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

NCT07124962 | Completed DMC

• 1 other identifier: Dr Fatimah Arshad
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

Irreversible Pulpitis With Apical Periodontitis

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• Periapical Healing Based on Periapical in Score

  1 month and 6 months post-treatment

Study Arms (2)

Conventional Root Canal Treatment (RCT)

ACTIVE COMPARATOR

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

PRP Revascularization

EXPERIMENTAL

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

Interventions

Root Canal Therapy PROCEDURE

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.

Conventional Root Canal Treatment (RCT)

Platelet-Rich Plasma (PRP) Revascularization PROCEDURE

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.

PRP Revascularization

Eligibility Criteria

• Age: 16 Years - 50 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• HITEC-Institute of Medical Sciences: lead

Study Sites (1)

Dental hospial, Hitec-IMS

Rawalpindi, Punjab Province, Pakistan

Location

Related Publications (1)

• 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.

  PMID: 36565044 RESULT

MeSH Terms

Interventions

Root Canal Therapy

Intervention Hierarchy (Ancestors)

Endodontics; Dentistry

Study Officials

• Dr. Beenish Qureshi, BDS, FCPS

  HITEC-Institute of Medical Sciences

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Model Details: Participants will be randomly assigned to one of two treatment groups in parallel. Each participant will receive either regenerative endodontic treatment using platelet-rich plasma (PRP) or conventional root canal treatment (RCT). Both groups will be treated and followed simultaneously, and outcomes including post-operative pain and periapical healing will be compared between groups. No crossover or switching of interventions will occur.

Study Record Dates

• First Submitted: August 11, 2025
• First Posted: August 15, 2025
• Study Start: August 5, 2024
• Primary Completion: August 4, 2025
• Study Completion: August 4, 2025
• Last Updated: December 4, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will not share

Locations

PA (1)