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

HITEC-Institute of Medical Sciences

Status: Completed

Conditions: Irreversible Pulpitis With Apical Periodontitis

Treatments: Procedure: Root Canal Therapy; Procedure: Platelet-Rich Plasma (PRP) Revascularization

Study type: Interventional

Funder types: Other

Identifiers

NCT07124962

Dr Fatimah Arshad

Details and patient eligibility

About

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.

Full 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.

Enrollment: 41 patients

Sex: All

Ages: 16 to 50 years old

Volunteers: No Healthy Volunteers

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)

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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41 participants in 2 patient groups

Conventional Root Canal Treatment (RCT)

Active Comparator group

Description:

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.

Treatment:

Procedure: Root Canal Therapy

PRP Revascularization

Experimental group

Description:

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.

Treatment:

Procedure: Platelet-Rich Plasma (PRP) Revascularization