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

NCT04488679 | Completed

• 1 other identifier: 111261
• Study Type: interventional
• Target: 108
• Locations: 1 country
• Sites: 1

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

Keywords

platelet Rich fibrin , MTA

Outcome Measures

Primary Outcomes (8)

• 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 Outcomes (1)

• radiographic assessment of incidence of regenerative dentin (dentin bridge)

  1 year

Study Arms (2)

PRF along with MTA

EXPERIMENTAL

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

Other: direct pulp capping

MTA direct pulp capping

ACTIVE COMPARATOR

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

Interventions

direct pulp capping 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

Also known as: vital pulp therapy

MTA direct pulp capping; PRF along with MTA

Eligibility Criteria

• Age: 15 Years - 40 Years
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Rahma Ahmed Ibrahem Hafiz: lead

Study Sites (1)

Cairo University

Cairo, Manial, 02, Egypt

Location

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: assisstant lecturer- faculty of dentistry- beni suef university

Study Record Dates

• First Submitted: July 18, 2020
• First Posted: July 28, 2020
• Study Start: September 5, 2022
• Primary Completion: August 20, 2024
• Study Completion: August 20, 2024
• Last Updated: September 19, 2024

Record last verified: 2024-09

Locations

EG (1)