<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/NCT03786302</url>
  </required_header>
  <id_info>
    <org_study_id>Bioglass in pulpotomized teeth</org_study_id>
    <nct_id>NCT03786302</nct_id>
  </id_info>
  <brief_title>Regenerative Ability of TAMP BG and BD in Pulpotomized Primary Teeth</brief_title>
  <official_title>Comparison of the Regenerative Ability of Tailored Amorphous Multiporous Bioglass and Biodentine in Pulpotomized Primary Teeth</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Nourhan M.Aly</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Alexandria University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Alexandria</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>
      The aim of this study was to assess clinically, radiographically, and histologically the&#xD;
      regenerative ability of Tailored Amorphous Mulioporous (TAMP-BG) bioglass in comparison to&#xD;
      Biodentine™ (BD) in pulpotomized primary teeth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The study was a parallel design, randomized controlled clinical trial It was conducted in the&#xD;
      out-patient clinic of the Pediatric Dentistry and Dental public health department after&#xD;
      obtaining the guardians consent. The sample size was calculated to be 35 teeth per group. The&#xD;
      teeth were randomly and equally assigned to either BD or TAMP-BG groups.The treatment&#xD;
      follow-up was scheduled at 1, 3, 6, 9 and 12 months. The study was terminated for ethical&#xD;
      considerations after showing significant clinical failure in the TAMP-BG group and after&#xD;
      performing interim analysis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Terminated</overall_status>
  <why_stopped>
    Failure rate was 100% in one arm of the study (the intervention)&#xD;
  </why_stopped>
  <start_date type="Actual">December 6, 2016</start_date>
  <completion_date type="Actual">October 20, 2018</completion_date>
  <primary_completion_date type="Actual">August 15, 2018</primary_completion_date>
  <phase>Phase 2</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>
    <intervention_model_description>Study group (assigned to TAMP bioglass), and Control group (assigned to Biodentine ™).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Care Provider, Outcomes Assessor)</masking>
    <masking_description>The operator will not be blinded to the treatment type. However, the participants, their care givers, the expert assessing the histologic and inflammatory changes and the statistician will be blinded to the treatment groups.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Absence of clinical signs of pulp degeneration.</measure>
    <time_frame>1 month postoperatively</time_frame>
    <description>Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Teeth with no clinical signs of pulp degeneration.</measure>
    <time_frame>3 months postoperatively</time_frame>
    <description>Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Teeth with no clinical signs of pulp degeneration.</measure>
    <time_frame>6 months postoperatively</time_frame>
    <description>Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Teeth with no clinical signs of pulp degeneration.</measure>
    <time_frame>9 months postoperatively</time_frame>
    <description>Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Teeth with no clinical signs of pulp degeneration.</measure>
    <time_frame>12 months postoperatively</time_frame>
    <description>Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Teeth with no radiographic signs of pulp degeneration.</measure>
    <time_frame>6 months postoperatively</time_frame>
    <description>Digital postoperative periapical radiographs were obtained and assessed for signs of pulp degeneration. Teeth were considered radiographically successful when they showed no periapical or interradicular radiolucency, abnormal root resorption or periodontal ligament space widening</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Percentage of Teeth with no radiographic signs of pulp degeneration.</measure>
    <time_frame>12 months postoperatively</time_frame>
    <description>Digital postoperative periapical radiographs were obtained and assessed for signs of pulp degeneration. Teeth were considered radiographically successful when they showed no periapical or interradicular radiolucency, abnormal root resorption or periodontal ligament space widening</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of teeth with radiographic evidence of dentin bridge formation</measure>
