Optimizing Pulp Management in Autotransplantation of Mature Third Molars: A Randomized Controlled Trial (OPuM-ATM3)

Zhejiang University

Status: Not yet enrolling

Conditions: Tooth, Impacted; Dental Pulp Diseases; Tooth Avulsion

Treatments: Procedure: Intraoperative Root-End Resection; Procedure: Intraoperative Apical Surgery with Retrograde Filling; Procedure: Postoperative Root Canal Therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT07291531

2025-1392

Details and patient eligibility

About

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.

Enrollment: 360 estimated patients

Sex: All

Ages: 18 to 40 years old

Volunteers: Accepts Healthy Volunteers

Inclusion criteria

1. Aged 18-40 years.
2. Requires extraction of a non-restorable first or second molar AND possesses a fully developed, morphologically healthy ipsilateral third molar as a donor tooth.
3. Willing and able to provide written informed consent.

Exclusion criteria

1. Presence of acute infection or insufficient bone volume at the recipient site.

2. Donor tooth exhibits caries, periapical pathology, or periodontal disease.

3. Uncontrolled systemic disease (e.g., diabetes, immunosuppression), pregnancy, or lactation.

   Smoking habit of >10 cigarettes per day.

4. Inability or unwillingness to comply with the long-term follow-up schedule.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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360 participants in 3 patient groups

Postoperative Root Canal Therapy (PRCT)

Active Comparator group

Description:

Participants in this group will receive conventional autotransplantation of a fully developed third molar. No additional apical procedure is performed on the donor tooth during surgery. Standard non-surgical root canal therapy will be initiated and completed within 2-4 weeks after the transplantation procedure.

Treatment:

Procedure: Postoperative Root Canal Therapy

Apical Surgery with Retrograde Filling (AS)

Experimental group

Description:

Participants in this group will receive autotransplantation of a fully developed third molar with intraoperative apical surgery. During surgery (ex vivo), the root apex (approximately 3mm) of the donor tooth is resected, followed by retrograde cavity preparation and obturation with a biocompatible material (e.g., MTA). Standard non-surgical root canal therapy will also be initiated and completed within 2-4 weeks postoperatively.

Treatment:

Procedure: Intraoperative Apical Surgery with Retrograde Filling

Root-End Resection Only (RER)

Experimental group

Description:

Participants in this group will receive autotransplantation of a fully developed third molar with intraoperative root-end resection only. During surgery (ex vivo), the root apex (approximately 3mm) is resected to enlarge the apical foramen, but no retrograde preparation or filling is performed. No prophylactic root canal therapy is planned postoperatively. Remedial root canal therapy will be provided only if signs/symptoms of pulp necrosis or apical periodontitis develop during follow-up.

Treatment:

Procedure: Intraoperative Root-End Resection