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

Обзор

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.

Подробное описание

-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?

Вмешательства

• Препарат MTA
  The indirect pulp capping will be applied using MTA using an MTA carrier, then glass ionomer will be applied, then composite restoration above
• Биопрепарат PRF
  The indirect pulp capping will be applied using PRF on a membrane, then glass ionomer will be applied , then composite restoration above

Первичные конечные точки

• Pulp sensibility using cold test [Срок оценки: baseline, 3 , 6, 12 months]

Вторичные конечные точки (1)

• Radiographic finding [Срок оценки: baseline, 3 , 6, 12 months]

Критерии участия

Критерии включения

• 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.

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Простое слепое

Основная цель

Лечение

Центры проведения

Египет · 1 центр

• Cairo University — Giza

Идентификаторы

NCT: NCT06889363 · SALMA.MOHAMED.MONIR.PhD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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