    <time_frame>6 months postoperatively</time_frame>
    <description>Assessed using digital radiographs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Percentage of teeth with radiographic evidence of dentin bridge formation</measure>
    <time_frame>12 months postoperatively</time_frame>
    <description>Assessed using digital radiographs</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Dentin bridge formation using light microscopy</measure>
    <time_frame>6 weeks</time_frame>
    <description>After tooth extraction, histological assessment will be done according to Horsted et al's (1981) and Shayegan et al's (2012) modified criteria.&#xD;
0= No hard tissue formation.&#xD;
Incomplete hard tissue formation.&#xD;
Thick hard tissue formation.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflammatory response using light microscopy</measure>
    <time_frame>6 weeks</time_frame>
    <description>After tooth extraction, histological assessment will be done according to Horsted et al's (1981) and Shayegan et al's (2012) modified criteria. A. Inflammatory cell response:&#xD;
0= None or a few scattered inflammatory cells beneath the site of pulp exposure.&#xD;
Mild inflammatory cells (either acute or chronic).&#xD;
Moderate inflammatory cell infiltration involving the cervical third of radicular pulp.&#xD;
Severe inflammatory cell infiltration involving the coronal third of radicular pulp.&#xD;
B. Tissue disorganization:&#xD;
0= Normal tissue beneath the site of pulp exposure.&#xD;
Odontoblast-like cells, odontoblasts, and pulp tissue pattern disorganization.&#xD;
General disorganization of the pulp tissue pattern.&#xD;
Pulp necrosis.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>The Enzyme-Linked Immunosorbent Assay (ELISA) analysis.</measure>
    <time_frame>6 weeks</time_frame>
    <description>After extraction, the tooth will be sectioned under copious water cooling and all remaining pulp tissue will be harvested gently from the radicular portion and stored until the time of assaying. For the ELISA assaying, the frozen pulp samples will be thawed for 15 minutes, and crushed with a glass rod in the eppendorf tube to elute the cytokines from the pulp tissue. IL-8 and IL-10 will be measured using ElISA Kits according to the instructions supplied with the kit and the ratio of IL-8/IL-10 will be taken as an indicator of pulpal inflammation. Cytokines' concentration will be calculated according to the weight of the pulp tissue.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">102</enrollment>
  <condition>Pulpotomy</condition>
  <arm_group>
    <arm_group_label>TAMP bioglass</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tailored amorphous multiporous bioglass (TAMP-BG) of 70% SiO2 / 30% CaO was prepared according to Wang et al. (2011, 2013) in the tissue engineering lab, Faculty of Dentistry, Alexandria University as follows: Scaffolds were grounded to 180- to 300-μm particle size and sterilized at 180°C for 2 hours. The resulting powder was mixed with distilled water to obtain a putty like consistency that was carried to the pulp chamber and condensed lightly on the pulp stumps.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Biodentine ™</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Biodentine ™ (BD) pre-dosed capsule were gently tapped on a hard surface to diffuse the powder. Five drops of the liquid from the single dose dispenser were poured into the capsule and mixed for 30 seconds at 4,200 rpm in an amalgamator according to manufacturer's instructions to obtain putty- like consistency. (Powder-liquid system). It was then be carried to the pulp chamber and condensed lightly on the pulp stumps. Final restoration was applied after 12 minutes, allowing Biodentine ™ to set.</description>
  </arm_group>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>TAMP bioglass</intervention_name>
    <description>TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth</description>
    <arm_group_label>TAMP bioglass</arm_group_label>
    <other_name>70S30C bioglass</other_name>
  </intervention>
  <intervention>
    <intervention_type>Drug</intervention_type>
    <intervention_name>Biodentine</intervention_name>
