Clinical and Radiographic Evaluation of Indirect Pulp Capping Using Platelet Rich Fibrin Versus Mineral Trioxide Aggregate in Deep Carious Molars: a Randomized Controlled Trial

Phase 2

Not yet recruiting

• Conditions: Dental Caries; Indirect Pulp Cap; Deep Carious Lesions; Molar Caries; Pulp Caping; Deep Carious Lesion; Indirect Pulp Treatment; Indirect Pulp Capping; Indirect Pulp Therapy; Carious Molars
• Interventions: Biological: PRF; Drug: MTA

• Registration Number: NCT06889363
• Lead Sponsor: Cairo University

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 over 1 year follow up.

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 findings : Pulp sensibility using cold test (Sharma A et al., 2020).

Secondary outcome:

Radiographic findings :Dentin bridge measurement in mm using digital radiographic ruler Digital Periapical using paralleling technique (Sharma A et al., 2020).

T:

T0: Baseline T1: 3 months T2: 6 months T3: 12 months S: Randomized clinical trial.

- Research question: Will PRF provide comparable clinical and radiographic outcomes to MTA in indirect pulp capping when used in deep carious molars?

Study Timeline

• Status Verified: 2025-03
• Study First Submitted: 2025-03-17
• Study First Submitted QC: 2025-03-17
• Last Update Submitted: 2025-03-17
• Study First Posted: 2025-03-21
• Last Update Posted: 2025-03-21
• Study Start: 2025-06
• Primary Completion: 2026-09
• Study Completion: 2026-09

Recruitment & Eligibility

• Status: NOT_YET_RECRUITING
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

• 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 Criteria

• 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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Deep carious molars, indirect pulp capping using PRF then GI base then composite restoration	PRF	Deep carious molars, indirect pulp capping using PRF then GI base then composite restoration
Deep carious molars, indirect pulp capping using MTA then GI base then composite restoration	MTA	Deep carious molars, indirect pulp capping using MTA then GI base then composite restoration

Primary Outcome Measures

Name	Time	Method
Pulp sensibility using cold test	baseline, 3 , 6, 12 months	clinical finding of the investigated tooth measured with binary (yes or no)

Secondary Outcome Measures

Name	Time	Method
Radiographic finding	baseline, 3 , 6, 12 months	Digital Periapical using paralleling technique (Dentin bridge measurement in mm using digital radiographic ruler)

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Giza, القاهرة - Cairo Governorate, Egypt