Pulp Transplantation in Necrotic Mature Teeth With Periapical Radiolucency
NCT07258888 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 21
Last updated 2025-12-09
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).
Conditions
- Pulpal Regeneration
- Pulp Revascularization
Interventions
- PROCEDURE
-
Conventional root canal therapy
Standard root canal instrumentation, irrigation, obturation with gutta-percha and sealer, and restoration.
- PROCEDURE
-
Autologous dental pulp transplantation
Harvest of autologous pulp tissue from third molar, canal disinfection, placement into recipient tooth, MTA sealing, composite restoration.
- PROCEDURE
-
Pulp transplantation with CGF
Same as above, but CGF membrane placed over transplanted pulp before MTA sealing.
Sponsors & Collaborators
-
Kahramanmaras Sutcu Imam University
lead OTHER
Principal Investigators
-
Aliye Kamalak, Associate Professor Dr. · Kahramanmaraş Sütçü İmam University, Faculty of Dentistry, Department of Endodontics
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- SINGLE
- Model
- PARALLEL
Eligibility
- Min Age
- 18 Years
- Max Age
- 40 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2023-11-05
- Primary Completion
- 2023-11-05
- Completion
- 2025-09-05
Countries
- Turkey (Türkiye)
Study Locations
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