Pulp NecrosisNCT07918664
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
A study testing PRP-Assisted Regenerative Endodontic Treatment and Conventional Root Canal Treatment in people with Pulp Necrosis and Apical Periodontitis, run by TC Erciyes University at 1 site in Turkey (Türkiye).
Trial summary
This clinical trial will compare platelet-rich plasma (PRP)-assisted regenerative endodontic treatment with conventional root canal treatment in mature permanent teeth with pulp necrosis and apical periodontitis. Read more about this study
- Who is it for?
- Ages 18 to 45 years
- Conditions the study is for
- Pulp Necrosis, Apical Periodontitis
- What is being tested?
- PRP-Assisted Regenerative Endodontic Treatment and Conventional Root Canal Treatment
- Type of treatment
- Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 10 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- Jan 2027to Jun 2029
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 45 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-45 years.
- ASA physical status I or II.
- Two restorable mature permanent teeth suitable for paired allocation.
- Single-rooted, single-canal anatomy.
- Closed apices and completed root development.
- Diagnosis of pulp necrosis.
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- Radiographic evidence of apical periodontitis.
- Periapical Index (PAI) score ≥3 for both study teeth.
- Periapical radiolucency ≥5 mm at its greatest radiographic dimension for both study teeth.
- Periodontal probing depth ≤3 mm and absence of advanced periodontal disease.
- Absence of pathological mobility.
- Adequate coronal tooth structure for definitive restoration and feasibility of rubber-dam isolation.
- Ability and willingness to complete postoperative pain records and attend 6-, 12-, and 24-month follow-up visits.
Who cannot join
- Previous root canal treatment or previous endodontic surgery in either study tooth.
- More than one root or more than one root canal.
- Open apex, developmental anomaly, internal or external root resorption, root fracture, or suspected vertical root fracture.
- Severe canal curvature or anatomy incompatible with standardized instrumentation.
- Non-restorable tooth or inability to obtain adequate isolation.
- Periodontal attachment loss or periodontal probing depth >3 mm.
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- Pregnancy or breastfeeding.
- Systemic disease or medication likely to substantially alter inflammation, coagulation, pain perception, or healing.
- Use of analgesics, anti-inflammatory drugs, systemic corticosteroids, or antibiotics within the predefined preoperative period.
- Inability to comply with postoperative or long-term follow-up.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Turkey (Türkiye)1 site
Erciyes University Faculty of Dentistry
Kayseri, Kayseri, 38039
ipek eraslan akyüz, DDS, +90 352 207 6600 ext. 29128, ipekemamak@hotmail.com
About this study
Official title: PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth: A Clinical Trial
This clinical trial will compare platelet-rich plasma (PRP)-assisted regenerative endodontic treatment with conventional root canal treatment in mature permanent teeth with pulp necrosis and apical periodontitis.
Ten participants will be included, and each participant will contribute two eligible single-rooted, single-canal teeth. Within each participant, one tooth will receive PRP-assisted regenerative endodontic treatment and the other tooth will receive conventional root canal treatment.
The primary objective is to compare radiographic periapical healing between the two treatments at 12 months. Secondary outcomes will include postoperative pain, analgesic use, clinical signs and symptoms, pulp sensibility, treatment success, tooth survival, and adverse events. Clinical and radiographic follow-up will be performed at 6, 12, and 24 months.
Read the detailed description
This prospective, single-center, within-patient clinical trial will evaluate platelet-rich plasma (PRP)-assisted regenerative endodontic treatment compared with conventional root canal treatment in mature permanent teeth with pulp necrosis and apical periodontitis.
Ten participants will be enrolled, and each participant will contribute two eligible mature, single-rooted, single-canal permanent teeth. Within each participant, one tooth will receive PRP-assisted regenerative endodontic treatment and the paired tooth will receive conventional root canal treatment. This paired design allows each participant to serve as his or her own control and is intended to reduce the influence of interindividual variability.
Both study teeth will undergo standardized chemomechanical preparation, irrigation, intracanal medication with calcium hydroxide, and a second treatment visit. In the PRP-assisted regenerative treatment arm, autologous PRP will be prepared from venous blood and introduced into the root canal after controlled apical stimulation. A bioceramic coronal barrier will then be placed, followed by definitive coronal restoration. In the conventional root canal treatment arm, the canal will be obturated with gutta-percha and bioceramic sealer and definitively restored.
