Clinical and Radiographic Success of Regeneration Using Injectable Platelet Rich Fibrin Versus Root Canal Treatment in Mature Permanent Molars With Apical Periodontitis: A Randomized Controlled Pilot Study
Trial Snapshot
- Phase
- Not Applicable
- Status
- Not yet recruiting
- Sponsor
- Cairo University
- Enrollment
- 50
- Primary Endpoint
- Clinical success
Study Overview
Brief Summary
Study aimed at assessing the clinical and radiographic success of pulp regeneration using injectable platelet-rich fibrin in mature permanent molars with apical periodontitis versus root canal treatment using Gutta Percha (GP) obturation.
Detailed Description
Randomized pilot study, parallel groups design with 1:1 allocation ratio.
PICOT:
Population: Mature first permanent molar with apical periodontitis. Intervention: Regeneration using injectable platelet-rich fibrin. Control: Root canal treatment using GP obturation. outcomes: clinical and radiographic success. Source of patients: this study will be conducted in the outpatient postgraduate clinic of the Pediatric Dentistry and Dental Public Health Department - Faculty of Dentistry, Cairo University, Egypt.
Written Informed consent from participating children/parents. Baseline records photographs, clinical inspection, percussion test, periapical radiograph, and personal data collection will be conducted.
A diagnostic chart with personal, medical, and dental history will be filled Diagnosis and treatment of the cases will be performed according to the Treatment Standards of the American Association of Endodontists (AAE) 2020 of Non-Surgical Endodontics for the Uncomplicated Mature Permanent Teeth.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 10 Years to 15 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Children aged between 10-15 years.
- •First Permanent molar diagnosed with apical periodontitis.
- •A cooperative and compliant patient/ parent.
- •Patients not allergic to medicaments necessary to complete the procedure.
- •Patients with no history of chronic systemic diseases.
Exclusion Criteria
- •Teeth indicated for post and core.
- •Non-restorable tooth.
- •Previous root canal treatment.
- •Curved canal of more than 25°.
- •Periodontal pocket larger than 3 mm.
- •Teeth with developmental anomalies.
Outcomes
Primary Outcomes
Clinical success
Time Frame: 1, 3, 6, 9 and 12 months
Clinical Success is a composite outcome and will be recorded as Clinically Successful or Clinically Unsuccessful based on the following evaluation criteria: Clinically Successful: Following assigned treatment in case of absence of all of the following: spontaneous pain, swelling, sinus tract, palpation pain, percussion pain. Clinically unsuccessful: Following assigned treatment in case of presence of any of the following: spontaneous pain, swelling, sinus tract, palpation pain, percussion pain.
Secondary Outcomes
- Radiographic success(6 and 12 months)
- Overall success(6 and 12 months)
Investigators
Samah Mohsen Kanzel
Pediatric Dentist
Cairo University