Clinical and Radiographic Assessment of Platelet Rich Fibrin and Mineral Trioxide Aggregate as Pulp Capping Biomaterials

Clinical and Radiographic Assessment of Platelet Rich Fibrin and Mineral Trioxide Aggregate as Pulp Capping Biomaterials: A Randomized Control Trial

eligible carious teeth with exposed pulp by the undergraduate students will be randomly divided into two groups to be treated with direct pulp capping (A), where (A1) represents the comparator group where teeth will be treated with direct application of MTA over the exposed pulp, (A2) represents teeth to be treated with the application of PRF directly over exposed pulp followed by MTA application. clinical and radiographic assessment of tooth vitality, history of pain, pain on percussion, and dentin bridge formation will be performed at baseline, 6 months, and 1 year

Study Overview

• Status: Not yet recruiting
• Conditions: Direct Pulp Capping
• Intervention / Treatment: Other: direct pulp capping

• Study Type: Interventional
• Enrollment (Anticipated): 66
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Rahma Ah Abuhashema, MSc; Phone Number: 002 01003674989; Email: rahma.ibrahem@dentistry.cu.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 15 years to 35 years (Child, Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• Patient aged 15:40 years old.
• Patients exhibiting pulp exposure (carious, traumatic, or mechanical) during management of active carious lesions with less than 2 mm of carious exposure.
• Signs and symptoms indicative of pulp vitality, i.e. a positive response to thermal stimulation during a cold test.
• periapical radiograph showing closed apex and normal periapex

Exclusion Criteria:

• Teeth with spontaneous pain or sensitivity to percussion (signs of irreversible pulpitis).
• Teeth with periodontal lesions, internal or external root resorption, calcified canals, mobility of tooth, sinus opening, or abscessed tooth.
• Non restorable tooth.
• Radiographic examination revealed, interrupted or broken lamina dura, widened periodontal ligament space, periapical radiolucency.
• Pulp bleeding that could not be controlled within 10 minutes using 2.5% sodium hypochlorite
• Immune-compromised patients or with systemic medical disorders.
• pregnant females

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: PRF along with MTA; 5 ml of the participant blood will be drawn into 10 ml test tubes without an anticoagulant and centrifuged immediately .centrifugation will be done using a tabletop centrifuge for 12 min at 2700 rounds per minute. The resultant product will exhibit three layers. platelet-poor plasma at the surface, PRF clot in the middle, and red blood cells at the bottom. Sterile tweezers inserted into a test tube to retrieve the PRF clot. The prepared fibrin membrane will be gently packed over the pulp	Other: direct pulp capping; teeth with exposed pulp during caries removal will be capped either with PRF followed by mta or mta alone directly on exposed pulp, in both groups restoration will be placed over mta; Other Names: vital pulp therapy
Active Comparator: MTA direct pulp capping; MTA is primarily calcium oxide in the form of tricalcium silicate, dicalcium silicate and tricalcium aluminate. Bismuth oxide is added for radiopacity, MTA is considered a silicate cement rather than an oxide mixture, a so its biocompatibility is due to its reaction products. MTA elevates the expression of transcription factors, induces dentin bridge formation, possesses biocompatibility9, and sustains a high pH for a longer duration and a close physiochemical seal with dentin that forms an insoluble barrier to prevent microleakag	Other: direct pulp capping; teeth with exposed pulp during caries removal will be capped either with PRF followed by mta or mta alone directly on exposed pulp, in both groups restoration will be placed over mta; Other Names: vital pulp therapy

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
clinical success rate	pulp vitality by thermal pulp testing	6 months
clinical success rate	history of pain	6 months
clinical success rate	pain on percussion	6 months
clinical success rate	radiographic signs of pulp necrosis and apical periodontitis	6 months
clinical success rate	pulp vitality by thermal pulp testing	1 year
clinical success rate	history of pain	1 year
clinical success rate	no pain on percussion	1 year
clinical success rate	radiographic signs of pulp necrosis and apical periodontitis	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
radiographic assessment of regerenerative dentin formation(dentin bridge)	assessment of dentin bridge by digital radiography (digrora software)	6 months
radiographic assessment of incidence of regenerative dentin (dentin bridge)	assessment of dentin bridge by digital radiography (digrora software)	1 year

Collaborators and Investigators

• Sponsor: Rahma Ahmed Ibrahem Hafiz

Study record dates

Study Major Dates

• Study Start (Anticipated): September 1, 2022
• Primary Completion (Anticipated): September 1, 2023
• Study Completion (Anticipated): October 1, 2023

Study Registration Dates

• First Submitted: July 18, 2020
• First Submitted That Met QC Criteria: July 23, 2020
• First Posted (Actual): July 28, 2020

Study Record Updates

• Last Update Posted (Actual): August 10, 2022
• Last Update Submitted That Met QC Criteria: August 8, 2022
• Last Verified: August 1, 2022

More Information

Terms related to this study

• Keywords: platelet Rich fibrin , MTA
• Other Study ID Numbers: 111261

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No