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).

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.

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

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.

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 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.

Outcome evaluations and statistical analyses were performed by blinded examiners independent of the clinical operators.