NCT07124962

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

Comparison of Post Operative Pain and Periapical Healing Following Regenerative Endodontics Using Platelet Rich Plasma vs Conventional Root Canal Treatment in Mature Single Rooted Teeth

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 41 (actual)
• Sponsor: HITEC-Institute of Medical Sciences · Academic / Other
• Sex: All
• Age: 16 Years – 50 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Irreversible Pulpitis With Apical Periodontitis

Interventions

Type	Name	Description
PROCEDURE	Root Canal Therapy	Regenerative endodontic procedure using autologous platelet-rich plasma injected into the root canal space to promote pulp-dentin regeneration, followed by placement of MTA and composite restoration.
PROCEDURE	Platelet-Rich Plasma (PRP) Revascularization	Regenerative endodontic procedure using autologous platelet-rich plasma injected into the root canal space to promote pulp-dentin regeneration, followed by placement of MTA and composite restoration.

Timeline

• Start date: 2024-08-05
• Primary completion: 2025-08-04
• Completion: 2025-08-04
• First posted: 2025-08-15
• Last updated: 2025-12-04

Locations

1 site across 1 country: Pakistan