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NCT07918664
PRP-Assisted Regenerative Endodontics Versus Conventional Root Canal Treatment in Mature Necrotic Teeth
Conditions: Pulp Necrosis, Apical Periodontitis
Sex: All
Ages: 18 Years – 45 Years
Healthy volunteers: No
Phase: NA
Enrollment: 10
Sponsor: TC Erciyes University
Location: Erciyes University Faculty of Dentistry Kayseri Kayseri
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.
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.
Eligibility Criteria
Inclusion Criteria:
* 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.
* 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.
Exclusion Criteria:
* 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.
* 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.
Source: ClinicalTrials.gov (NCT07918664). StuddyBuddy aggregates publicly available trial information.