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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

41 participants

Study Classification

INTERVENTIONAL

Study Start Date

2024-08-05

Study Completion Date

2025-08-04

Brief Summary

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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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Detailed Description

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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

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Irreversible Pulpitis With Apical Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Investigators

Study Groups

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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.

Group Type ACTIVE_COMPARATOR

Root Canal Therapy

Intervention Type 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

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.

Group Type EXPERIMENTAL

Platelet-Rich Plasma (PRP) Revascularization

Intervention Type 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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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)

Minimum Eligible Age

16 Years

Maximum Eligible Age

50 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No