Postoperative pain will be recorded separately for each study tooth at 6, 12, 24, and 48 hours and on days 3 through 7. Analgesic use will also be recorded.
Clinical and radiographic follow-up will be performed at 6, 12, and 24 months. The primary outcome will be radiographic periapical healing at 12 months, expressed as the percentage reduction in standardized periapical lesion area relative to baseline. Secondary outcomes will include postoperative pain trajectory, analgesic consumption, Periapical Index scores, complete radiographic healing, clinical success, cold and electric pulp sensibility responses, tooth survival, and adverse events.
Radiographic assessments will be performed using standardized periapical radiographs. Outcome assessors will be blinded to treatment allocation, and radiographic measurements will be performed by calibrated examiners.
- Conditions
- Pulp Necrosis, Apical Periodontitis
- Being tested
- PRP-Assisted Regenerative Endodontic Treatment, Conventional Root Canal Treatment
- Keywords
- Regenerative Endodontics, Platelet-Rich Plasma, Root Canal Treatment, Mature Permanent Teeth, Periapical Healing, Postoperative Pain
- Medical subject headings
- Dental Pulp Necrosis, Periapical Periodontitis, Pain, Postoperative
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PRP-Assisted Regenerative Endodontic TreatmentProcedure or surgery
After standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, autologous platelet-rich plasma is prepared from venous blood and introduced into the root canal at the second visit after controlled apical stimulation. A Biodentine coronal barrier is placed, followed by definitive resin composite restoration.
Conventional Root Canal TreatmentProcedure or surgery
After standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, the root canal is obturated at the second visit with gutta-percha and NeoSealer Flo bioceramic sealer using the cold lateral condensation technique. The access cavity is then definitively restored with resin composite.
| Study group | Role | What they receive |
|---|---|---|
| PRP-Assisted Regenerative Endodontic Treatment | Experimental | Participants will receive PRP-assisted regenerative endodontic treatment in one eligible mature necrotic tooth. After standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, autologous platelet-rich plasma will be prepared from venous blood and introduced into the root canal at the second visit after controlled apical stimulation. A Biodentine coronal barrier will then be placed, followed by definitive resin composite restoration. Receives: Procedure: PRP-Assisted Regenerative Endodontic Treatment |
| Conventional Root Canal Treatment | Active comparator | Participants will receive conventional root canal treatment in the paired eligible mature necrotic tooth. After standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, the canal will be obturated at the second visit with gutta-percha and NeoSealer Flo bioceramic sealer using the cold lateral condensation technique. The access cavity will then be definitively restored with resin composite. Receives: Procedure: Conventional Root Canal Treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage Reduction in Periapical Lesion Area
Periapical lesion area will be measured on standardized digital periapical radiographs by calibrated blinded examiners using validated image-analysis software. Percentage lesion reduction will be calculated as [(baseline lesion area - 12-month lesion area) / baseline lesion area] × 100. Higher percentage values indicate greater radiographic healing.
Measured: Baseline to 12 months
Secondary outcomes (6)
Postoperative Pain Intensity
Postoperative pain will be recorded separately for each study tooth using a 100-mm visual analogue scale (VAS), where 0 represents no pain and 100 represents the worst imaginable pain. Participants will record tooth-specific pain scores at each predefined postoperative time point.
Measured: 6, 12, 24, and 48 hours and days 3, 4, 5, 6, and 7 after treatment
Analgesic Consumption
Analgesic use will be recorded for each study tooth during the postoperative follow-up period. Participants will record the time and number of analgesic doses taken. Ibuprofen 400 mg will be recommended when required, with paracetamol 500 mg used when ibuprofen is contraindicated.
Measured: From treatment through postoperative day 7
Periapical Index Score
Periapical healing will be assessed using the Periapical Index (PAI) on standardized periapical radiographs. PAI scores will be determined by calibrated blinded examiners at each follow-up visit.
Measured: 6, 12, and 24 months
Complete Radiographic Healing
Complete radiographic healing will be assessed on standardized periapical radiographs by calibrated blinded examiners. Complete healing will be recorded when the periapical radiolucency has resolved and no radiographic evidence of progressive periapical disease is present.
Measured: 6, 12, and 24 months
Clinical Success
Clinical success will be defined as a functional tooth without spontaneous pain, tenderness to percussion or palpation, swelling, sinus tract, or evidence of progressive periapical disease. Teeth requiring nonsurgical retreatment, endodontic surgery, extraction, or another intervention because of persistent endodontic disease will be classified as failures.
