Pulpal RegenerationTRANSPNCT07258888
Pulp Transplantation in Necrotic Mature Teeth With Periapical Radiolucency
A study testing Conventional root canal therapy, Autologous dental pulp transplantation and Pulp transplantation with CGF in people with Pulpal Regeneration and Pulp Revascularization, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 40 years
- Conditions the study is for
- Pulpal Regeneration, Pulp Revascularization
- What is being tested?
- Conventional root canal therapy, Autologous dental pulp transplantation and Pulp transplantation with CGF
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 21 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 5 Nov 2023to 5 Sep 2025
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
ahramanmaraş Sütçü İmam University, Faculty of Dentistry
Kahramanmaraş, onikişubat, 46010
About this study
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).
Read the 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.
- Conditions
- Pulpal Regeneration, Pulp Revascularization
- Being tested
- Conventional root canal therapy, Autologous dental pulp transplantation, Pulp transplantation with CGF
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Conventional root canal therapyProcedure or surgery
Standard root canal instrumentation, irrigation, obturation with gutta-percha and sealer, and restoration.
Autologous dental pulp transplantationProcedure or surgery
Harvest of autologous pulp tissue from third molar, canal disinfection, placement into recipient tooth, MTA sealing, composite restoration.
Pulp transplantation with CGFProcedure or surgery
Same as above, but CGF membrane placed over transplanted pulp before MTA sealing.
| Study group | Role | What they receive |
|---|---|---|
| Conventional Root Canal Therapy | Active comparator | Patients undergo standard root canal preparation and obturation with gutta-percha and sealer using lateral condensation, followed by restoration. Receives: Procedure: Conventional root canal therapy |
| Autologous dental pulp transplantation | Active comparator | Harvest of autologous third-molar pulp; canal disinfection; transplantation; MTA coronal seal; restoration. Receives: Procedure: Autologous dental pulp transplantation |
| Pulp transplantation with CGF | Active comparator | Same as pulp transplantation with the addition of autologous concentrated growth factor (CGF) placed over the transplanted pulp prior to MTA seal. Receives: Procedure: Pulp transplantation with CGF |
What is being measured
The primary outcome is the main question the study is designed to answer.
Pulp Vitality Recovery Assessed by Electric Pulp Test
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)
Measured: 12 months after treatment
Secondary outcomes (2)
Adverse Events Related to Transplantation Procedures
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
Measured: Throughout 12-month follow-up period
Pulp Vitality Recovery
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)
Measured: 12 months after treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Dec 2025
- Study start5 Nov 2023
- Primary completion5 Nov 2023
- Study completion5 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Pulpal RegenerationStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 21 participants (actual)
Sponsor and investigators
- Lead sponsor
- Kahramanmaras Sutcu Imam University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Aliye Kamalak, Kahramanmaras Sutcu Imam University
- Investigators
- Aliye Kamalak, Associate Professor Dr., Principal investigator, Kahramanmaraş Sütçü İmam University, Faculty of Dentistry, Department of Endodontics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07258888
- Sponsor's protocol ID
- KSU-PT-2024-11
- Other IDs
- Project No: 2024/3-13D
- Acronym
- TRANSP
- Status last verified
- Dec 2025
- First submitted
- 20 Nov 2025
- Last updated
- 9 Dec 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: 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.
Publications
Cehreli ZC, Unverdi GE, Ballikaya E. Deciduous Tooth Pulp Autotransplantation for the Regenerative Endodontic Treatment of Permanent Teeth With Pulp Necrosis: A Case Series. J Endod. 2022 May;48(5):669-674. doi: 10.1016/j.joen.2022.01.015. Epub 2022 Feb 1.
PubMed 35114270Yan H, De Deus G, Kristoffersen IM, Wiig E, Reseland JE, Johnsen GF, Silva EJNL, Haugen HJ. Regenerative Endodontics by Cell Homing: A Review of Recent Clinical trials. J Endod. 2023 Jan;49(1):4-17. doi: 10.1016/j.joen.2022.09.008. Epub 2022 Oct 18.
PubMed 36270575Kim U, Kim S, Choi SM, Kang MK, Chang I, Kim E. Regenerative Endodontic Procedures With Minced Pulp Tissue Graft in Mature Permanent Teeth: A Clinical Study. J Endod. 2025 Jan;51(1):43-53.e2. doi: 10.1016/j.joen.2024.10.004. Epub 2024 Oct 12.
