Pulp Transplantation in Necrotic Mature Teeth With Periapical Radiolucency (TRANSP)

Kahramanmaraş Sütçü İmam University (KSU)

Status: Completed

Conditions: Pulpal Regeneration; Pulp Revascularization

Treatments: Procedure: Conventional root canal therapy; Procedure: Pulp transplantation with CGF; Procedure: Autologous dental pulp transplantation

Study type: Interventional

Funder types: Other

Identifiers

NCT07258888

KSU-PT-2024-11

Project No: 2024/3-13D (Other Grant/Funding Number)

Details and patient eligibility

About

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).

Full 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.

Enrollment: 21 patients

Sex: All

Ages: 18 to 40 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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21 participants in 3 patient groups

Conventional Root Canal Therapy

Active Comparator group

Description:

Patients undergo standard root canal preparation and obturation with gutta-percha and sealer using lateral condensation, followed by restoration.

Treatment:

Procedure: Conventional root canal therapy

Autologous dental pulp transplantation

Active Comparator group

Description:

Harvest of autologous third-molar pulp; canal disinfection; transplantation; MTA coronal seal; restoration.

Treatment:

Procedure: Autologous dental pulp transplantation

Pulp transplantation with CGF

Active Comparator group

Description:

Same as pulp transplantation with the addition of autologous concentrated growth factor (CGF) placed over the transplanted pulp prior to MTA seal.

Treatment:

Procedure: Pulp transplantation with CGF