<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/NCT03833557</url>
  </required_header>
  <id_info>
    <org_study_id>181053</org_study_id>
    <nct_id>NCT03833557</nct_id>
  </id_info>
  <brief_title>Success Rate of Three Capping Materials</brief_title>
  <official_title>Success Rate of Three Capping Materials Used in Pulpotomy of Primary Molars: A Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      A randomized clinical trial was carried out on 72 second primary molars indicated for&#xD;
      pulpotomy divided into three equal groups (n=24) . First group received Nanohydroxyapatite as&#xD;
      a pulpotomy agent , second group received Mineral Trioxide Aggregate ( MTA) &amp; the third&#xD;
      received Formocresol pulpotomy. All pulpotomized teeth were finally restored with stainless&#xD;
      steel crowns. Subjects were monitored clinically and radiographically at one, three , six &amp;&#xD;
      12 months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study population included four to eight years old healthy and cooperative patients who&#xD;
      presented at the Pediatric Dental Clinic, Faculty of Dentistry, Cairo University with&#xD;
      mandibular second primary molars indicated for pulpotomy which met specific inclusion and&#xD;
      exclusion criteria. Written consent was obtained from the parent/guardian after explaining&#xD;
      the full details of the treatment procedure.&#xD;
&#xD;
      Procedures:&#xD;
&#xD;
      Preoperative periapical radiograph using periapical film size two Speed D Film , was taken&#xD;
      for the molars considered for treatment. Radiographs should be of proper film density and&#xD;
      contrast for proper radiographic diagnosis.&#xD;
&#xD;
      The pulpotomy procedure was performed by the same operator. Local anesthesia was induced and&#xD;
      rubber dam isolation was performed, followed by caries removal and deroofing of the pulp&#xD;
      chamber using a #330 high-speed carbide bur mounted in a water-cooled high speed turbine. The&#xD;
      coronal pulp tissue was amputated using a sterile sharp spoon excavator. The pulp chamber was&#xD;
      irrigated with physiologic saline. Pulp homeostasis was achieved using a sterile wet cotton&#xD;
      pellet applied for two to three min.&#xD;
&#xD;
      In Group 1:&#xD;
&#xD;
      Following the manufacturer's instructions, Nanohydroxyapatite was mixed with distilled water&#xD;
      to homogeneous consistency then introduced into the pulp chamber and condensed properly&#xD;
      against the pulp orifices.&#xD;
&#xD;
      In Group 2:&#xD;
&#xD;
      The MTA powder was mixed with sterile water in a 3:1 powder/water ratio according to the&#xD;
      manufacturer's instructions to obtain a thick creamy paste, then placed on the floor of the&#xD;
      pulp chamber using a messing gun and compacted against the pulp orifices with a condenser&#xD;
      over a moist cotton pellet.&#xD;
&#xD;
      Group 3:&#xD;
&#xD;
      A cotton pellet with formocresol was placed on the pulp stumps then removed and ZO/E dressing&#xD;
      was condensed against the pulp stumps.&#xD;
&#xD;
      All Molars were finally restored with stainless steel crowns cemented with GI cement . An&#xD;
      immediate postoperative radiograph using periapical film size two was taken.&#xD;
&#xD;
      Clinical and radiographic evaluation:&#xD;
&#xD;
      All treated patients were followed up at one, three , six &amp; 12 months after the pulpotomy.&#xD;
&#xD;
      The pulpotomized teeth were judged as clinically successful if they met the following&#xD;
      criteria: Absence of sensitivity, pain, tenderness to percussion, abscess, fistula or tooth&#xD;
      mobility. Radiographic success was defined if there were normal periodontal ligament space,&#xD;
      absence of furcation or periapical radiolucency, absence of internal or external root&#xD;
      resorption&#xD;
&#xD;
      Statistical analysis:&#xD;
&#xD;
      Data were collected, revised for completeness and logical consistency, tabulated, and&#xD;
      statistically analyzed.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">May 5, 2017</start_date>
  <completion_date type="Actual">January 14, 2019</completion_date>
  <primary_completion_date type="Actual">January 10, 2019</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 (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Clinical success rate</measure>
    <time_frame>12 Month</time_frame>
    <description>abscence of all clinical signs and symptoms of failure</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Radiographic success rate</measure>
    <time_frame>12 Month</time_frame>
    <description>Absence of any radiographic signs of failure</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">54</enrollment>
  <condition>Caries</condition>
  <arm_group>
    <arm_group_label>Nanohydroxyapatite Pulpotomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Biphasic calcium phosphate. Straumann BoneCeramic Regenerative Pulpotomy of 24 mandibular second primary molars using Nanohydroxyapatite&#xD;
In Group 1: 24 mandibular second primary molars Caries removal and deroofing of pulp chamber Following the manufacturer's instructions, Nanohydroxyapatite was mixed with distilled water to homogeneous consistency then introduced into the pulp chamber and condensed properly against the pulp orifices.&#xD;
All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken.&#xD;