Measured: 6, 12, and 24 months
Pulp Sensibility Response
Pulp sensibility will be assessed using cold testing and electric pulp testing at follow-up visits. A positive response to either sensibility test will be recorded for each study tooth.
Measured: 6, 12, and 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Nov 2026
- Study startJan 2027 (estimated)
- Primary completionJun 2028 (estimated)
- Study completionJun 2029 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pulp NecrosisStudies of the same condition, open and under way.
- More trials run by TC Erciyes UniversityThe sponsor's other registered studies.
- 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
- Non-randomised
- Intervention model
- Parallel groups
- Model description
- Within-patient paired design. Each participant contributes two eligible mature necrotic teeth. Within each participant, one tooth receives PRP-assisted regenerative endodontic treatment and the paired tooth receives conventional root canal treatment. Each participant therefore serves as his or her own control.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 10 participants (estimated)
Sponsor and investigators
- Lead sponsor
- TC Erciyes University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Ipek Eraslan Akyuz, TC Erciyes University
- Investigators
- ipek eraslan akyüz, DDS, Principal investigator, TC Erciyes University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07918664
- Sponsor's protocol ID
- ERU-ENDO-PRPREP-RCT-2026
- Status last verified
- Nov 2026
- First submitted
- 1 Nov 2026
- Last updated
- 5 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 5 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth: A Clinical Trial
- ClinicalTrials.gov ID
- NCT07918664
- Acronym / sponsor ID
- ERU-ENDO-PRPREP-RCT-2026
- Conditions
- Pulp Necrosis, Apical Periodontitis
- Keywords
- Regenerative Endodontics, Platelet-Rich Plasma, Root Canal Treatment, Mature Permanent Teeth, Periapical Healing, Postoperative Pain
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 10 participants (estimated)
- Lead sponsor
- TC Erciyes UniversityUniversity, hospital or other
- Study start
- Jan 2027 (estimated)
- Primary completion
- Jun 2028 (estimated)
- Study completion
- Jun 2029 (estimated)
- First posted
- 5 Nov 2026 (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 clinical trial will compare platelet-rich plasma (PRP)-assisted regenerative endodontic treatment with conventional root canal treatment in mature permanent teeth with pulp necrosis and apical periodontitis.
Ten participants will be included, and each participant will contribute two eligible single-rooted, single-canal teeth. Within each participant, one tooth will receive PRP-assisted regenerative endodontic treatment and the other tooth will receive conventional root canal treatment.
The primary objective is to compare radiographic periapical healing between the two treatments at 12 months. Secondary outcomes will include postoperative pain, analgesic use, clinical signs and symptoms, pulp sensibility, treatment success, tooth survival, and adverse events. Clinical and radiographic follow-up will be performed at 6, 12, and 24 months.
Detailed description
This prospective, single-center, within-patient clinical trial will evaluate platelet-rich plasma (PRP)-assisted regenerative endodontic treatment compared with conventional root canal treatment in mature permanent teeth with pulp necrosis and apical periodontitis.
Ten participants will be enrolled, and each participant will contribute two eligible mature, single-rooted, single-canal permanent teeth. Within each participant, one tooth will receive PRP-assisted regenerative endodontic treatment and the paired tooth will receive conventional root canal treatment. This paired design allows each participant to serve as his or her own control and is intended to reduce the influence of interindividual variability.
Both study teeth will undergo standardized chemomechanical preparation, irrigation, intracanal medication with calcium hydroxide, and a second treatment visit. In the PRP-assisted regenerative treatment arm, autologous PRP will be prepared from venous blood and introduced into the root canal after controlled apical stimulation. A bioceramic coronal barrier will then be placed, followed by definitive coronal restoration. In the conventional root canal treatment arm, the canal will be obturated with gutta-percha and bioceramic sealer and definitively restored.
Postoperative pain will be recorded separately for each study tooth at 6, 12, 24, and 48 hours and on days 3 through 7. Analgesic use will also be recorded.
Clinical and radiographic follow-up will be performed at 6, 12, and 24 months. The primary outcome will be radiographic periapical healing at 12 months, expressed as the percentage reduction in standardized periapical lesion area relative to baseline. Secondary outcomes will include postoperative pain trajectory, analgesic consumption, Periapical Index scores, complete radiographic healing, clinical success, cold and electric pulp sensibility responses, tooth survival, and adverse events.
