An interventional study of Conventional Root Canal Treatment and Regenerative Endodontic Treatment with i-PRF in Chronic Apical Periodontitis and Pulp Necrosis, sponsored by Medipol University. Not yet recruiting. Open to participants aged 10 Years to 45 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-11-03.
Sponsored by Medipol University · Not applicable, Interventional, and Treatment
This randomized clinical trial aims to compare regenerative endodontic treatment using injectable platelet-rich fibrin (i-PRF) with conventional root canal treatment in mature necrotic anterior teeth with chronic apical periodontitis. Clinical and radiographic healing, inflammatory biomarkers in gingival crevicular fluid (IL-1β, IL-6, TNF-α), postoperative pain, analgesic intake, and pulp vitality recovery will be evaluated over a 6-month follow-up. A healthy control group will be included for comparison of inflammatory biomarker levels.
This single-center, randomized, controlled clinical trial will include 120 participants divided into three groups: a healthy control group (n=40), a conventional root canal treatment group (n=40), and a regenerative endodontic treatment with injectable platelet-rich fibrin (i-PRF) group (n=40).
Baseline clinical and radiographic examinations will include periapical radiographs, pulp vitality tests (cold test and electric pulp test), periodontal assessment, lesion size, Periapical Index (PAI), pain assessment using a visual analogue scale (VAS), and collection of gingival crevicular fluid (GCF) samples for inflammatory biomarker analysis (IL-1β, IL-6, and TNF-α).
All teeth in the treatment groups will receive standardized chemomechanical preparation and calcium hydroxide intracanal medication during the first visit. After three weeks, participants will be randomly assigned to receive either conventional root canal treatment with mineral trioxide aggregate (MTA) obturation or regenerative endodontic treatment using induced bleeding, injectable platelet-rich fibrin (i-PRF), CollaCote membrane, and MTA. Blood samples collected from both treatment groups will be analyzed for growth factors (TGF-β, IGF, and FGF) using ELISA.
Postoperative pain will be recorded using VAS at 12 hours, 24 hours, 3 days, and 7 days. Analgesic intake and postoperative swelling will also be documented.
At the 6-month follow-up, clinical examination, periapical radiography, gingival crevicular fluid sampling, and pulp vitality testing will be repeated. The primary outcome will be clinical and radiographic healing based on modified Periapical Index (PAI) criteria. Secondary outcomes include changes in inflammatory biomarker levels, postoperative pain intensity, analgesic consumption, postoperative swelling, and recovery of pulp vitality in the regenerative treatment group.
156 studies on the registry are indexed under Dental Pulp Necrosis; 42 are open to participants now.
This study's planned enrollment of 120 is above the median of 45 across 146 interventional studies indexed under Dental Pulp Necrosis.
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Exclusion Criteria:
Healthy participants without apical periodontitis or periodontal disease. No intervention will be performed. Gingival crevicular fluid samples will be collected at baseline and at the 6-month follow-up for inflammatory biomarker analysis.
Participants with chronic apical periodontitis treated with conventional root canal treatment according to the study protocol.
Procedure: Conventional Root Canal Treatment
Participants with chronic apical periodontitis treated with regenerative endodontic treatment using injectable platelet-rich fibrin (i-PRF) according to the study protocol.
Procedure: Regenerative Endodontic Treatment with i-PRF · Biological: Injectable Platelet-Rich Fibrin (i-PRF)
Conventional root canal treatment performed according to the study protocol using chemomechanical preparation, calcium hydroxide intracanal medication, and mineral trioxide aggregate (MTA) obturation.
Regenerative endodontic treatment performed using induced bleeding, injectable platelet-rich fibrin (i-PRF), CollaCote membrane, and mineral trioxide aggregate (MTA) according to the study protocol.
Autologous injectable platelet-rich fibrin prepared from the participant's peripheral blood and used as a scaffold during regenerative endodontic treatment.
Periapical Radiographic Healing Evaluated by Modified Periapical Index (PAI) Score
Radiographic evaluation of periapical tissue status and bone healing on standardized parallel periapical radiographs using the unabbreviated Modified Periapical Index (PAI) scale. The PAI is a 5-point scale ranging from 1 to 5: minimum value = 1 (normal periapical structure / complete healing / best outcome), maximum value = 5 (severe periodontitis with exacerbating features / worse outcome). Higher scores represent worse periapical status (worse outcome).
Time frame: Baseline and 6 months post-treatment
Clinical Treatment Success Rate
Percentage of participants achieving complete clinical treatment success, defined as the absence of all clinical signs and symptoms (spontaneous pain, tenderness to percussion, tenderness to palpation, swelling, and sinus tract) along with normal tooth function.
Time frame: 6 months post-treatment
Postoperative Pain Intensity Evaluated by Visual Analog Scale (VAS)
Self-reported postoperative pain intensity measured using the unabbreviated Visual Analog Scale (VAS). The VAS is a 10-point scale ranging from 0 to 10: minimum value = 0 (no pain / best outcome), maximum value = 10 (worst imaginable pain / worse outcome). Higher scores represent higher pain intensity (worse outcome).
Time frame: 12 hours, 24 hours, Day 3, and Day 7 after the second treatment session
Analgesic Consumption
Number of ibuprofen tablets taken after treatment will be recorded based on patient diaries.
Time frame: From the second treatment session to Day 7
Pulp Vitality Response
Recovery of pulp vitality will be evaluated using cold testing and electric pulp testing (EPT). EPT measurements will be performed twice and the numerical values will be recorded. Responses will be categorized as normal, sensitive, dull, or no response.
Time frame: 6 months after treatment
Gingival Crevicular Fluid Inflammatory Biomarkers
Levels of IL-1β, IL-6, and TNF-α in gingival crevicular fluid will be measured and compared between baseline and the 6-month follow-up.
Time frame: Baseline and 6 months
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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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