Optimizing Pulp Management in Autotransplantation of Mature Third Molars: A Randomized Controlled Trial
NCT ID: NCT07291531
Last Updated: 2025-12-18
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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NOT_YET_RECRUITING
NA
360 participants
INTERVENTIONAL
2026-01-31
2032-06-30
Brief Summary
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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.
Detailed Description
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Conditions
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Keywords
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Postoperative Root Canal Therapy (PRCT)
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.
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).
Apical Surgery with Retrograde Filling (AS)
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.
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).
Root-End Resection Only (RER)
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.
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.
Interventions
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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).
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).
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.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
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
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.
18 Years
40 Years
ALL
Yes
Sponsors
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Second Affiliated Hospital, School of Medicine, Zhejiang University
OTHER
Responsible Party
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Locations
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The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, China
Countries
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Central Contacts
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Facility Contacts
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Jiajia Xia
Role: primary
Other Identifiers
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2025-1392
Identifier Type: -
Identifier Source: org_study_id