    <description>TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth</description>
    <arm_group_label>Biodentine ™</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Children free of any systemic disease or special health care needs.&#xD;
&#xD;
          -  Children not receiving any anti-inflammatory medication.&#xD;
&#xD;
          -  Cooperative children (positive/ definitely positive) according to Frankl's behavior&#xD;
             rating scale.&#xD;
&#xD;
          -  Restorable teeth.&#xD;
&#xD;
          -  Teeth with vital carious pulp exposure that will bleed upon entering the pulp chamber&#xD;
             and not requiring more than 5 minutes to achieve hemostasis after coronal pulp&#xD;
             amputation.&#xD;
&#xD;
          -  Teeth indicated for extraction for orthodontic purposes with the previously mentioned&#xD;
             criteria (required for a subgroup for assessment of histological and inflammatory&#xD;
             response outcomes).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Teeth with clinical or radiographic signs of pulp degeneration.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>5 Years</minimum_age>
    <maximum_age>9 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Yasmine I El-Hamouly, MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Karin ML Dowidar, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Samia Soliman, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Dalia AM Talaat, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Rania M El Backly, PhD</last_name>
    <role>Study Director</role>
    <affiliation>Alexandria University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Dentistry, Alexandria University</name>
      <address>
        <city>Alexandria</city>
        <zip>21512</zip>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Wang S, Falk MM, Rashad A, Saad MM, Marques AC, Almeida RM, Marei MK, Jain H. Evaluation of 3D nano-macro porous bioactive glass scaffold for hard tissue engineering. J Mater Sci Mater Med. 2011 May;22(5):1195-203. doi: 10.1007/s10856-011-4297-4. Epub 2011 Mar 29.</citation>
    <PMID>21445655</PMID>
  </reference>
  <reference>
    <citation>Wang S, Kowal TJ, Marei MK, Falk MM, Jain H. Nanoporosity significantly enhances the biological performance of engineered glass tissue scaffolds. Tissue Eng Part A. 2013 Jul;19(13-14):1632-40. doi: 10.1089/ten.TEA.2012.0585. Epub 2013 Mar 26.</citation>
    <PMID>23427819</PMID>
  </reference>
  <reference>
    <citation>Stanley HR, Clark AE, Pameijer CH, Louw NP. Pulp capping with a modified bioglass formula (#A68-modified). Am J Dent. 2001 Aug;14(4):227-32.</citation>
    <PMID>11699742</PMID>
  </reference>
  <reference>
    <citation>Horsted P, El Attar K, Langeland K. Capping of monkey pulps with Dycal and a Ca-eugenol cement. Oral Surg Oral Med Oral Pathol. 1981 Nov;52(5):531-53. doi: 10.1016/0030-4220(81)90366-2.</citation>
    <PMID>6946381</PMID>
  </reference>
  <reference>
    <citation>Shayegan A, Jurysta C, Atash R, Petein M, Abbeele AV. Biodentine used as a pulp-capping agent in primary pig teeth. Pediatr Dent. 2012 Nov-Dec;34(7):e202-8.</citation>
    <PMID>23265156</PMID>
  </reference>
  <verification_date>October 2020</verification_date>
  <study_first_submitted>December 18, 2018</study_first_submitted>
  <study_first_submitted_qc>December 19, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 26, 2018</study_first_posted>
  <last_update_submitted>October 11, 2020</last_update_submitted>
  <last_update_submitted_qc>October 11, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">October 14, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Alexandria</investigator_affiliation>
    <investigator_full_name>Nourhan M.Aly</investigator_full_name>
    <investigator_title>Clinical Instructor</investigator_title>
  </responsible_party>
  <keyword>TAMP BG</keyword>
  <keyword>Biodentine</keyword>
  <keyword>Regenerative materials</keyword>
  <keyword>pulp therapy</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/NCT03786302
org study id: Bioglass in pulpotomized teeth
nct id: NCT03786302
lead sponsor: 
collaborator: 
is fda regulated drug: No
is fda regulated device: No
The aim of this study was to assess clinically, radiographically, and histologically the
      regenerative ability of Tailored Amorphous Mulioporous (TAMP-BG) bioglass in comparison to
      Biodentine™ (BD) in pulpotomized primary teeth.
