An interventional study of Postoperative Root Canal Therapy and Intraoperative Apical Surgery with Retrograde Filling in Tooth Avulsion, Dental Pulp Diseases and Tooth, Impacted, sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University. Not yet recruiting at 1 site in China. Open to participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2025-12-18.
Sponsored by Second Affiliated Hospital, School of Medicine, Zhejiang University · Not applicable, Interventional, and Treatment
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.
130 studies on the registry are indexed under Dental Pulp Diseases; 37 are open to participants now.
This study's planned enrollment of 360 is above the median of 52 across 108 interventional studies indexed under Dental Pulp Diseases.
Browse Dental Pulp Diseases studies →Second Affiliated Hospital, School of Medicine, Zhejiang University is the lead sponsor of 1,047 studies on the registry; 502 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Uncontrolled systemic disease (e.g., diabetes, ), pregnancy, or lactation.
Smoking habit of >10 cigarettes per day.
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Immunosuppression
A weakened immune system. It can come from an illness, such as HIV or some blood cancers, or from medicines that turn the immune system down, for example after an organ transplant or for an autoimmune disease; steroids at higher doses count.
Read whether the line is about a condition or about medicines, and which medicines and doses it means.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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
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
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
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
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
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.
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
Survival Rate
The proportion of transplanted teeth remaining in the oral cavity and functional.
Time frame: 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.
Time frame: 1 year and 5 years postoperatively
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
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
Plan to share: Yes — De-identified IPD will be shared with researchers upon reasonable request and approval of a proposal.
Supporting information: Study protocol, Statistical analysis plan, Informed consent form
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.
No publications or documents are linked to this record.
Start is estimated for Jan 2026; primary completion for Jun 2031, 65 months later.
Of 60 non-industry interventional studies with no phase under Dental Pulp Diseases, half reached primary completion within 18 months of starting (the median), counting those still running; a quarter within 9 and three quarters within 34. This study's planned 65 months is above that.
Counting every sponsor, half of 60 studies reached it within 18 months; a quarter within 9 and three quarters within 34.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Dec 2025. You cannot join it, but the record below documents what was studied.
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Second Affiliated Hospital, School of Medicine, Zhejiang University →