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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
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT07291531
Acronym
OPuM-ATM3
Enrollment
360
Registered
2025-12-18
Start date
2026-01-31
Completion date
2032-06-30
Last updated
2025-12-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Dental Pulp Diseases, Tooth Avulsion, Tooth, Impacted

Keywords

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

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.

Interventions

PROCEDUREPostoperative 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).

PROCEDUREIntraoperative 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).

PROCEDUREIntraoperative 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.

Sponsors

Second Affiliated Hospital, School of Medicine, Zhejiang University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
Success Rate1 year and 5 years postoperativelyComprehensive 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.
Survival Rate1 year and 5 years postoperativelyThe proportion of transplanted teeth remaining in the oral cavity and functional.
Incidence of Inflammatory Root Resorption1 year and 5 years postoperativelyThe 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.

Secondary

MeasureTime frameDescription
Pulp Revascularization/Survival (RER Group)Postoperative 3, 6, 12 months, and then annually up to 5 yearsAssessment of pulp vitality via clinical tests (electric pulp test, cold test) in the RER group.
Radiographic Periodontal Ligament HealingPostoperative 3, 6, 12 months, and then annually up to 5 yearsEvaluation of the uniformity, continuity, and width of the periodontal ligament space on periapical radiographs/CBCT at specified intervals, and detection of ankylosis.

Countries

China

Contacts

Primary ContactJiajia XIa
jackey-xiaj@zju.edu.cn+8618857862012

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026