PRP Regenerative Endodontics vs. Root Canal Treatment for Post-Op Pain and Healing in Mature Teeth

Not Applicable

Completed

• Conditions: Irreversible Pulpitis With Apical Periodontitis

• Registration Number: NCT07124962
• Lead Sponsor: HITEC-Institute of Medical Sciences

Brief Summary

This randomized clinical trial aims to compare the effectiveness of regenerative endodontic treatment using platelet-rich plasma (PRP) with conventional root canal treatment (RCT) in mature single-rooted teeth diagnosed with irreversible pulpitis and periapical lesions. The primary outcomes assessed will be post-operative pain and periapical healing. A total of 46 patients will be randomly assigned to either the PRP group or the RCT group. Pain will be recorded at baseline, 24, and 48 hours post-operatively using a numerical rating scale. Periapical healing will be evaluated clinically and radiographically at 1 and 6 months using the Periapical Index (PAI). The study aims to determine whether PRP-based regenerative therapy offers superior outcomes compared to conventional root canal therapy.

Detailed Description

This randomized clinical trial is designed to evaluate and compare the clinical efficacy of regenerative endodontics using platelet-rich plasma (PRP) versus conventional root canal treatment (RCT) in mature single-rooted permanent teeth diagnosed with irreversible pulpitis and radiographic signs of periapical pathology (PAI score 4).

Recent advancements in regenerative endodontics have demonstrated the potential for biologically-based procedures that not only disinfect the root canal system but also aim to regenerate the pulp-dentine complex and promote periapical healing. Platelet-rich plasma (PRP), a natural autologous scaffold derived from the patient's blood, contains growth factors such as PDGF, IGF, TGF-β, and EGF that enhance tissue healing, angiogenesis, and stem cell proliferation.

This trial will enroll 46 patients aged 16-50 years, who will be randomly allocated into two groups:

Group A (Control Group): Will undergo standard two-visit conventional RCT using lateral condensation technique and resin-based sealer.

Group B (Intervention Group): Will receive regenerative endodontic therapy using PRP revascularization. After canal disinfection with double antibiotic paste, bleeding will be induced, and PRP will be placed in the canal, followed by MTA and restoration.

Pain intensity will be assessed using the Numerical Rating Scale (NRS) at baseline, 24, and 48 hours postoperatively. Periapical healing will be evaluated clinically and radiographically at 1 month and 6 months using the Periapical Index (PAI). Treatment success will be defined as the absence of clinical symptoms and radiographic evidence of healing or reduction in PAI score.

The study aims to determine whether PRP-based regenerative endodontics can reduce post-operative pain more effectively and promote faster and better periapical healing compared to conventional root canal therapy in mature teeth.

Study Timeline

• Study Start: 2024-08-05
• Status Verified: 2025-08
• Primary Completion: 2025-08-04
• Study Completion: 2025-08-04
• Study First Submitted: 2025-08-11
• Study First Submitted QC: 2025-08-11
• Last Update Submitted: 2025-08-11
• Study First Posted: 2025-08-15
• Last Update Posted: 2025-08-15

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 41

Inclusion Criteria

• Mature single rooted teeth diagnosed with irreversible pulpitis presenting with radiographic signs of periapical lesions (PAI score 4)
• Patients that fall in the ages between 16-50 years

Exclusion Criteria

• Pregnant females
• Patients reporting with bruxism
• Teeth with severely curved canals
• Teeth with developmental anomalies, pathologic mobility, root fracture or a probing depth of >3mm
• Any allergy to medications or antibiotics (necessary to complete the procedure)

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Post-operative Pain Score	24 hours and 48 hours after second treatment visit	Patients will self-report pain levels on a 0-10 numerical rating scale, categorized as: 0 = no pain 1-3 = mild pain 4-6 = moderate pain 7-10 = severe pain Pain will be assessed by phone call at 24 and 48 hours after the second visit.

Secondary Outcome Measures

Name	Time	Method
Periapical Healing Based on Periapical in Score	1 month and 6 months post-treatment	Healing is evaluated using the Periapical Index (PAI) based on radiographs taken with the Digora system. Improvement in PAI score from baseline indicates periapical healing. Treatment is considered successful if the tooth is asymptomatic, not tender to percussion, shows no swelling, and demonstrates radiographic healing.

Trial Locations

Locations (1)

Dental hospial, Hitec-IMS; 🇵🇰 Rawalpindi, Punjab, Pakistan