Clinical and radiographic evaluation: All treated patients were followed up at one, three , six &amp; 12 months after the pulpotomy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MTA Pulpotomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Angelus Grey MTA , Regenerative Pulpotomy Pulpotomy of 24 mandibular second primary molars using MTA Caries removal and deroofing of pulp chamber The MTA powder was mixed with sterile water in a 3:1 powder/water ratio according to the manufacturer's instructions to obtain a thick creamy paste, then placed on the floor of the pulp chamber using a messing gun and compacted against the pulp orifices with a condenser over a moist cotton pellet.&#xD;
All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken.&#xD;
Clinical and radiographic evaluation at one, three ,six &amp; 12 months after pulpotomy.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Formocresl Pulpotomy</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Buckley' s Formocresol , Fixation pulpotomy Pulpotomy of 24 mandibular second primary molars using Formocresol Caries removal and deroofing of pulp chamber&#xD;
A cotton pellet with formocresol was placed on the pulp stumps then removed and ZO/E dressing was condensed against the pulp stumps.&#xD;
All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken.&#xD;
Clinical and radiographic evaluation: All treated patients were followed up at one, three , six &amp; 12 months after the pulpotomy for clinical and radiographic evaluation. Independently, two examiners evaluated the teeth clinically and radiographically.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Nanohydroxyapatite Pulpotomy</intervention_name>
    <description>Biphasic calcium phosphate 500-1000 Um Straumann BoneCeramic</description>
    <arm_group_label>Nanohydroxyapatite Pulpotomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MTA pulpotomy</intervention_name>
    <description>Angleus grey MTA</description>
    <arm_group_label>MTA Pulpotomy</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Formocresol Pulpotomy</intervention_name>
    <description>Buckley's Fromocresol. diluted full strength foromocresol</description>
    <arm_group_label>Formocresl Pulpotomy</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  • Absence of tenderness to percussion.&#xD;
&#xD;
               -  Absence of physiologic or pathologic tooth mobility.&#xD;
&#xD;
               -  No clinical evidence of pulpal inflammation or degeneration, such as history of&#xD;
                  swelling or presence of sinus tract.&#xD;
&#xD;
               -  Restorable teeth.&#xD;
&#xD;
               -  Absence of radiographic evidence of internal or external root resorption, pulpal&#xD;
                  calcification, or osseous disease (periapical or furcation infection&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  • Evidence of necrosis after access cavity preparation.&#xD;
&#xD;
               -  Hemostasis could not be achieved within three min after direct contact with a wet&#xD;
                  cotton pellet, prior to material placement.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>8 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Randa Youssef</name>
      <address>
        <city>Giza</city>
        <zip>+202</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>April 2020</verification_date>
  <study_first_submitted>January 30, 2019</study_first_submitted>
  <study_first_submitted_qc>February 5, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">February 7, 2019</study_first_posted>
  <last_update_submitted>April 2, 2020</last_update_submitted>
  <last_update_submitted_qc>April 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">April 6, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Randa Youssef Abd Al Gawad</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Formocresol</keyword>
  <keyword>MTA</keyword>
  <keyword>Nanohydroxyapatite</keyword>
  <keyword>Pulpotomy</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Study design and procedures</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
    <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
  </patient_data>
  <study_docs>
    <study_doc>
      <doc_type>Individual Participant Data Set</doc_type>
      <doc_url>http://scholar.cu.edu.eg</doc_url>
    </study_doc>
  </study_docs>
  <!-- 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/NCT03833557
org study id: 181053
nct id: NCT03833557
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A randomized clinical trial was carried out on 72 second primary molars indicated for
      pulpotomy divided into three equal groups (n=24) . First group received Nanohydroxyapatite as
      a pulpotomy agent , second group received Mineral Trioxide Aggregate ( MTA) & the third
      received Formocresol pulpotomy. All pulpotomized teeth were finally restored with stainless
      steel crowns. Subjects were monitored clinically and radiographically at one, three , six &
      12 months.
The study population included four to eight years old healthy and cooperative patients who
      presented at the Pediatric Dental Clinic, Faculty of Dentistry, Cairo University with
      mandibular second primary molars indicated for pulpotomy which met specific inclusion and
      exclusion criteria. Written consent was obtained from the parent/guardian after explaining
      the full details of the treatment procedure.

