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

NCT07291531 | Not Yet Recruiting DMC

• 1 other identifier: 2025-1392
• Study Type: interventional
• Target: 360
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Autotransplantation; Third molar; Root canal therapy; Apical surgery; Root-end resection; mature tooth

Outcome Measures

Primary Outcomes (3)

• Success Rate

  Comprehensive success defined as the transplanted tooth being present, functional, asymptomatic (no pain on percussion, no sinus tract), with healthy gingiva, and no radiographic evidence of progressive inflammatory root resorption or periapical radiolucency.

  1 year and 5 years postoperatively

• Survival Rate

  The proportion of transplanted teeth remaining in the oral cavity and functional.

  1 year and 5 years postoperatively

• Incidence of Inflammatory Root Resorption

  The proportion of transplanted teeth exhibiting radiographic signs of inflammatory root resorption (periapical radiolucency adjacent to the root surface with loss of lamina dura) on periapical radiograph or CBCT.

  1 year and 5 years postoperatively

Secondary Outcomes (2)

• Pulp Revascularization/Survival (RER Group)

  Postoperative 3, 6, 12 months, and then annually up to 5 years

• Radiographic Periodontal Ligament Healing

  Postoperative 3, 6, 12 months, and then annually up to 5 years

Study Arms (3)

Postoperative Root Canal Therapy (PRCT)

ACTIVE COMPARATOR

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.

Procedure: Postoperative Root Canal Therapy

Apical Surgery with Retrograde Filling (AS)

EXPERIMENTAL

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.

Procedure: Intraoperative Apical Surgery with Retrograde Filling

Root-End Resection Only (RER)

EXPERIMENTAL

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.

Procedure: Intraoperative Root-End Resection

Interventions

Postoperative Root Canal Therapy PROCEDURE

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).

Also known as: PRCT

Postoperative Root Canal Therapy (PRCT)

Intraoperative Apical Surgery with Retrograde Filling PROCEDURE

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).

Also known as: AS

Apical Surgery with Retrograde Filling (AS)

Intraoperative Root-End Resection PROCEDURE

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.

Root-End Resection Only (RER)

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Second Affiliated Hospital, School of Medicine, Zhejiang University: lead

Study Sites (1)

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310002, China

Location

MeSH Terms

Conditions

Tooth Avulsion; Dental Pulp Diseases; Tooth, Impacted

Condition Hierarchy (Ancestors)

Tooth Injuries; Tooth Diseases; Stomatognathic Diseases; Wounds and Injuries

Central Study Contacts

Jiajia XIa

CONTACT

+8618857862012; jackey-xiaj@zju.edu.cn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: December 18, 2025
• Study Start: January 1, 2026
• Primary Completion (Estimated): June 1, 2031
• Study Completion (Estimated): June 1, 2032
• Last Updated: December 18, 2025

Record last verified: 2025-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: The IPD and supporting documents will become available 12 months after the publication of the primary results\*\* (the manuscript reporting the primary outcomes). They will remain accessible for at least 5 years.
• Access Criteria: Access will be granted to researchers who provide a methodologically sound proposal, approved by an independent review committee ("data access committee"). Proposals should be directed to the corresponding author. Requestors will need to sign a data access agreement specifying that data will be used only for the approved purpose, not to attempt to identify participants, and will be destroyed after use.

Locations

CN (1)