Irreversible Pulpitis With Apical Periodontitis
Conditions
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.
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.
Interventions
PROCEDURERoot 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.
PROCEDUREPlatelet-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.
Sponsors
HITEC-Institute of Medical Sciences
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Investigator)
Intervention model description
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.
Eligibility
Sex/Gender
ALL
Age
16 Years to 50 Years
Healthy volunteers
No
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)
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Post-operative Pain Score | 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
| Measure | Time frame | Description |
|---|---|---|
| Periapical Healing Based on Periapical in Score | 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. |
Countries
Pakistan
Outcome results
None listed