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

Not Applicable

• Conditions: Direct Pulp Capping
• Interventions: Other: direct pulp capping

• Registration Number: NCT04488679
• Lead Sponsor: Rahma Ahmed Ibrahem Hafiz

Brief Summary

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

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2020-07-18
• Study First Submitted QC: 2020-07-23
• Study First Posted: 2020-07-28
• Status Verified: 2022-08
• Last Update Submitted: 2022-08-08
• Last Update Posted: 2022-08-10
• Study Start: 2022-09
• Primary Completion: 2023-09
• Study Completion: 2023-10

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 66

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
PRF along with MTA	direct pulp capping	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 10:12 min at 2700:3000 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
MTA direct pulp capping	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

Primary Outcome Measures

Name	Time	Method
clinical success rate	1 year	radiographic signs of pulp necrosis and apical periodontitis

Secondary Outcome Measures

Name	Time	Method
radiographic assessment of incidence of regenerative dentin (dentin bridge)	1 year	assessment of dentin bridge by digital radiography

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Cairo, Manial, Egypt