PubMed 39401572
Study at a glance
From the registry record, last updated by the sponsor on 9 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Pulp Transplantation in Necrotic Mature Teeth With Periapical Radiolucency
- ClinicalTrials.gov ID
- NCT07258888
- Acronym / sponsor ID
- TRANSP / KSU-PT-2024-11
- Conditions
- Pulpal Regeneration, Pulp Revascularization
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 21 participants (actual)
- Lead sponsor
- Kahramanmaras Sutcu Imam UniversityUniversity, hospital or other
- Study start
- 5 Nov 2023 (actual)
- Primary completion
- 5 Nov 2023 (actual)
- Study completion
- 5 Sep 2025 (actual)
- First posted
- 2 Dec 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 3
- 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.
| Arm | Type | Receives |
|---|---|---|
| Conventional Root Canal Therapy | Active comparator | Procedure: Conventional root canal therapyPatients undergo standard root canal preparation and obturation with gutta-percha and sealer using lateral condensation, followed by restoration. |
| Autologous dental pulp transplantation | Active comparator | Procedure: Autologous dental pulp transplantationHarvest of autologous third-molar pulp; canal disinfection; transplantation; MTA coronal seal; restoration. |
| Pulp transplantation with CGF | Active comparator | Procedure: Pulp transplantation with CGFSame as pulp transplantation with the addition of autologous concentrated growth factor (CGF) placed over the transplanted pulp prior to MTA seal. |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Conventional root canal therapyStandard root canal instrumentation, irrigation, obturation with gutta-percha and sealer, and restoration. | Procedure or surgery | Conventional Root Canal Therapy |
| Autologous dental pulp transplantationHarvest of autologous pulp tissue from third molar, canal disinfection, placement into recipient tooth, MTA sealing, composite restoration. | Procedure or surgery | Autologous dental pulp transplantation |
| Pulp transplantation with CGFSame as above, but CGF membrane placed over transplanted pulp before MTA sealing. | Procedure or surgery | Pulp transplantation with CGF |
Primary outcome
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)
2 secondary outcomes
Adverse Events Related to Transplantation Procedures
Time frame: Throughout 12-month follow-up period
Pulp Vitality Recovery
Time frame: 12 months after treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Dec 2025.
- Results publication: PubMed 35114270Cehreli ZC, Unverdi GE, Ballikaya E. Deciduous Tooth Pulp Autotransplantation for the Regenerative Endodontic Treatment of Permanent Teeth With Pulp Necrosis: A Case Series. J Endod. 2022 May;48(5):669-674. doi: 10.1016/j.joen.2022.01.015. Epub 2022 Feb 1.
- Results publication: PubMed 36270575Yan H, De Deus G, Kristoffersen IM, Wiig E, Reseland JE, Johnsen GF, Silva EJNL, Haugen HJ. Regenerative Endodontics by Cell Homing: A Review of Recent Clinical trials. J Endod. 2023 Jan;49(1):4-17. doi: 10.1016/j.joen.2022.09.008. Epub 2022 Oct 18.
- Results publication: PubMed 39401572Kim U, Kim S, Choi SM, Kang MK, Chang I, Kim E. Regenerative Endodontic Procedures With Minced Pulp Tissue Graft in Mature Permanent Teeth: A Clinical Study. J Endod. 2025 Jan;51(1):43-53.e2. doi: 10.1016/j.joen.2024.10.004. Epub 2024 Oct 12.
- Official website of the Faculty of Dentistry, Kahramanmaraş Sütçü İmam University - the institution where the study was conducted.Link provided by the sponsor.
- Individual participant dataSharing planned: Yes. 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.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Aliye Kamalak, Associate Professor Dr. principal investigator
Kahramanmaraş Sütçü İmam University, Faculty of Dentistry, Department of Endodontics
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Conventional root canal therapy, Autologous dental pulp transplantation and Pulp transplantation with CGF in people with Pulpal Regeneration and Pulp Revascularization, run by Kahramanmaras Sutcu Imam University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 9 Dec 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Pulp Vitality Recovery Assessed by Electric Pulp Test (time frame: 12 months after treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07258888, which also lists 3 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Dec 2025.