Optimizing Pulp Management in Autotransplantation of Mature Third Molars: A Randomized Controlled Trial
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Postoperative Root Canal Therapy, Intraoperative Apical Surgery with Retrograde Filling, Intraoperative Root-End Resection.
- Who it may be relevant to
- Registry conditions: Tooth Avulsion, Dental Pulp Diseases, Tooth, Impacted. Basic parameters: 18 years — 40 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Official title
Optimizing Pulp Management Strategies for Autotransplantation of Fully Developed Third Molars: A Three-Arm Randomized Controlled Trial
Overview
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.
Interventions
- 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 pr
Primary outcome measures
- Success Rate [Time frame: 1 year and 5 years postoperatively]
- Survival Rate [Time frame: 1 year and 5 years postoperatively]
- Incidence of Inflammatory Root Resorption [Time frame: 1 year and 5 years postoperatively]
Secondary outcome measures (2)
- Pulp Revascularization/Survival (RER Group) [Time frame: Postoperative 3, 6, 12 months, and then annually up to 5 years]
- Radiographic Periodontal Ligament Healing [Time frame: Postoperative 3, 6, 12 months, and then annually up to 5 years]
Eligibility criteria
Inclusion criteria
- Aged 18-40 years.
- Requires extraction of a non-restorable first or second molar AND possesses a fully developed, morphologically healthy ipsilateral third molar as a donor tooth.
- Willing and able to provide written informed consent.
Exclusion criteria
- Presence of acute infection or insufficient bone volume at the recipient site.
- Donor tooth exhibits caries, periapical pathology, or periodontal disease.
- Uncontrolled systemic disease (e.g., diabetes, immunosuppression), pregnancy, or lactation.
Smoking habit of >10 cigarettes per day.
- Inability or unwillingness to comply with the long-term follow-up schedule.
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: Yes
Study design
- Allocation
- Randomized
- Model
- Parallel assignment
- Masking
- Single blind
- Primary purpose
- Treatment
Study locations
China · 1 center
- The Second Affiliated Hospital of Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT07291531 · 2025-1392