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

R

Rahma Ahmed Ibrahem Hafiz

Status

Completed

Conditions

Direct Pulp Capping

Treatments

Other: direct pulp capping

Study type

Interventional

Funder types

Other

Identifiers

Details and patient eligibility

About

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

Enrollment

108 patients

Sex

All

Ages

15 to 40 years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Triple Blind

108 participants in 2 patient groups

PRF along with MTA
Experimental group
Description:
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
Treatment:
Other: direct pulp capping
MTA direct pulp capping
Active Comparator group
Description:
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
Treatment:
Other: direct pulp capping

Trial contacts and locations

1

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Central trial contact

Rahma Ah Abuhashema, MSc

Data sourced from clinicaltrials.gov

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