Pulp Transplantation in Necrotic Mature Teeth With Periapical Radiolucency
TRANSP
2 other identifiers
interventional
21
1 country
1
Brief Summary
This randomized clinical trial aims to compare autologous dental pulp transplantation alone or combined with concentrated growth factor (CGF) with conventional root canal treatment in necrotic mature teeth with periapical radiolucency. The primary objective is to evaluate whether autologous pulp transplantation can facilitate the return of vitality in necrotic teeth. A secondary objective is to assess whether the addition of CGF provides any further clinical benefit. 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).
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Nov 2023
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 5, 2023
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 5, 2023
CompletedStudy Completion
Last participant's last visit for all outcomes
September 5, 2025
CompletedFirst Submitted
Initial submission to the registry
November 20, 2025
CompletedFirst Posted
Study publicly available on registry
December 2, 2025
CompletedDecember 9, 2025
December 1, 2025
Same day
November 20, 2025
December 2, 2025
Conditions
Outcome Measures
Primary Outcomes (1)
Pulp Vitality Recovery Assessed by Electric Pulp Test
Assessment of the percentage of treated teeth exhibiting a positive response to the Electric Pulp Test, indicating return of pulp vitality (revascularization or functional regeneration). Unit of Measure: % of teeth with positive EPT response Measurement Tool: Electric Pulp Test (EPT)
12 months after treatment
Secondary Outcomes (2)
Adverse Events Related to Transplantation Procedures
Throughout 12-month follow-up period
Pulp Vitality Recovery
12 months after treatment
Study Arms (3)
Conventional Root Canal Therapy
ACTIVE COMPARATORPatients undergo standard root canal preparation and obturation with gutta-percha and sealer using lateral condensation, followed by restoration.
Autologous dental pulp transplantation
ACTIVE COMPARATORHarvest of autologous third-molar pulp; canal disinfection; transplantation; MTA coronal seal; restoration.
Pulp transplantation with CGF
ACTIVE COMPARATORSame as pulp transplantation with the addition of autologous concentrated growth factor (CGF) placed over the transplanted pulp prior to MTA seal.
Interventions
Standard root canal instrumentation, irrigation, obturation with gutta-percha and sealer, and restoration.
Same as above, but CGF membrane placed over transplanted pulp before MTA sealing.
Harvest of autologous pulp tissue from third molar, canal disinfection, placement into recipient tooth, MTA sealing, composite restoration.
Eligibility Criteria
You may qualify if:
- Adults aged 18-40 years
- 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
You may not qualify if:
- Multi-rooted teeth or teeth with complex canal anatomy
- 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
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
ahramanmaraş Sütçü İmam University, Faculty of Dentistry
Kahramanmaraş, onikişubat, 46010, Turkey (Türkiye)
Related Publications (3)
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.
PMID: 35114270RESULTYan 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.
PMID: 36270575RESULTKim 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.
PMID: 39401572RESULT
Related Links
Study Officials
- PRINCIPAL INVESTIGATOR
Aliye Kamalak, Associate Professor Dr.
Kahramanmaraş Sütçü İmam University, Faculty of Dentistry, Department of Endodontics
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome evaluations and statistical analyses were performed by blinded examiners independent of the clinical operators.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Assoc Prof
Study Record Dates
First Submitted
November 20, 2025
First Posted
December 2, 2025
Study Start
November 5, 2023
Primary Completion
November 5, 2023
Study Completion
September 5, 2025
Last Updated
December 9, 2025
Record last verified: 2025-12
Data Sharing
- IPD Sharing
- Will share
- Shared Documents
- STUDY PROTOCOL, SAP
- Time Frame
- De-identified individual participant data and supporting documents will be available beginning 9 months after publication of the study results, with no fixed end date for data availability.
- Access Criteria
- Access will be granted to qualified researchers upon reasonable written request to the corresponding author (aliyekamalak@gmail.com). Requesters must provide a brief research proposal and obtain approval from the Institutional Ethics Committee. Data will be shared electronically in anonymized form.
De-identified individual participant data (IPD) that support the findings of this study will be available from the corresponding author upon reasonable request after publication. Data will include anonymized clinical outcomes and statistical analysis files, excluding any information that could compromise participant privacy.