontics. Various regenerative endodontic protocols have been proposed to achieve pulp tissue regeneration, from sophisticated techniques that involve cell transplantation, provision of scaffolds and/or signaling molecules, or simpler protocols that appeal to the autologous capacity of the organism to regenerate tissue. lost. The main objective of this study is to evaluate the clinical effectiveness of a cell-free regenerative endodontic procedure with the contribution of an autologous scaffold (L-PRF) versus conventional endodontics in the recovery of signs of periapical lesion and pulp vitality-sensitivity in mature permanent teeth with diagnosis of pulpal necrosis and periapical lesion.

Conditions

• Periapical Diseases
• Pulp Necroses

Interventions

Type	Name	Description
PROCEDURE	Autologous Regenerative Endodontic Treatment	The intervention consist in achieve an access to the teeth root canal system, do a chemico-mechanical preparation each root canal for to be obturated with an autologous biological scaffold and bioactive biomaterials to maintain teeth free of signs/symptoms caused by pulp necroses and periapical lesions
PROCEDURE	Conventional Root Canal Treatment	The intervention consist in achieve an access to the teeth root canal system, do a chemico-mechanical preparation each root canal for to be obturated with an inert biomaterial to maintain teeth free of signs/symptoms caused by pulp necroses and periapical lesions

Timeline

• Start date: 2023-03-01
• Primary completion: 2024-03-01
• Completion: 2025-03-01
• First posted: 2022-03-31
• Last updated: 2022-03-31