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Completed

NCT Number: NCT04488679

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

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

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Key information

Conditions

Age range

15 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Cairo University

Cairo, Manial, 02, Egypt

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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

Other names: vital pulp therapy

Primary outcomes

  1. clinical success rate

    Time frame: 6 months

    pulp vitality by thermal pulp testing

  2. clinical success rate

    Time frame: 6 months

    history of pain

  3. clinical success rate

    Time frame: 6 months

    pain on percussion

  4. clinical success rate

    Time frame: 6 months

    radiographic signs of pulp necrosis and apical periodontitis

  5. clinical success rate

    Time frame: 1 year

    pulp vitality by thermal pulp testing

  6. clinical success rate

    Time frame: 1 year

    history of pain

  7. clinical success rate

    Time frame: 1 year

    no pain on percussion

  8. clinical success rate

    Time frame: 1 year

    radiographic signs of pulp necrosis and apical periodontitis

Secondary outcomes

  1. radiographic assessment of incidence of regenerative dentin (dentin bridge)

    Time frame: 1 year

    assessment of dentin bridge by digital radiography

Sponsors and collaborators

Lead sponsor

Rahma Ahmed Ibrahem Hafiz

Other

Registry information

Official study title

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

Important dates

Study start
2022
Primary completion
2024
Study completion
2024
First posted
Jul 28, 2020
Registry last updated
Sep 19, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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