      Procedures:

      Preoperative periapical radiograph using periapical film size two Speed D Film , was taken
      for the molars considered for treatment. Radiographs should be of proper film density and
      contrast for proper radiographic diagnosis.

      The pulpotomy procedure was performed by the same operator. Local anesthesia was induced and
      rubber dam isolation was performed, followed by caries removal and deroofing of the pulp
      chamber using a #330 high-speed carbide bur mounted in a water-cooled high speed turbine. The
      coronal pulp tissue was amputated using a sterile sharp spoon excavator. The pulp chamber was
      irrigated with physiologic saline. Pulp homeostasis was achieved using a sterile wet cotton
      pellet applied for two to three min.

      In Group 1:

      Following the manufacturer's instructions, Nanohydroxyapatite was mixed with distilled water
      to homogeneous consistency then introduced into the pulp chamber and condensed properly
      against the pulp orifices.

      In Group 2:

      The MTA powder was mixed with sterile water in a 3:1 powder/water ratio according to the
      manufacturer's instructions to obtain a thick creamy paste, then placed on the floor of the
      pulp chamber using a messing gun and compacted against the pulp orifices with a condenser
      over a moist cotton pellet.

      Group 3:

      A cotton pellet with formocresol was placed on the pulp stumps then removed and ZO/E dressing
      was condensed against the pulp stumps.

      All Molars were finally restored with stainless steel crowns cemented with GI cement . An
      immediate postoperative radiograph using periapical film size two was taken.

      Clinical and radiographic evaluation:

      All treated patients were followed up at one, three , six & 12 months after the pulpotomy.

      The pulpotomized teeth were judged as clinically successful if they met the following
      criteria: Absence of sensitivity, pain, tenderness to percussion, abscess, fistula or tooth
      mobility. Radiographic success was defined if there were normal periodontal ligament space,
      absence of furcation or periapical radiolucency, absence of internal or external root
      resorption

      Statistical analysis:

      Data were collected, revised for completeness and logical consistency, tabulated, and
      statistically analyzed.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Care Provider)
measure: Clinical success rate
time frame: 12 Month
description: abscence of all clinical signs and symptoms of failure
measure: Radiographic success rate
time frame: 12 Month
description: Absence of any radiographic signs of failure
arm group label: Nanohydroxyapatite Pulpotomy
arm group type: Active Comparator
description: Biphasic calcium phosphate. Straumann BoneCeramic Regenerative Pulpotomy of 24 mandibular second primary molars using Nanohydroxyapatite
In Group 1: 24 mandibular second primary molars Caries removal and deroofing of pulp chamber Following the manufacturer's instructions, Nanohydroxyapatite was mixed with distilled water to homogeneous consistency then introduced into the pulp chamber and condensed properly against the pulp orifices.
All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken.
Clinical and radiographic evaluation: All treated patients were followed up at one, three , six & 12 months after the pulpotomy
arm group label: MTA Pulpotomy
arm group type: Active Comparator
description: Angelus Grey MTA , Regenerative Pulpotomy Pulpotomy of 24 mandibular second primary molars using MTA Caries removal and deroofing of pulp chamber The MTA powder was mixed with sterile water in a 3:1 powder/water ratio according to the manufacturer's instructions to obtain a thick creamy paste, then placed on the floor of the pulp chamber using a messing gun and compacted against the pulp orifices with a condenser over a moist cotton pellet.
All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken.
Clinical and radiographic evaluation at one, three ,six & 12 months after pulpotomy.
arm group label: Formocresl Pulpotomy
arm group type: Active Comparator
description: Buckley' s Formocresol , Fixation pulpotomy Pulpotomy of 24 mandibular second primary molars using Formocresol Caries removal and deroofing of pulp chamber
A cotton pellet with formocresol was placed on the pulp stumps then removed and ZO/E dressing was condensed against the pulp stumps.
All Molars were finally restored with stainless steel crowns cemented with GI cement . An immediate postoperative radiograph using periapical film size two was taken.
Clinical and radiographic evaluation: All treated patients were followed up at one, three , six & 12 months after the pulpotomy for clinical and radiographic evaluation. Independently, two examiners evaluated the teeth clinically and radiographically.
intervention type: Procedure
intervention name: Nanohydroxyapatite Pulpotomy
description: Biphasic calcium phosphate 500-1000 Um Straumann BoneCeramic
arm group label: Nanohydroxyapatite Pulpotomy
intervention type: Procedure
intervention name: MTA pulpotomy
description: Angleus grey MTA
arm group label: MTA Pulpotomy
intervention type: Procedure
intervention name: Formocresol Pulpotomy
description: Buckley's Fromocresol. diluted full strength foromocresol
arm group label: Formocresl Pulpotomy
criteria: 
gender: All
minimum age: 4 Years
maximum age: 8 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Randa Youssef Abd Al Gawad
investigator title: Principal investigator
sharing ipd: Yes
ipd description: Study design and procedures
ipd info type: Study Protocol
ipd info type: Statistical Analysis Plan (SAP)
ipd info type: Informed Consent Form (ICF)
study doc: 