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NCT Number: NCT07291531

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

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Key information

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The Second Affiliated Hospital of Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310002, China

Location contact

Jiajia Xia

CONTACT

[email protected]

+8618857862012

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

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).

Other names: 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).

Other names: 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.

Primary outcomes

  1. Success Rate

    Time frame: 1 year and 5 years postoperatively

    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.

  2. Survival Rate

    Time frame: 1 year and 5 years postoperatively

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

  3. Incidence of Inflammatory Root Resorption

    Time frame: 1 year and 5 years postoperatively

    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.

Secondary outcomes

  1. Pulp Revascularization/Survival (RER Group)

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

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

  2. Radiographic Periodontal Ligament Healing

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

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

Study contacts

Contact information is provided by the study sponsor or research team.

Jiajia XIa

CONTACT

[email protected]

+8618857862012

Sponsors and collaborators

Lead sponsor

Second Affiliated Hospital, School of Medicine, Zhejiang University

Other

Registry information

Official study title

Optimizing Pulp Management Strategies for Autotransplantation of Fully Developed Third Molars: A Three-Arm Randomized Controlled Trial

Acronym: OPuM-ATM3

Important dates

Study start
2026
Primary completion
2031
Study completion
2032
First posted
Dec 18, 2025
Registry last updated
Dec 18, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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