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

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-40
SponsorSecond Affiliated Hospital, School of Medicine, Zhejiang University

About this trial

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.

Eligibility criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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.

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Postoperative Root Canal Therapy

    Procedure/Surgery

    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

    Procedure/Surgery

    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

    Procedure/Surgery

    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.

Treatment groups

360 Participants
are divided into 3 treatment groups
Group A: Postoperative Root Canal Therapy (PRCT)Active comparator 1 intervention
Group B: Apical Surgery with Retrograde Filling (AS)Experimental treatment 1 intervention
Group C: Root-End Resection Only (RER)Experimental treatment 1 intervention

Trial outcomes

Primary outcomes

1

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.

Time frame
1 year and 5 years postoperatively
2

Survival Rate

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

Time frame
1 year and 5 years postoperatively
3

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.

Time frame
1 year and 5 years postoperatively

Secondary outcomes

1

Pulp Revascularization/Survival (RER Group)

Assessment of pulp vitality via clinical tests (electric pulp test, cold test) in the RER group.

Time frame
Postoperative 3, 6, 12 months, and then annually up to 5 years
2

Radiographic Periodontal Ligament Healing

Evaluation of the uniformity, continuity, and width of the periodontal ligament space on periapical radiographs/CBCT at specified intervals, and detection of ankylosis.

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

Other outcomes

Sponsors and contacts

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