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

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.

Study Overview

• Status: Not yet recruiting
• Conditions: Dental Caries; Indirect Pulp Cap; Indirect Pulp Capping; Deep Carious Lesions; Indirect Pulp Treatment; Deep Carious Lesion; Pulp Caping; Carious Molars; Indirect Pulp Therapy; Molar Caries
• Intervention / Treatment: Biological: PRF; Drug: MTA

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 Type: Interventional
• Enrollment (Estimated): 50
• Phase: Phase 2

Contacts and Locations

• Study Contact: Name: salma mohamed monir, MSc Cairo university; Phone Number: +201223035036; Email: salma.elaraby@dentistry.cu.edu.eg

Study Locations

• Egypt
  • القاهرة - Cairo Governorate
    • Giza, القاهرة - Cairo Governorate, Egypt, 11585
      • Cairo University
      • Contact: Eman Ali Abouauf, Assistant Professor; Phone Number: +2001001785300; Email: e.abouauf@dentistry.cu.edu.eg
      • Contact: salma mohammed monir, MSc Cairo university

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: No

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: Deep carious molars, indirect pulp capping using PRF then GI base then composite restoration	Biological: PRF; The indirect pulp capping will be applied using PRF on a membrane, then glass ionomer will be applied , then composite restoration above; Other Names: platelet rich fibrin
Active Comparator: Deep carious molars, indirect pulp capping using MTA then GI base then composite restoration	Drug: MTA; The indirect pulp capping will be applied using MTA using an MTA carrier, then glass ionomer will be applied, then composite restoration above; Other Names: mineral trioxide aggregate

What is the study measuring?

Primary Outcome Measures

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

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Cairo University

Study record dates

Study Major Dates

• Study Start (Estimated): June 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026

Study Registration Dates

• First Submitted: March 17, 2025
• First Submitted That Met QC Criteria: March 17, 2025
• First Posted (Actual): March 25, 2025

Study Record Updates

• Last Update Posted (Actual): March 25, 2025
• Last Update Submitted That Met QC Criteria: March 17, 2025
• Last Verified: March 1, 2025

More Information

Terms related to this study

• Keywords: PRF; MTA; platelet rich fibrin; Deep carious lesion; Indirect pulp capping; Molar caries; carious molars
• Additional Relevant MeSH Terms: Stomatognathic Diseases; Tooth Diseases; Tooth Demineralization; Dental Caries
• Other Study ID Numbers: SALMA.MOHAMED.MONIR.PhD

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No