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

Not Applicable

• Conditions: 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

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