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

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.

Study Overview

• Status: Completed
• Conditions: Irreversible Pulpitis With Apical Periodontitis
• Intervention / Treatment: Procedure: Root Canal Therapy; Procedure: Platelet-Rich Plasma (PRP) Revascularization

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 Type: Interventional
• Enrollment (Actual): 41
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Pakistan
  • Punjab Province
    • Rawalpindi, Punjab Province, Pakistan
      • Dental hospial, Hitec-IMS

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: Conventional Root Canal Treatment (RCT); Patients will undergo conventional root canal therapy, including canal preparation using hand k-files (#10-#45), irrigation with 3% sodium hypochlorite, and obturation using lateral condensation technique with resin-based sealer. The access cavity will be restored using Glass Ionomer Cement.	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.
Experimental: PRP Revascularization; After canal disinfection and removal of double antibiotic paste, PRP derived from autologous blood will be injected into the canal space after inducing bleeding through over-instrumentation. A layer of Mineral Trioxide Aggregate (MTA) will be placed, followed by temporary GIC and final composite restoration after 7 days.	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Post-operative Pain Score	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.	24 hours and 48 hours after second treatment visit

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Periapical Healing Based on Periapical in Score	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.	1 month and 6 months post-treatment

Collaborators and Investigators

• Sponsor: HITEC-Institute of Medical Sciences
• Investigators: Study Chair: Dr. Beenish Qureshi, BDS, FCPS, HITEC-Institute of Medical Sciences

Publications and helpful links

General Publications

• Ahmed YE, Ahmed GM, Ghoneim AG. Evaluation of postoperative pain and healing following regenerative endodontics using platelet-rich plasma versus conventional endodontic treatment in necrotic mature mandibular molars with chronic periapical periodontitis. A randomized clinical trial. Int Endod J. 2023 Apr;56(4):404-418. doi: 10.1111/iej.13886. Epub 2023 Jan 12.

Study record dates

Study Major Dates

• Study Start (Actual): August 5, 2024
• Primary Completion (Actual): August 4, 2025
• Study Completion (Actual): August 4, 2025

Study Registration Dates

• First Submitted: August 11, 2025
• First Submitted That Met QC Criteria: August 11, 2025
• First Posted (Actual): August 15, 2025

Study Record Updates

• Last Update Posted (Estimated): December 4, 2025
• Last Update Submitted That Met QC Criteria: November 27, 2025
• Last Verified: November 1, 2025

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Periapical Diseases; Jaw Diseases; Dental Pulp Diseases; Tooth Diseases; Periodontitis; Periapical Periodontitis; Pulpitis; Dentistry; Endodontics; Root Canal Therapy
• Other Study ID Numbers: Dr Fatimah Arshad

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No