Tooth AvulsionOPuM-ATM3NCT07291531
Optimizing Pulp Management in Autotransplantation of Mature Third Molars: A Randomized Controlled Trial
A study testing Postoperative Root Canal Therapy, Intraoperative Apical Surgery with Retrograde Filling and Intraoperative Root-End Resection in people with Tooth Avulsion and Dental Pulp Diseases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 yearsHealthy volunteers can take part
- Conditions the study is for
- Tooth Avulsion, Dental Pulp Diseases, Tooth, Impacted
- What is being tested?
- Postoperative Root Canal Therapy, Intraoperative Apical Surgery with Retrograde Filling and Intraoperative Root-End Resection
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 360 participants
- Where
- 1 siteChina
- Study dates
- Jan 2026to Jun 2032
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site
The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310002
Jiajia Xia, +8618857862012, jackey-xia@zju.edu.cn
About this study
Official title: Optimizing Pulp Management Strategies for Autotransplantation of Fully Developed Third Molars: A Three-Arm 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:
Read more
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.
- Conditions
- Tooth Avulsion, Dental Pulp Diseases, Tooth, Impacted
- Being tested
- Postoperative Root Canal Therapy, Intraoperative Apical Surgery with Retrograde Filling, Intraoperative Root-End Resection
- Keywords
- Autotransplantation, Third molar, Root canal therapy, Apical surgery, Root-end resection, mature tooth
- Medical subject headings
- Tooth Avulsion, Dental Pulp Diseases, Tooth, Impacted
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Postoperative Root Canal TherapyProcedure or surgery
Also called PRCT
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 FillingProcedure or surgery
Also called AS
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 ResectionProcedure or 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.
| Study group | Role | What they receive |
|---|---|---|
| Postoperative Root Canal Therapy (PRCT) | Active comparator | 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. Receives: Procedure: Postoperative Root Canal Therapy |
| Apical Surgery with Retrograde Filling (AS) | Experimental | 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. Receives: Procedure: Intraoperative Apical Surgery with Retrograde Filling |
| Root-End Resection Only (RER) | Experimental | 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. Receives: Procedure: Intraoperative Root-End Resection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year and 5 years postoperatively
Survival Rate
The proportion of transplanted teeth remaining in the oral cavity and functional.
Measured: 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.
Measured: 1 year and 5 years postoperatively
Secondary outcomes (2)
Pulp Revascularization/Survival (RER Group)
Assessment of pulp vitality via clinical tests (electric pulp test, cold test) in the RER group.
Measured: 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.
Measured: Postoperative 3, 6, 12 months, and then annually up to 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Dec 2025
- Study startJan 2026 (estimated)
- Primary completionJun 2031 (estimated)
- Study completionJun 2032 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Tooth AvulsionStudies of the same condition, open and under way.
- More trials run by Second Affiliated Hospital, Zhejiang University, School of MedicineThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 360 participants (estimated)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07291531
- Sponsor's protocol ID
- 2025-1392
- Acronym
- OPuM-ATM3
- Status last verified
- Dec 2025
- First submitted
- 7 Dec 2025
- Last updated
- 18 Dec 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: De-identified IPD will be shared with researchers upon reasonable request and approval of a proposal.
Study at a glance
From the registry record, last updated by the sponsor on 18 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Optimizing Pulp Management Strategies for Autotransplantation of Fully Developed Third Molars: A Three-Arm Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT07291531
- Acronym / sponsor ID
- OPuM-ATM3 / 2025-1392
- Conditions
- Tooth Avulsion, Dental Pulp Diseases, Tooth, Impacted
- Keywords
- Autotransplantation, Third molar, Root canal therapy, Apical surgery, Root-end resection, mature tooth
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 360 participants (estimated)
- Lead sponsor
- Second Affiliated Hospital, Zhejiang University, School of MedicineUniversity, hospital or other
- Study start
- Jan 2026 (estimated)
- Primary completion
- Jun 2031 (estimated)
- Study completion
- Jun 2032 (estimated)
- First posted
- 18 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Postoperative Root Canal Therapy (PRCT) | Active comparator | Procedure: Postoperative Root Canal TherapyParticipants 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. |
| Apical Surgery with Retrograde Filling (AS) | Experimental | Procedure: Intraoperative Apical Surgery with Retrograde FillingParticipants 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. |
| Root-End Resection Only (RER) | Experimental | Procedure: Intraoperative Root-End ResectionParticipants 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. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (5 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Postoperative Root Canal TherapyAlso: PRCTThis 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). | Procedure or surgery | Postoperative Root Canal Therapy (PRCT) |
| Intraoperative Apical Surgery with Retrograde FillingAlso: ASThis 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). | Procedure or surgery | Apical Surgery with Retrograde Filling (AS) |
| Intraoperative Root-End ResectionThis 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. | Procedure or surgery | Root-End Resection Only (RER) |
Primary outcome
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.
Survival Rate
Time frame: 1 year and 5 years postoperatively
The proportion of transplanted teeth remaining in the oral cavity and functional.
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.
2 secondary outcomes
Pulp Revascularization/Survival (RER Group)
Time frame: Postoperative 3, 6, 12 months, and then annually up to 5 years
Radiographic Periodontal Ligament Healing
Time frame: Postoperative 3, 6, 12 months, and then annually up to 5 years
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Dec 2025.
- Individual participant dataSharing planned: Yes. De-identified IPD will be shared with researchers upon reasonable request and approval of a proposal.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Postoperative Root Canal Therapy, Intraoperative Apical Surgery with Retrograde Filling and Intraoperative Root-End Resection in people with Tooth Avulsion and Dental Pulp Diseases, run by Second Affiliated Hospital, Zhejiang University, School of Medicine at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 18 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Jiajia XIa (+8618857862012, jackey-xiaj@zju.edu.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Success Rate (time frame: 1 year and 5 years postoperatively). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 18 Dec 2025.