Status:
NOT_YET_RECRUITING
Clinical and Radiographic Evaluation of Indirect Pulp Capping Using Platelet Rich Fibrin Versus Mineral Trioxide Aggregate in Deep Carious Molars: a Randomized Controlled Trial
Lead Sponsor:
Cairo University
Conditions:
Dental Caries
Pulp Caping
Eligibility:
All Genders
20-40 years
Phase:
PHASE2
Brief Summary
The aim of this study is the clinical and radiographic evaluation of (Platelet-Rich Fibrin (PRF) versus Mineral Trioxide Aggregate (MTA) in indirect pulp capping when used with deep carious molars ove...
Detailed Description
-PICOTS : P: Asymptomatic deep carious molars. I: Indirect pulp capping using PRF. C: Indirect pulp capping using MTA. O: Outcome name Measuring device Measuring unit Primary outcome: clinical fin...
Eligibility Criteria
Inclusion
- o Patients with asymptomatic deep carious molars.
- Patients with clinically and radiographically confirmed deep carious lesions that do not exhibit spontaneous pain.
- Permanent molars only.
- Teeth with intact or minimally restored occlusal surfaces (i.e., no extensive restorations or fractures).
- No history of previous endodontic treatment or direct pulp capping on the study tooth.
- No signs of periapical pathology based on radiographic evaluation.
- Patients willing to participate and follow up for 12 months.
- Patients who agree to return for scheduled follow-ups at 3, 6, and 12 months.
Exclusion
- o Patients with systemic conditions affecting bone or tissue healing (e.g., uncontrolled diabetes, osteoporosis, immunosuppressed conditions).
- Pregnant or lactating women (if applicable to your study).
- Teeth with pulp exposure or necrotic pulp.
- Presence of symptomatic irreversible pulpitis (e.g., spontaneous pain, lingering pain).
- Periapical pathology or internal/external resorption detected radiographically.
- Severely broken down or non-restorable teeth.
- Calcified root canals or excessive sclerosis that could affect pulp testing reliability.
- Any pre-existing root canal treatment on the selected tooth.
- Patients who have undergone recent fluoride treatment, pulpotomy, or other pulp therapies in the past 6 months.
- Patients using medications affecting bone and tissue regeneration (e.g., bisphosphonates, corticosteroids).
- Patients unwilling or unable to commit to the 12-month follow-up schedule.
- Patients with poor oral hygiene or high caries risk that could compromise treatment outcomes.
Key Trial Info
Start Date :
June 1 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
September 1 2026
Estimated Enrollment :
50 Patients enrolled
Trial Details
Trial ID
NCT06889363
Start Date
June 1 2025
End Date
September 1 2026
Last Update
March 21 2025
Active Locations (1)
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1
Cairo University
Giza, القاهرة - Cairo Governorate, Egypt, 11585