NCT07291531

Optimizing Pulp Management in Autotransplantation of Mature Third Molars: A Randomized Controlled Trial

Optimizing Pulp Management Strategies for Autotransplantation of Fully Developed Third Molars: A Three-Arm Randomized Controlled Trial

• Status: Not Yet Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 360 (estimated)
• Sponsor: Second Affiliated Hospital, School of Medicine, Zhejiang University · Academic / Other
• Sex: All
• Age: 18 Years – 40 Years
• Healthy volunteers: Accepted

Summary

This study aims to find the best way to use your own healthy wisdom tooth to replace the bad tooth. After transplantation, how to manage the "tooth nerve" (dental pulp) inside the tooth is a key question. Currently, doctors have three different management strategies, but it is not clear which one is most beneficial for long-term success. This study will compare these three strategies: Performing standard root canal treatment (removing the tooth nerve) a few weeks after transplantation. Performing a special procedure to treat and fill the root tip during the transplant surgery, followed by root canal treatment later. Simply trimming the root tip during the transplant surgery, hoping to preserve the vitality of the tooth nerve and thereby avoid subsequent root canal treatment. If you agree to participate, you will be randomly assigned to one of these groups to receive treatment. Afterwards, we will need to schedule regular check-ups for you over a period of 5 years (including X-rays and examinations) to monitor the healing of the transplanted tooth, check for any problems, and assess the status of the tooth nerve. Your participation will help us identify the most effective and long-lasting treatment method, thereby benefiting future patients in similar situations.

Conditions

• Tooth Avulsion
• Dental Pulp Diseases
• Tooth, Impacted

Interventions

Type	Name	Description
PROCEDURE	Postoperative Root Canal Therapy	This intervention involves the standard non-surgical root canal treatment of the autotransplanted tooth. It is performed after the surgical transplantation procedure, typically initiated within 2-4 weeks postoperatively. The procedure includes pulp extirpation, biomechanical preparation, disinfection, and obturation of the root canal system using standard techniques and materials (e.g., gutta-percha and sealer).
PROCEDURE	Intraoperative Apical Surgery with Retrograde Filling	This surgical intervention is performed on the donor tooth during the transplantation procedure, while the tooth is outside the mouth (ex vivo). It consists of: 1) Resection of approximately 3mm of the root apex; 2) Preparation of a retrograde cavity at the resected apex; and 3) Obturation of this cavity with a biocompatible material, such as Mineral Trioxide Aggregate (MTA), to achieve a seal. This is followed by postoperative root canal therapy (as described in Intervention 1).
PROCEDURE	Intraoperative Root-End Resection	This surgical intervention is performed on the donor tooth during the transplantation procedure, while the tooth is outside the mouth (ex vivo). It involves the resection of approximately 3mm of the root apex only, with the aim of enlarging the apical foramen. Crucially, no retrograde preparation or filling is performed. Postoperatively, no prophylactic (preventive) root canal therapy is planned. The goal is to promote revascularization and survival of the pulp. Remedial root canal therapy is provided only if clinical or radiographic signs of pulp necrosis or apical periodontitis develop during follow-up.

Timeline

• Start date: 2026-01-01
• Primary completion: 2031-06-01
• Completion: 2032-06-01
• First posted: 2025-12-18
• Last updated: 2025-12-18

Locations

1 site across 1 country: China