Pulpal Regeneration, Pulp Revascularization
Conditions
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).
Detailed description
This study investigates the clinical applicability of autologous dental pulp transplantation as a potential biologic treatment alternative for necrotic mature teeth with periapical radiolucency. The trial explores whether transplantation of the patient's own pulp tissue, with or without the addition of concentrated growth factor (CGF), can promote tissue regeneration and functional recovery. The design includes three treatment groups to evaluate the effects of pulp transplantation alone, pulp transplantation combined with CGF, and conventional root canal therapy. 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.
Interventions
PROCEDUREConventional root canal therapy
Standard root canal instrumentation, irrigation, obturation with gutta-percha and sealer, and restoration.
PROCEDUREAutologous dental pulp transplantation
Harvest of autologous pulp tissue from third molar, canal disinfection, placement into recipient tooth, MTA sealing, composite restoration.
PROCEDUREPulp transplantation with CGF
Same as above, but CGF membrane placed over transplanted pulp before MTA sealing.
Sponsors
Kahramanmaras Sutcu Imam University
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)
Masking description
Outcome evaluations and statistical analyses were performed by blinded examiners independent of the clinical operators.
Intervention model description
This study used a parallel-group design with three treatment arms. Twenty-one patients with necrotic mature teeth were randomly assigned (1:1:1 ratio) to one of three groups: Group 1 received autologous dental pulp transplantation, Group 2 received pulp transplantation combined with concentrated growth factor (CGF), and Group 3 underwent conventional root canal therapy. Participants were followed for 12 months to evaluate pulp vitality and periapical healing.
Eligibility
Sex/Gender
ALL
Age
18 Years to 40 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Pulp Vitality Recovery Assessed by Electric Pulp Test | 12 months after treatment | 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) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Adverse Events Related to Transplantation Procedures | Throughout 12-month follow-up period | Incidence of postoperative pain, swelling, infection, or any other adverse event following treatment. Unit of Measure: % of participants experiencing any adverse event Measurement Tool: Clinical examination and patient-reported symptom assessment |
| Pulp Vitality Recovery | 12 months after treatment | Return of pulp vitality assessed by an electric pulp test (EPT). A positive response to EPT indicates revascularization or functional pulp regeneration after treatment. Unit of Measure: % of teeth with positive EPT response Measurement Tool: Electric Pulp Test (EPT) |
Countries
Turkey (Türkiye)
Outcome results
None listed