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

NCT06889363 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: SALMA.MOHAMED.MONIR.PhD
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Dental Caries; Pulp Caping; Indirect Pulp Treatment; Indirect Pulp Cap; Indirect Pulp Capping; Indirect Pulp Therapy; Deep Carious Lesion; Deep Carious Lesions; Molar Caries; Carious Molars

Keywords

Molar caries; MTA; PRF; Indirect pulp capping; Deep carious lesion; carious molars; platelet rich fibrin

Outcome Measures

Primary Outcomes (1)

• Pulp sensibility using cold test

  clinical finding of the investigated tooth measured with binary (yes or no)

  baseline, 3 , 6, 12 months

Secondary Outcomes (1)

• Radiographic finding

  baseline, 3 , 6, 12 months

Study Arms (2)

Deep carious molars, indirect pulp capping using PRF then GI base then composite restoration

EXPERIMENTAL

Deep carious molars, indirect pulp capping using PRF then GI base then composite restoration

Biological: PRF

Deep carious molars, indirect pulp capping using MTA then GI base then composite restoration

ACTIVE COMPARATOR

Deep carious molars, indirect pulp capping using MTA then GI base then composite restoration

Drug: MTA

Interventions

MTA DRUG

The indirect pulp capping will be applied using MTA using an MTA carrier, then glass ionomer will be applied, then composite restoration above

Also known as: mineral trioxide aggregate

Deep carious molars, indirect pulp capping using MTA then GI base then composite restoration

PRF BIOLOGICAL

The indirect pulp capping will be applied using PRF on a membrane, then glass ionomer will be applied , then composite restoration above

Also known as: platelet rich fibrin

Deep carious molars, indirect pulp capping using PRF then GI base then composite restoration

Eligibility Criteria

• Age: 20 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Giza, القاهرة - Cairo Governorate, 11585, Egypt

Location

MeSH Terms

Conditions

Dental Caries

Interventions

Pemetrexed; mineral trioxide aggregate

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Intervention Hierarchy (Ancestors)

Guanine; Hypoxanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Glutamates; Amino Acids, Acidic; Amino Acids; Amino Acids, Peptides, and Proteins; Amino Acids, Dicarboxylic

Central Study Contacts

salma mohamed monir, MSc Cairo university

CONTACT

+201223035036; salma.elaraby@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: statistician
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant lecturer

Study Record Dates

• First Submitted: March 17, 2025
• First Posted: March 21, 2025
• Study Start: June 1, 2025
• Primary Completion (Estimated): September 1, 2026
• Study Completion (Estimated): September 1, 2026
• Last Updated: March 21, 2025

Record last verified: 2025-03

Locations

EG (1)