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Not yet recruiting NCT06889363

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 II Interventional Dental Caries Pulp Caping Indirect Pulp Treatment Indirect Pulp Cap

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: MTA, PRF.
Who it may be relevant to
Registry conditions: Dental Caries, Pulp Caping, Indirect Pulp Treatment, Indirect Pulp Cap. Basic parameters: 20 years — 40 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Egypt
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

Unsure about the terms? Read our patient guide →

Overview

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

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

Primary outcome measures

  • Pulp sensibility using cold test [Time frame: baseline, 3 , 6, 12 months]
Secondary outcome measures (1)
  • Radiographic finding [Time frame: baseline, 3 , 6, 12 months]

Eligibility criteria

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.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Single blind
Primary purpose
Treatment

Study locations

Egypt · 1 center
  • Cairo University — Giza

Identifiers

NCT: NCT06889363 · SALMA.MOHAMED.MONIR.PhD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