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NCT Number: NCT07258888

Pulp Transplantation in Necrotic Mature Teeth With Periapical Radiolucency

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).

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Key information

Conditions

Pulpal Regeneration Pulp Revascularization

Age range

18 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

ahramanmaraş Sütçü İmam University, Faculty of Dentistry

Kahramanmaraş, onikişubat, 46010, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Conventional root canal therapy

Procedure

Standard root canal instrumentation, irrigation, obturation with gutta-percha and sealer, and restoration.

Autologous dental pulp transplantation

Procedure

Harvest of autologous pulp tissue from third molar, canal disinfection, placement into recipient tooth, MTA sealing, composite restoration.

Pulp transplantation with CGF

Procedure

Same as above, but CGF membrane placed over transplanted pulp before MTA sealing.

Primary outcomes

  1. Pulp Vitality Recovery Assessed by Electric Pulp Test

    Time frame: 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 outcomes

  1. Adverse Events Related to Transplantation Procedures

    Time frame: 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

  2. Pulp Vitality Recovery

    Time frame: 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)

Sponsors and collaborators

Lead sponsor

Kahramanmaras Sutcu Imam University

Other

Registry information

Acronym: TRANSP

Important dates

Study start
2023
Primary completion
2023
Study completion
2025
First posted
Dec 2, 2025
Registry last updated
Dec 9, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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