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

Study Overview
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Brief Summary
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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

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

Conditions
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Direct Pulp Capping

Intervention / Treatment
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* Other: direct pulp capping


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 15 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: PRF along with MTA<br>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<br>* 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<br>* Other names: vital pulp therapy;|
| Active Comparator: MTA direct pulp capping<br>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<br>* 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<br>* Other names: vital pulp therapy;|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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platelet Rich fibrin , MTA