Radiographic assessments will be performed using standardized periapical radiographs. Outcome assessors will be blinded to treatment allocation, and radiographic measurements will be performed by calibrated examiners.
Study design
- Primary purpose
- Treatment
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Within-patient paired design. Each participant contributes two eligible mature necrotic teeth. Within each participant, one tooth receives PRP-assisted regenerative endodontic treatment and the paired tooth receives conventional root canal treatment. Each participant therefore serves as his or her own control.
| Arm | Type | Receives |
|---|---|---|
| PRP-Assisted Regenerative Endodontic Treatment | Experimental | Procedure: PRP-Assisted Regenerative Endodontic TreatmentParticipants will receive PRP-assisted regenerative endodontic treatment in one eligible mature necrotic tooth. After standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, autologous platelet-rich plasma will be prepared from venous blood and introduced into the root canal at the second visit after controlled apical stimulation. A Biodentine coronal barrier will then be placed, followed by definitive resin composite restoration. |
| Conventional Root Canal Treatment | Active comparator | Procedure: Conventional Root Canal TreatmentParticipants will receive conventional root canal treatment in the paired eligible mature necrotic tooth. After standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, the canal will be obturated at the second visit with gutta-percha and NeoSealer Flo bioceramic sealer using the cold lateral condensation technique. The access cavity will then be definitively restored with resin composite. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (13 listed)
- Age 18-45 years.
- ASA physical status I or II.
- Two restorable mature permanent teeth suitable for paired allocation.
- Single-rooted, single-canal anatomy.
- Closed apices and completed root development.
Key exclusion criteria (10 listed)
- Previous root canal treatment or previous endodontic surgery in either study tooth.
- More than one root or more than one root canal.
- Open apex, developmental anomaly, internal or external root resorption, root fracture, or suspected vertical root fracture.
- Severe canal curvature or anatomy incompatible with standardized instrumentation.
- Non-restorable tooth or inability to obtain adequate isolation.
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 |
|---|---|---|
| PRP-Assisted Regenerative Endodontic TreatmentAfter standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, autologous platelet-rich plasma is prepared from venous blood and introduced into the root canal at the second visit after controlled apical stimulation. A Biodentine coronal barrier is placed, followed by definitive resin composite restoration. | Procedure or surgery | PRP-Assisted Regenerative Endodontic Treatment |
| Conventional Root Canal TreatmentAfter standardized chemomechanical preparation, irrigation, and intracanal medication with calcium hydroxide, the root canal is obturated at the second visit with gutta-percha and NeoSealer Flo bioceramic sealer using the cold lateral condensation technique. The access cavity is then definitively restored with resin composite. | Procedure or surgery | Conventional Root Canal Treatment |
Primary outcome
Percentage Reduction in Periapical Lesion Area
Time frame: Baseline to 12 months
Periapical lesion area will be measured on standardized digital periapical radiographs by calibrated blinded examiners using validated image-analysis software. Percentage lesion reduction will be calculated as [(baseline lesion area - 12-month lesion area) / baseline lesion area] × 100. Higher percentage values indicate greater radiographic healing.
6 secondary outcomes
Postoperative Pain Intensity
Time frame: 6, 12, 24, and 48 hours and days 3, 4, 5, 6, and 7 after treatment
Analgesic Consumption
Time frame: From treatment through postoperative day 7
Periapical Index Score
Time frame: 6, 12, and 24 months
Complete Radiographic Healing
Time frame: 6, 12, and 24 months
Clinical Success
Time frame: 6, 12, and 24 months
Pulp Sensibility Response
Time frame: 6, 12, and 24 months
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2026.
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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.
ipek eraslan akyüz, DDS principal investigator
TC Erciyes University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PRP-Assisted Regenerative Endodontic Treatment and Conventional Root Canal Treatment in people with Pulp Necrosis and Apical Periodontitis, run by TC Erciyes 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 13 inclusion and 10 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: opening soon, as of the sponsor's last update on 5 Nov 2026. 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact ipek eraslan akyüz, DDS (+90 352 207 6600 ext. 29128, ipekemamak@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Percentage Reduction in Periapical Lesion Area (time frame: Baseline to 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 5 Nov 2026.