The Second Affiliated Hospital of Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310002, China
NCT Number: NCT07291531
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.
Trial opening soon.
Get Notified18 year–40 year
All sexes
Interventional
Not applicable
Hangzhou, Zhejiang, 310002, China
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Smoking habit of >10 cigarettes per day.
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
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
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.
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.
Time frame: 1 year and 5 years postoperatively
The proportion of transplanted teeth remaining in the oral cavity and functional.
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.
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.
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.
Contact information is provided by the study sponsor or research team.
Second Affiliated Hospital, School of Medicine, Zhejiang University
Other
Optimizing Pulp Management Strategies for Autotransplantation of Fully Developed Third Molars: A Three-Arm Randomized Controlled Trial
Acronym: OPuM-ATM3
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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