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

NCT ID: NCT04488679

Last Updated: 2024-09-19

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 108 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-09-05
• Study Completion Date: 2024-08-20

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

Conditions

Direct Pulp Capping

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

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 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

Group Type: EXPERIMENTAL

direct pulp capping

Intervention Type: OTHER

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

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

Group Type: ACTIVE_COMPARATOR

direct pulp capping

Intervention Type: OTHER

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

Interventions

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

Intervention Type: OTHER

Other Intervention Names

vital pulp therapy

Eligibility Criteria

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

• Minimum Eligible Age: 15 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Rahma Ahmed Ibrahem Hafiz

OTHER

Sponsor Role: lead

Responsible Party

Rahma Ahmed Ibrahem Hafiz

assisstant lecturer- faculty of dentistry- beni suef university

Responsibility Role: SPONSOR_INVESTIGATOR

Locations

Cairo University

Cairo, Manial, Egypt

Countries

Egypt

Other Identifiers

111261

Identifier Type: -

Identifier Source: org_study_id