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

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

Status
Not yet recruiting
Phases
Phase 2
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT06889363
Enrollment
50
Registered
2025-03-21
Start date
2025-06-30
Completion date
2026-09-30
Last updated
2025-03-21

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

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

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?

Interventions

DRUGMTA

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

BIOLOGICALPRF

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

Sponsors

Cairo University
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Outcomes Assessor)

Masking description

statistician

Eligibility

Sex/Gender
ALL
Age
20 Years to 40 Years
Healthy volunteers
No

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.

Design outcomes

Primary

MeasureTime frameDescription
Pulp sensibility using cold testbaseline, 3 , 6, 12 monthsclinical finding of the investigated tooth measured with binary (yes or no)

Secondary

MeasureTime frameDescription
Radiographic findingbaseline, 3 , 6, 12 monthsDigital Periapical using paralleling technique (Dentin bridge measurement in mm using digital radiographic ruler)

Countries

Egypt

Contacts

Primary Contactsalma mohamed monir, MSc Cairo university
salma.elaraby@dentistry.cu.edu.eg+201223035036

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026