<clinical_study>
  <!-- This xml conforms to an XML Schema at:
    https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
  <required_header>
    <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
    <link_text>Link to the current ClinicalTrials.gov record.</link_text>
    <url>https://clinicaltrials.gov/ct2/show/NCT04488679</url>
  </required_header>
  <id_info>
    <org_study_id>111261</org_study_id>
    <nct_id>NCT04488679</nct_id>
  </id_info>
  <brief_title>Clinical and Radiographic Assessment of Platelet Rich Fibrin and Mineral Trioxide Aggregate as Pulp Capping Biomaterials</brief_title>
  <official_title>Clinical and Radiographic Assessment of Platelet Rich Fibrin and Mineral Trioxide Aggregate as Pulp Capping Biomaterials: A Randomized Control Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Rahma Ahmed Ibrahem Hafiz</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      eligible carious teeth with exposed pulp by the undergraduate students will be randomly&#xD;
      divided into two groups to be treated with direct pulp capping (A), where (A1) represents the&#xD;
      comparator group where teeth will be treated with direct application of MTA over the exposed&#xD;
      pulp, (A2) represents teeth to be treated with the application of PRF directly over exposed&#xD;
      pulp followed by MTA application. clinical and radiographic assessment of tooth vitality,&#xD;
      history of pain, pain on percussion, and dentin bridge formation will be performed at&#xD;
      baseline, 6 months, and 1 year&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Not yet recruiting</overall_status>
  <start_date type="Anticipated">September 2022</start_date>
  <completion_date type="Anticipated">October 2023</completion_date>
  <primary_completion_date type="Anticipated">September 2023</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Care Provider, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical success rate</measure>
    <time_frame>6 months</time_frame>
    <description>pulp vitality by thermal pulp testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>clinical success rate</measure>
    <time_frame>6 months</time_frame>
    <description>history of pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>clinical success rate</measure>
    <time_frame>6 months</time_frame>
    <description>pain on percussion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>clinical success rate</measure>
    <time_frame>6 months</time_frame>
    <description>radiographic signs of pulp necrosis and apical periodontitis</description>
  </primary_outcome>
  <primary_outcome>
    <measure>clinical success rate</measure>
    <time_frame>1 year</time_frame>
    <description>pulp vitality by thermal pulp testing</description>
  </primary_outcome>
  <primary_outcome>
    <measure>clinical success rate</measure>
    <time_frame>1 year</time_frame>
    <description>history of pain</description>
  </primary_outcome>
  <primary_outcome>
    <measure>clinical success rate</measure>
    <time_frame>1 year</time_frame>
    <description>no pain on percussion</description>
  </primary_outcome>
  <primary_outcome>
    <measure>clinical success rate</measure>
    <time_frame>1 year</time_frame>
    <description>radiographic signs of pulp necrosis and apical periodontitis</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>radiographic assessment of regerenerative dentin formation(dentin bridge)</measure>
    <time_frame>6 months</time_frame>
    <description>assessment of dentin bridge by digital radiography (digrora software)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>radiographic assessment of incidence of regenerative dentin (dentin bridge)</measure>
    <time_frame>1 year</time_frame>
    <description>assessment of dentin bridge by digital radiography (digrora software)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Direct Pulp Capping</condition>
  <arm_group>
    <arm_group_label>PRF along with MTA</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <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 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</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MTA direct pulp capping</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <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</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>direct pulp capping</intervention_name>
    <description>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</description>
    <arm_group_label>MTA direct pulp capping</arm_group_label>
    <arm_group_label>PRF along with MTA</arm_group_label>
    <other_name>vital pulp therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patient aged 15:40 years old.&#xD;
&#xD;
          -  Patients exhibiting pulp exposure (carious, traumatic, or mechanical) during&#xD;
             management of active carious lesions with less than 2 mm of carious exposure.&#xD;
&#xD;
          -  Signs and symptoms indicative of pulp vitality, i.e. a positive response to thermal&#xD;
             stimulation during a cold test.&#xD;
&#xD;
          -  periapical radiograph showing closed apex and normal periapex&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Teeth with spontaneous pain or sensitivity to percussion (signs of irreversible&#xD;
             pulpitis).&#xD;
&#xD;
          -  Teeth with periodontal lesions, internal or external root resorption, calcified&#xD;
             canals, mobility of tooth, sinus opening, or abscessed tooth.&#xD;
&#xD;
          -  Non restorable tooth.&#xD;
&#xD;
          -  Radiographic examination revealed, interrupted or broken lamina dura, widened&#xD;
             periodontal ligament space, periapical radiolucency.&#xD;
&#xD;
          -  Pulp bleeding that could not be controlled within 10 minutes using 2.5% sodium&#xD;
             hypochlorite&#xD;
&#xD;
          -  Immune-compromised patients or with systemic medical disorders.&#xD;
&#xD;
          -  pregnant females&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <gender_based>Yes</gender_based>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Rahma Ah Abuhashema, MSc</last_name>
    <phone>01003674989</phone>
    <phone_ext>002</phone_ext>
    <email>rahma.ibrahem@dentistry.cu.edu.eg</email>
  </overall_contact>
  <verification_date>August 2022</verification_date>
  <study_first_submitted>July 18, 2020</study_first_submitted>
  <study_first_submitted_qc>July 23, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 28, 2020</study_first_posted>
  <last_update_submitted>August 8, 2022</last_update_submitted>
  <last_update_submitted_qc>August 8, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">August 10, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Rahma Ahmed Ibrahem Hafiz</investigator_full_name>
    <investigator_title>assisstant lecturer- faculty of dentistry- beni suef university</investigator_title>
  </responsible_party>
  <keyword>platelet Rich fibrin , MTA</keyword>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04488679
org study id: 111261
nct id: NCT04488679
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
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
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Care Provider, Outcomes Assessor)
measure: clinical success rate
time frame: 6 months
description: pulp vitality by thermal pulp testing
measure: clinical success rate
time frame: 6 months
description: history of pain
measure: clinical success rate
time frame: 6 months
description: pain on percussion
measure: clinical success rate
time frame: 6 months
description: radiographic signs of pulp necrosis and apical periodontitis
measure: clinical success rate
time frame: 1 year
description: pulp vitality by thermal pulp testing
measure: clinical success rate
time frame: 1 year
description: history of pain
measure: clinical success rate
time frame: 1 year
description: no pain on percussion
measure: clinical success rate
time frame: 1 year
description: radiographic signs of pulp necrosis and apical periodontitis
measure: radiographic assessment of regerenerative dentin formation(dentin bridge)
time frame: 6 months
description: assessment of dentin bridge by digital radiography (digrora software)
measure: radiographic assessment of incidence of regenerative dentin (dentin bridge)
time frame: 1 year
description: assessment of dentin bridge by digital radiography (digrora software)
arm group label: PRF along with MTA
arm group type: Experimental
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 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
arm group label: MTA direct pulp capping
arm group type: Active Comparator
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
intervention type: Other
intervention name: direct pulp capping
description: 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
arm group label: MTA direct pulp capping
arm group label: PRF along with MTA
other name: vital pulp therapy
criteria: 
gender: All
gender based: Yes
minimum age: 15 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Rahma Ah Abuhashema, MSc
phone: 01003674989
phone ext: 002
email: rahma.ibrahem@dentistry.cu.edu.eg
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Rahma Ahmed Ibrahem Hafiz
investigator title: assisstant lecturer- faculty of dentistry- beni suef university