Pulp Transplantation in Necrotic Mature Teeth With Periapical Radiolucency
NCT ID: NCT07258888
Last Updated: 2025-12-09
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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COMPLETED
NA
21 participants
INTERVENTIONAL
2023-11-05
2025-09-05
Brief Summary
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Twenty-one patients with single-rooted teeth presenting with periapical lesions are randomly allocated into three groups (n = 7 per group): Group 1 receives autologous pulp transplantation, Group 2 receives pulp transplantation combined with CGF, and Group 3 receives conventional root canal treatment. Donor pulp tissue is obtained from the patient's own non-carious third molars. Clinical and radiographic follow-up is planned at 3, 6, and 12 months, including electrical pulp testing, periapical radiographs, and cone-beam computed tomography (CBCT).
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Detailed Description
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Participants are adults presenting with single-rooted teeth diagnosed with pulp necrosis and periapical pathology. Following randomization, the allocated intervention is performed under standardized clinical protocols. Donor pulp tissue is harvested atraumatically from non-carious third molars of the same patient. Outcome assessments include vitality testing and radiographic evaluations at predetermined follow-up intervals. The study aims to provide foundational clinical evidence regarding the feasibility, safety, and regenerative potential of autologous pulp transplantation techniques to inform future clinical applications.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
SINGLE
Study Groups
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Conventional Root Canal Therapy
Patients undergo standard root canal preparation and obturation with gutta-percha and sealer using lateral condensation, followed by restoration.
Conventional root canal therapy
Standard root canal instrumentation, irrigation, obturation with gutta-percha and sealer, and restoration.
Autologous dental pulp transplantation
Harvest of autologous third-molar pulp; canal disinfection; transplantation; MTA coronal seal; restoration.
Autologous dental pulp transplantation
Harvest of autologous pulp tissue from third molar, canal disinfection, placement into recipient tooth, MTA sealing, composite restoration.
Pulp transplantation with CGF
Same as pulp transplantation with the addition of autologous concentrated growth factor (CGF) placed over the transplanted pulp prior to MTA seal.
Pulp transplantation with CGF
Same as above, but CGF membrane placed over transplanted pulp before MTA sealing.
Interventions
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Conventional root canal therapy
Standard root canal instrumentation, irrigation, obturation with gutta-percha and sealer, and restoration.
Autologous dental pulp transplantation
Harvest of autologous pulp tissue from third molar, canal disinfection, placement into recipient tooth, MTA sealing, composite restoration.
Pulp transplantation with CGF
Same as above, but CGF membrane placed over transplanted pulp before MTA sealing.
Eligibility Criteria
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Inclusion Criteria
* Presence of single-rooted permanent teeth diagnosed with:
* Pulp necrosis or
* Irreversible pulpitis with radiographic periapical lesions
* Availability of a caries-free, periodontally healthy third molar suitable for donor pulp harvesting
Good general health, with no systemic diseases
-Ability to understand the study procedures and provide written informed consent
Exclusion Criteria
* Systemic diseases or medical conditions that may affect wound healing (e.g., diabetes, immunosuppression)
* Lack of a suitable donor third molar for pulp harvesting
* Advanced periodontal attachment loss or active periodontal disease
* Pregnancy or lactation
* Recent use of antibiotics or anti-inflammatory drugs (\<1 month)
* Inability or unwillingness to attend scheduled follow-ups
18 Years
40 Years
ALL
No
Sponsors
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Kahramanmaras Sutcu Imam University
OTHER
Responsible Party
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Aliye Kamalak
Assoc Prof
Principal Investigators
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Aliye Kamalak, Associate Professor Dr.
Role: PRINCIPAL_INVESTIGATOR
Kahramanmaraş Sütçü İmam University, Faculty of Dentistry, Department of Endodontics
Locations
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ahramanmaraş Sütçü İmam University, Faculty of Dentistry
Kahramanmaraş, onikişubat, Turkey (Türkiye)
Countries
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References
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Cehreli ZC, Unverdi GE, Ballikaya E. Deciduous Tooth Pulp Autotransplantation for the Regenerative Endodontic Treatment of Permanent Teeth With Pulp Necrosis: A Case Series. J Endod. 2022 May;48(5):669-674. doi: 10.1016/j.joen.2022.01.015. Epub 2022 Feb 1.
Yan H, De Deus G, Kristoffersen IM, Wiig E, Reseland JE, Johnsen GF, Silva EJNL, Haugen HJ. Regenerative Endodontics by Cell Homing: A Review of Recent Clinical trials. J Endod. 2023 Jan;49(1):4-17. doi: 10.1016/j.joen.2022.09.008. Epub 2022 Oct 18.
Kim U, Kim S, Choi SM, Kang MK, Chang I, Kim E. Regenerative Endodontic Procedures With Minced Pulp Tissue Graft in Mature Permanent Teeth: A Clinical Study. J Endod. 2025 Jan;51(1):43-53.e2. doi: 10.1016/j.joen.2024.10.004. Epub 2024 Oct 12.
Study Documents
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Document Type: Individual Participant Data Set
Data sharing will follow institutional policies and ethical guidelines to ensure participant confidentiality.
View DocumentRelated Links
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Official website of the Faculty of Dentistry, Kahramanmaraş Sütçü İmam University - the institution where the study was conducted.
Other Identifiers
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Project No: 2024/3-13D
Identifier Type: OTHER_GRANT
Identifier Source: secondary_id
KSU-PT-2024-11
Identifier Type: -
Identifier Source: org_study_id
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