The study was a parallel design, randomized controlled clinical trial It was conducted in the
      out-patient clinic of the Pediatric Dentistry and Dental public health department after
      obtaining the guardians consent. The sample size was calculated to be 35 teeth per group. The
      teeth were randomly and equally assigned to either BD or TAMP-BG groups.The treatment
      follow-up was scheduled at 1, 3, 6, 9 and 12 months. The study was terminated for ethical
      considerations after showing significant clinical failure in the TAMP-BG group and after
      performing interim analysis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Study group (assigned to TAMP bioglass), and Control group (assigned to Biodentine ™).
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Outcomes Assessor)
masking description: The operator will not be blinded to the treatment type. However, the participants, their care givers, the expert assessing the histologic and inflammatory changes and the statistician will be blinded to the treatment groups.
measure: Absence of clinical signs of pulp degeneration.
time frame: 1 month postoperatively
description: Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility
measure: Percentage of Teeth with no clinical signs of pulp degeneration.
time frame: 3 months postoperatively
description: Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility
measure: Percentage of Teeth with no clinical signs of pulp degeneration.
time frame: 6 months postoperatively
description: Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility
measure: Percentage of Teeth with no clinical signs of pulp degeneration.
time frame: 9 months postoperatively
description: Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility
measure: Percentage of Teeth with no clinical signs of pulp degeneration.
time frame: 12 months postoperatively
description: Teeth were considered clinically successful when they showed no signs of pain, sensitivity to percussion, swelling, fistula or pathologic mobility
measure: Percentage of Teeth with no radiographic signs of pulp degeneration.
time frame: 6 months postoperatively
description: Digital postoperative periapical radiographs were obtained and assessed for signs of pulp degeneration. Teeth were considered radiographically successful when they showed no periapical or interradicular radiolucency, abnormal root resorption or periodontal ligament space widening
measure: Percentage of Teeth with no radiographic signs of pulp degeneration.
time frame: 12 months postoperatively
description: Digital postoperative periapical radiographs were obtained and assessed for signs of pulp degeneration. Teeth were considered radiographically successful when they showed no periapical or interradicular radiolucency, abnormal root resorption or periodontal ligament space widening
measure: Percentage of teeth with radiographic evidence of dentin bridge formation
time frame: 6 months postoperatively
description: Assessed using digital radiographs
measure: Percentage of teeth with radiographic evidence of dentin bridge formation
time frame: 12 months postoperatively
description: Assessed using digital radiographs
measure: Dentin bridge formation using light microscopy
time frame: 6 weeks
description: After tooth extraction, histological assessment will be done according to Horsted et al's (1981) and Shayegan et al's (2012) modified criteria.
0= No hard tissue formation.
Incomplete hard tissue formation.
Thick hard tissue formation.
measure: Inflammatory response using light microscopy
time frame: 6 weeks
description: After tooth extraction, histological assessment will be done according to Horsted et al's (1981) and Shayegan et al's (2012) modified criteria. A. Inflammatory cell response:
0= None or a few scattered inflammatory cells beneath the site of pulp exposure.
Mild inflammatory cells (either acute or chronic).
Moderate inflammatory cell infiltration involving the cervical third of radicular pulp.
Severe inflammatory cell infiltration involving the coronal third of radicular pulp.
B. Tissue disorganization:
0= Normal tissue beneath the site of pulp exposure.
Odontoblast-like cells, odontoblasts, and pulp tissue pattern disorganization.
General disorganization of the pulp tissue pattern.
