An interventional study of PRP-Assisted Regenerative Endodontic Treatment and Conventional Root Canal Treatment in Pulp Necrosis and Apical Periodontitis, sponsored by TC Erciyes University. Not yet recruiting at 1 site in Turkey (Türkiye). Open to participants aged 18 Years to 45 Years. Per ClinicalTrials.gov, last updated 2026-11-05.
Sponsored by TC Erciyes University · Not applicable, Interventional, and Treatment
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.
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.
157 studies on the registry are indexed under Dental Pulp Necrosis; 43 are open to participants now.
This study's planned enrollment of 10 is below the median of 45 across 147 interventional studies indexed under Dental Pulp Necrosis.
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Exclusion Criteria:
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.
Procedure: PRP-Assisted Regenerative Endodontic Treatment
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.
Procedure: Conventional Root Canal Treatment
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.
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.
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.
Time frame: Baseline to 12 months
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: 6, 12, and 24 months
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
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