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NCT Number: 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

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.

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Key information

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Cairo University

Giza, القاهرة - Cairo Governorate, 11585, Egypt

Location contact

Eman Ali Abouauf, Assistant Professor

CONTACT

[email protected]

+2001001785300

salma mohammed monir, MSc Cairo university

CONTACT

About this study

-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?

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

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

Other names: mineral trioxide aggregate

PRF

Biological

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

Primary outcomes

  1. Pulp sensibility using cold test

    Time frame: baseline, 3 , 6, 12 months

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

Secondary outcomes

  1. Radiographic finding

    Time frame: baseline, 3 , 6, 12 months

    Digital Periapical using paralleling technique (Dentin bridge measurement in mm using digital radiographic ruler)

Study contacts

Contact information is provided by the study sponsor or research team.

salma mohamed monir, MSc Cairo university

CONTACT

[email protected]

+201223035036

Sponsors and collaborators

Lead sponsor

Cairo University

Other

Registry information

Important dates

Study start
2025
Primary completion
2026
Study completion
2026
First posted
Mar 21, 2025
Registry last updated
Mar 21, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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