Pulp necrosis.
measure: The Enzyme-Linked Immunosorbent Assay (ELISA) analysis.
time frame: 6 weeks
description: After extraction, the tooth will be sectioned under copious water cooling and all remaining pulp tissue will be harvested gently from the radicular portion and stored until the time of assaying. For the ELISA assaying, the frozen pulp samples will be thawed for 15 minutes, and crushed with a glass rod in the eppendorf tube to elute the cytokines from the pulp tissue. IL-8 and IL-10 will be measured using ElISA Kits according to the instructions supplied with the kit and the ratio of IL-8/IL-10 will be taken as an indicator of pulpal inflammation. Cytokines' concentration will be calculated according to the weight of the pulp tissue.
arm group label: TAMP bioglass
arm group type: Experimental
description: Tailored amorphous multiporous bioglass (TAMP-BG) of 70% SiO2 / 30% CaO was prepared according to Wang et al. (2011, 2013) in the tissue engineering lab, Faculty of Dentistry, Alexandria University as follows: Scaffolds were grounded to 180- to 300-μm particle size and sterilized at 180°C for 2 hours. The resulting powder was mixed with distilled water to obtain a putty like consistency that was carried to the pulp chamber and condensed lightly on the pulp stumps.
arm group label: Biodentine ™
arm group type: Active Comparator
description: Biodentine ™ (BD) pre-dosed capsule were gently tapped on a hard surface to diffuse the powder. Five drops of the liquid from the single dose dispenser were poured into the capsule and mixed for 30 seconds at 4,200 rpm in an amalgamator according to manufacturer's instructions to obtain putty- like consistency. (Powder-liquid system). It was then be carried to the pulp chamber and condensed lightly on the pulp stumps. Final restoration was applied after 12 minutes, allowing Biodentine ™ to set.
intervention type: Drug
intervention name: TAMP bioglass
description: TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth
arm group label: TAMP bioglass
other name: 70S30C bioglass
intervention type: Drug
intervention name: Biodentine
description: TAMP bioglass compared to Biodentine in the regeneration on pulpotomized primary teeth
arm group label: Biodentine ™
criteria: 
gender: All
minimum age: 5 Years
maximum age: 9 Years
healthy volunteers: No
last name: Yasmine I El-Hamouly, MSc
role: Principal Investigator
affiliation: Alexandria University
last name: Karin ML Dowidar, PhD
role: Study Director
affiliation: Alexandria University
last name: Samia Soliman, PhD
role: Study Director
affiliation: Alexandria University
last name: Dalia AM Talaat, PhD
role: Study Director
affiliation: Alexandria University
last name: Rania M El Backly, PhD
role: Study Director
affiliation: Alexandria University
facility: 
country: Egypt
citation: Wang S, Falk MM, Rashad A, Saad MM, Marques AC, Almeida RM, Marei MK, Jain H. Evaluation of 3D nano-macro porous bioactive glass scaffold for hard tissue engineering. J Mater Sci Mater Med. 2011 May;22(5):1195-203. doi: 10.1007/s10856-011-4297-4. Epub 2011 Mar 29.
PMID: 21445655
citation: Wang S, Kowal TJ, Marei MK, Falk MM, Jain H. Nanoporosity significantly enhances the biological performance of engineered glass tissue scaffolds. Tissue Eng Part A. 2013 Jul;19(13-14):1632-40. doi: 10.1089/ten.TEA.2012.0585. Epub 2013 Mar 26.
PMID: 23427819
citation: Stanley HR, Clark AE, Pameijer CH, Louw NP. Pulp capping with a modified bioglass formula (#A68-modified). Am J Dent. 2001 Aug;14(4):227-32.
PMID: 11699742
citation: Horsted P, El Attar K, Langeland K. Capping of monkey pulps with Dycal and a Ca-eugenol cement. Oral Surg Oral Med Oral Pathol. 1981 Nov;52(5):531-53. doi: 10.1016/0030-4220(81)90366-2.
PMID: 6946381
citation: Shayegan A, Jurysta C, Atash R, Petein M, Abbeele AV. Biodentine used as a pulp-capping agent in primary pig teeth. Pediatr Dent. 2012 Nov-Dec;34(7):e202-8.
PMID: 23265156
responsible party type: Sponsor-Investigator
investigator affiliation: University of Alexandria
investigator full name: Nourhan M.Aly
investigator title: Clinical Instructor