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NCT Number: NCT07124962

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

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Key information

Conditions

Irreversible Pulpitis with Apical Periodontitis

Age range

16 year–50 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Dental hospial, Hitec-IMS

Rawalpindi, Punjab Province, Pakistan

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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)

Treatment and study plan

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.

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.

Primary outcomes

  1. Post-operative Pain Score

    Time frame: 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 outcomes

  1. Periapical Healing Based on Periapical in Score

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

HITEC-Institute of Medical Sciences

Other

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Aug 15, 2025
Registry last updated
Dec 4, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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