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

Cairo University (CU)

Status and phase: Not yet enrolling; Phase 2

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

Treatments: Biological: PRF; Drug: MTA

Study type: Interventional

Funder types: Other

Identifiers

NCT06889363

SALMA.MOHAMED.MONIR.PhD

Details and patient eligibility

About

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.

Full 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?

Enrollment: 50 estimated patients

Sex: All

Ages: 20 to 40 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

---

50 participants in 2 patient groups

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

Experimental group

Description:

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

Treatment:

Biological: PRF

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

Active Comparator group

Description:

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

Treatment:

Drug: MTA