Clinical trial 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
Official title: Clinical and Radiographic Evaluation of Indirect Pulp Capping Using Platelet Rich Fibrin Versus Mineral Trioxide Aggregate in Deep Carious Molars: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: PHASE2
Conditions: Dental Caries
Pulp Caping
Indirect Pulp Treatment
Indirect Pulp Cap
Indirect Pulp Capping
Indirect Pulp Therapy
Deep Carious Lesion
Deep Carious Lesions
Molar Caries
Carious Molars
Keywords: Molar caries
MTA
PRF
Indirect pulp capping
Deep carious lesion
carious molars
platelet rich fibrin
Lead sponsor: Cairo University
Sponsor class: OTHER
First posted: 2025-03-21
Enrollment: 50
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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?

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.

Primary outcomes:
measure: Pulp sensibility using cold test
timeFrame: baseline, 3 , 6, 12 months
Secondary outcomes:
measure: Radiographic finding
timeFrame: baseline, 3 , 6, 12 months
Other outcomes:
Locations:
city: Giza
country: Egypt
facility: Cairo University
state: القاهرة - Cairo Governorate
Study officials:
References: