xml: <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/NCT05981352</url>
    </required_header>
    <id_info>
      <org_study_id>Pulpotomy of Primary Molars</org_study_id>
      <nct_id>NCT05981352</nct_id>
    </id_info>
    <brief_title>Evaluation of Different Materials in Pulpotomy of Primary Molars</brief_title>
    <official_title>Clinical, Radiographic and Microbiological Evaluation of Hyaluronic Acid and Amniotic Membrane Allograft in Comparison to Mineral Trioxide Aggregate in Pulpotomy of Primary Molars (Randomized Clinical Trial and In Vitro Study)</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Ain Shams University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Ain Shams University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>Yes</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the current study is to evaluate and compare clinical and radiographic success and&#xD;
        antibacterial effect of Hyaluronic Acid and Amniotic membrane pulpotomy in primary molars in&#xD;
        comparison with MTA pulpotomy (Randomized Clinical Trial and In Vitro Study).&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Pulpotomy is one of the most used frequently treatment for pulp involved in primary teeth.&#xD;
        Pulpotomy is performed in a primary tooth with extensive caries but without evidence of&#xD;
        radicular pathology when caries removal results in a carious or mechanical pulp exposure. It&#xD;
        is a conservative therapy performed to remove the inflamed coronal pulp tissues followed by&#xD;
        application of an effective and compatible bactericidal medicament.&#xD;
  &#xD;
        Many different compounds have been suggested include glutaraldehyde, electrosurgery, calcium&#xD;
        hydroxide, ferric sulfate, freeze-dried bone, bone morphogenic proteins (BMP), mineral&#xD;
        trioxide aggregate (MTA) and Bio dentine (Tricalcium Silicate Cement) as replacement for Form&#xD;
        cresol in pulpotomy procedure however.&#xD;
  &#xD;
        Pulpotomy has been broadly classified as devitalization, preservation, and regeneration of&#xD;
        the remaining pulp tissue. Other materials that has shown immense potential for regeneration&#xD;
        like mineral trioxide aggregate (MTA). It is a biocompatible and bio inductive material that&#xD;
        has been investigated for endodontic.&#xD;
  &#xD;
        Hyaluronic acid (HA) has recently emerged as a material of choice in preserving the vitality&#xD;
        of the pulp. It is a natural mucopolysaccharide, carbohydrate polymer from the group of&#xD;
        glycosaminoglycans. HA is synthetized on the cytoplasmic surface of plasma membranes and is&#xD;
        common in humans and other vertebrates. It is the major component of the inner-cell cement of&#xD;
        the capillary wall, and of the extracellular matrix of the connective tissue. Deposition of&#xD;
        HA significantly increases during development, morphogenesis, wound repair and regeneration,&#xD;
        malignancy, and inflammation.&#xD;
  &#xD;
        Hyaluronic acid (HA) or hyaluronan is a hydrated anionic polysaccharide plentiful in the&#xD;
        extracellular matrix with a molecular weight of 4000-20,000,000 Da that is found in a variety&#xD;
        of tissues including skin, synovial fluid, cartilage, tendons, eyes and embryonic mesenchyme&#xD;
        . It is comprised of repeating disaccharides d-glucuronic acid and N-acetyl-d-glucosamine,&#xD;
        which are joined together by alternating β-1,4 and β-1,3 glycoside bonding. During bone&#xD;
        repair, it encourages the undifferentiated mesenchymal cells to migrate, adhere, and&#xD;
        proliferate into osteoblastic cells. Due to its non-toxicity, biocompatibility,&#xD;
        biodegradability and non-immunogenicity, and used in ophthalmology and orthopedics as an&#xD;
        anti-inflammatory agent and anti bacterial agent.&#xD;
  &#xD;
        The use of a hyaluronic acid to cover a dentin defect, stimulated a cell-rich rearrangement&#xD;
        of pulp tissue with few inflammatory cells, as well as being an acceptable and biocompatible&#xD;
        scaffold for regenerating the dental pulp. Because of its high molecular weight when&#xD;
        dissolved in water, hyaluronic acid's viscoelasticity increases, making it simpler to use as&#xD;
        an injectable scaffold. Moreover, advantageous characteristics are related to the hyaluronic&#xD;
        acid scaffolds as bioactivity, biocompatibility, biodegradability, in addition to serving as&#xD;
        a reservoir for growth factors..&#xD;
  &#xD;
        It is important to propose new biologically based therapeutics directed at preserving pulp&#xD;
        vitality , forming biological tissue and neutralizing the side effects of previously used&#xD;
        synthetically based biomaterials .&#xD;
  &#xD;
        Recently, novel biologically based materials have been developed from the placenta or other&#xD;
        gestational tissues like the umbilical cord with highly rich stem cell reservoirs . Amniotic&#xD;
        membrane (AM) is a fetes membranous sac forming the innermost layer of the placenta. It is a&#xD;
        bi-layered membrane consists of amnion and chorion. Amnion consists of 3 distinct thin&#xD;
        layers: an epithelial monolayer (closest to the fetes),a basement membrane and avascular&#xD;
        mesenchymal stromal matrix (containing mesenchymal stem cells) that composed of 3 adjacent&#xD;
        but distinct layers: outermost spongy, middle fibroblastic and inner compact.&#xD;
  &#xD;
        Although it is a thin membrane (70-180 μm thick), it is remarkably elastic and strong natural&#xD;
        biological barricade protecting the fetus from trauma and bacterial infection . In contrast,&#xD;
        the chorion is 3-4 times thicker than amnion and consists of a reticular, basement membrane,&#xD;
        and trophoblastic layers. Both membranes play important roles in embryo's overall&#xD;
        development, embryo's nourishment and breathing .&#xD;
  &#xD;
        Amniotic membrane matrix contains plenteous growth factors (GFs) including basic-fibroblast&#xD;
        growth factor (b-FGF), nidogen growth factor (NGF), keratinocyte growth factor (KGF),&#xD;
        epidermal derived growth factor (EDGF), and transforming GF-beta growth factor (TGF-β) which&#xD;
        promote tissue regeneration . These GFs mimic the stem cell niche for ex vivo growth and&#xD;
        provide a natural healing environment. It acts as a structural scaffold supporting&#xD;
        proliferation, differentiation, and regeneration due to presence of fibronectin, laminins,&#xD;
        proteoglycans, collagen types I, III, IV, V and VI, elastin, nidogen, and hyaluronic acid in&#xD;
        its stromal layer, and act as an excellent candidature for a native scaffold in tissue&#xD;
        engineering .&#xD;
  &#xD;
        Furthermore, it secretes nutrient factors , promotes cell migration, adhesion,&#xD;
        differentiation, and suppresses the semi allogenic immune response against the foetus . In&#xD;
        addition, it has a biological, anti-inflammatory (similar to cortisone and steroids shots),&#xD;
        anti-fibrotic, anti-microbial (including beta-defensins), anti-scarring, anti-angiogenic and&#xD;
        analgesic properties that make it a unique therapy for wound care and ideal substrate for&#xD;
        supporting the growth of mesenchymal progenitor cells via prolonging their lifespan&#xD;
  &#xD;
        It is used in allotransplant due to its ability to promote cellular growth and attachment&#xD;
        with the lack of its immunogenicity and toxicity; it was first reported by Davis since 1910&#xD;
        in skin transplantation. Also, it has been used successfully for over a decade in a wide&#xD;
        range of surgical application, biological wound dressing, ophthalmic reconstructive surgery,&#xD;
        an adhesion barrier in the spine, and in-ear and orthopedic surgery. It is easily obtained,&#xD;
        processed, transported, and prepared in different forms for clinical use like fresh, dried,&#xD;
        frozen, freeze derived irradiated, stabilized amniotic and cryopreserved membranes .&#xD;
  &#xD;
        Amnion-based products have a proven rate of success in the field of dentistry since 1990s,&#xD;
        when first demonstrated safety and efficacy in pre-and clinical studies . The dehydrated or&#xD;
        cryopreserved membrane is used for retaining the majority of the natural (fibrillar and&#xD;
        membranous) collagens, maintaining the composition of GFs and bioactive molecules found in&#xD;
        natural and unprocessed placental tissues, and increasing stability and shelf life of the&#xD;
        product .&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">October 2023</start_date>
    <completion_date type="Anticipated">October 1, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 1, 2024</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 pulp testing</measure>
      <time_frame>0 baseline , changes from baseline pulp condition at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month.</time_frame>
      <description>pulp testing clinically measured by zurn and seale criteria ,</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Radio graphic pulp testing</measure>
      <time_frame>0 baseline , changes from baseline pulp condition at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month.</time_frame>
      <description>pulp testing radio graphic measured by digital radio graph parallel technique</description>
    </primary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Pulp Disease, Dental</condition>
    <arm_group>
      <arm_group_label>Mineral trioxide aggregate (positive control group)</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>: according to the manufacturing instructions as following:&#xD;
  After achieving hemostasis, Mineral trioxide aggregate powder will be mixed with saline.&#xD;
  Then Mineral trioxide aggregate will be placed directly on the pulp stumps.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Dehydrated amniotic membrane group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>After achieving hemostasis, a double layer of sterile processed human allograft tissue (dehydrated dual-layer dental amnion patch) will be trimmed and soaked in saline for a minute.&#xD;
  Dehydrated amniotic membrane will be Placed directly on the pup stumps using sterile tweezers and adjusted to the entire floor of the pulp chamber.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Hyaluronic acid group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>• After achieving hemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder with consistency (1:1 ratio by volume) .</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>mineral trioxide aggregate pulpotomy</intervention_name>
      <description>After achieving hemostats, Mineral trioxide aggregate powder will be mixed with saline.&#xD;
  Then Mineral trioxide aggregate will be placed directly on the pulp stumps.</description>
      <arm_group_label>Mineral trioxide aggregate (positive control group)</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Dehydrated amniotic membrane pulpotomy</intervention_name>
      <description>After achieving haemostasis, a double layer of sterile processed human allograft tis¬sue (dehydrated dual-layer dental amni¬on patch) will be trimed and soaked in saline for a minute.&#xD;
  Dehydrated amniotic membrane will be Placed directly on the pup stumps using sterile tweezers and adjust¬ed to the entire floor of the pulp chamber.</description>
      <arm_group_label>Dehydrated amniotic membrane group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Hyaluronic acid pulpotomy</intervention_name>
      <description>After achieving haemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder with consistency (1:1 ratio by volume) .&#xD;
  The cavities of all pulpotomy molars will be sealed with a layer of reinforced zinc oxide and eugenol .</description>
      <arm_group_label>Hyaluronic acid group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Patients aged from 4 to 8 years old.&#xD;
  &#xD;
            -  Patients who are free from ant medical condition.&#xD;
  &#xD;
            -  Patients who have a vital deep carious Mandibular primary molar which is indicated for&#xD;
               pulpotomy .&#xD;
  &#xD;
            -  No clinical signs or symptoms of irreversible pulpitis as pain on percussion, tooth&#xD;
               mobility, presence of sinus or fistula, history of swelling , Spontaneous pain.&#xD;
  &#xD;
            -  No radiographic evidence of any periapical pathosis , Internal or external root&#xD;
               resorption , Absence of discontinuity of lamina dura .&#xD;
  &#xD;
            -  Physiological root resorption not more than 1/3 of crown&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Teeth that are badly broken down, that cannot be restored.&#xD;
  &#xD;
            -  Presence of uncontrolled bleeding after pulpotomy&#xD;
  &#xD;
            -  Patients/ parent guardians that refuse to sign informed consent.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>4 Years</minimum_age>
      <maximum_age>8 Years</maximum_age>
      <healthy_volunteers>No</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>eman Ib Abdel Maksoud, doctor</last_name>
      <role>Study Chair</role>
      <affiliation>Ain Shams University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>eman Ib Abdel Masoud, doctor</last_name>
      <phone>01555682322</phone>
      <email>eman.abdelmaksoud@dent.asu.edu.eg</email>
    </overall_contact>
    <verification_date>May 2023</verification_date>
    <study_first_submitted>January 26, 2023</study_first_submitted>
    <study_first_submitted_qc>July 31, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 8, 2023</study_first_posted>
    <last_update_submitted>August 22, 2023</last_update_submitted>
    <last_update_submitted_qc>August 22, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Pulp Diseases</mesh_term>
      <mesh_term>Stomatognathic Diseases</mesh_term>
    </condition_browse>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Hyaluronic Acid</mesh_term>
    </intervention_browse>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05981352
  org study id: Pulpotomy of Primary Molars
  nct id: NCT05981352
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: Yes
  The aim of the current study is to evaluate and compare clinical and radiographic success and
        antibacterial effect of Hyaluronic Acid and Amniotic membrane pulpotomy in primary molars in
        comparison with MTA pulpotomy (Randomized Clinical Trial and In Vitro Study).
  Pulpotomy is one of the most used frequently treatment for pulp involved in primary teeth.
        Pulpotomy is performed in a primary tooth with extensive caries but without evidence of
        radicular pathology when caries removal results in a carious or mechanical pulp exposure. It
        is a conservative therapy performed to remove the inflamed coronal pulp tissues followed by
        application of an effective and compatible bactericidal medicament.
  
        Many different compounds have been suggested include glutaraldehyde, electrosurgery, calcium
        hydroxide, ferric sulfate, freeze-dried bone, bone morphogenic proteins (BMP), mineral
        trioxide aggregate (MTA) and Bio dentine (Tricalcium Silicate Cement) as replacement for Form
        cresol in pulpotomy procedure however.
  
        Pulpotomy has been broadly classified as devitalization, preservation, and regeneration of
        the remaining pulp tissue. Other materials that has shown immense potential for regeneration
        like mineral trioxide aggregate (MTA). It is a biocompatible and bio inductive material that
        has been investigated for endodontic.
  
        Hyaluronic acid (HA) has recently emerged as a material of choice in preserving the vitality
        of the pulp. It is a natural mucopolysaccharide, carbohydrate polymer from the group of
        glycosaminoglycans. HA is synthetized on the cytoplasmic surface of plasma membranes and is
        common in humans and other vertebrates. It is the major component of the inner-cell cement of
        the capillary wall, and of the extracellular matrix of the connective tissue. Deposition of
        HA significantly increases during development, morphogenesis, wound repair and regeneration,
        malignancy, and inflammation.
  
        Hyaluronic acid (HA) or hyaluronan is a hydrated anionic polysaccharide plentiful in the
        extracellular matrix with a molecular weight of 4000-20,000,000 Da that is found in a variety
        of tissues including skin, synovial fluid, cartilage, tendons, eyes and embryonic mesenchyme
        . It is comprised of repeating disaccharides d-glucuronic acid and N-acetyl-d-glucosamine,
        which are joined together by alternating β-1,4 and β-1,3 glycoside bonding. During bone
        repair, it encourages the undifferentiated mesenchymal cells to migrate, adhere, and
        proliferate into osteoblastic cells. Due to its non-toxicity, biocompatibility,
        biodegradability and non-immunogenicity, and used in ophthalmology and orthopedics as an
        anti-inflammatory agent and anti bacterial agent.
  
        The use of a hyaluronic acid to cover a dentin defect, stimulated a cell-rich rearrangement
        of pulp tissue with few inflammatory cells, as well as being an acceptable and biocompatible
        scaffold for regenerating the dental pulp. Because of its high molecular weight when
        dissolved in water, hyaluronic acid's viscoelasticity increases, making it simpler to use as
        an injectable scaffold. Moreover, advantageous characteristics are related to the hyaluronic
        acid scaffolds as bioactivity, biocompatibility, biodegradability, in addition to serving as
        a reservoir for growth factors..
  
        It is important to propose new biologically based therapeutics directed at preserving pulp
        vitality , forming biological tissue and neutralizing the side effects of previously used
        synthetically based biomaterials .
  
        Recently, novel biologically based materials have been developed from the placenta or other
        gestational tissues like the umbilical cord with highly rich stem cell reservoirs . Amniotic
        membrane (AM) is a fetes membranous sac forming the innermost layer of the placenta. It is a
        bi-layered membrane consists of amnion and chorion. Amnion consists of 3 distinct thin
        layers: an epithelial monolayer (closest to the fetes),a basement membrane and avascular
        mesenchymal stromal matrix (containing mesenchymal stem cells) that composed of 3 adjacent
        but distinct layers: outermost spongy, middle fibroblastic and inner compact.
  
        Although it is a thin membrane (70-180 μm thick), it is remarkably elastic and strong natural
        biological barricade protecting the fetus from trauma and bacterial infection . In contrast,
        the chorion is 3-4 times thicker than amnion and consists of a reticular, basement membrane,
        and trophoblastic layers. Both membranes play important roles in embryo's overall
        development, embryo's nourishment and breathing .
  
        Amniotic membrane matrix contains plenteous growth factors (GFs) including basic-fibroblast
        growth factor (b-FGF), nidogen growth factor (NGF), keratinocyte growth factor (KGF),
        epidermal derived growth factor (EDGF), and transforming GF-beta growth factor (TGF-β) which
        promote tissue regeneration . These GFs mimic the stem cell niche for ex vivo growth and
        provide a natural healing environment. It acts as a structural scaffold supporting
        proliferation, differentiation, and regeneration due to presence of fibronectin, laminins,
        proteoglycans, collagen types I, III, IV, V and VI, elastin, nidogen, and hyaluronic acid in
        its stromal layer, and act as an excellent candidature for a native scaffold in tissue
        engineering .
  
        Furthermore, it secretes nutrient factors , promotes cell migration, adhesion,
        differentiation, and suppresses the semi allogenic immune response against the foetus . In
        addition, it has a biological, anti-inflammatory (similar to cortisone and steroids shots),
        anti-fibrotic, anti-microbial (including beta-defensins), anti-scarring, anti-angiogenic and
        analgesic properties that make it a unique therapy for wound care and ideal substrate for
        supporting the growth of mesenchymal progenitor cells via prolonging their lifespan
  
        It is used in allotransplant due to its ability to promote cellular growth and attachment
        with the lack of its immunogenicity and toxicity; it was first reported by Davis since 1910
        in skin transplantation. Also, it has been used successfully for over a decade in a wide
        range of surgical application, biological wound dressing, ophthalmic reconstructive surgery,
        an adhesion barrier in the spine, and in-ear and orthopedic surgery. It is easily obtained,
        processed, transported, and prepared in different forms for clinical use like fresh, dried,
        frozen, freeze derived irradiated, stabilized amniotic and cryopreserved membranes .
  
        Amnion-based products have a proven rate of success in the field of dentistry since 1990s,
        when first demonstrated safety and efficacy in pre-and clinical studies . The dehydrated or
        cryopreserved membrane is used for retaining the majority of the natural (fibrillar and
        membranous) collagens, maintaining the composition of GFs and bioactive molecules found in
        natural and unprocessed placental tissues, and increasing stability and shelf life of the
        product .
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Double (Participant, Care Provider)
  measure: clinical pulp testing
  time frame: 0 baseline , changes from baseline pulp condition at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month.
  description: pulp testing clinically measured by zurn and seale criteria ,
  measure: Radio graphic pulp testing
  time frame: 0 baseline , changes from baseline pulp condition at 3 month, change from the baseline pulp condition at 6 month, change from baseline pulp condition at 9 month, change from base line pulp condition at 12 month.
  description: pulp testing radio graphic measured by digital radio graph parallel technique
  arm group label: Mineral trioxide aggregate (positive control group)
  arm group type: Active Comparator
  description: : according to the manufacturing instructions as following:
  After achieving hemostasis, Mineral trioxide aggregate powder will be mixed with saline.
  Then Mineral trioxide aggregate will be placed directly on the pulp stumps.
  arm group label: Dehydrated amniotic membrane group
  arm group type: Experimental
  description: After achieving hemostasis, a double layer of sterile processed human allograft tissue (dehydrated dual-layer dental amnion patch) will be trimmed and soaked in saline for a minute.
  Dehydrated amniotic membrane will be Placed directly on the pup stumps using sterile tweezers and adjusted to the entire floor of the pulp chamber.
  arm group label: Hyaluronic acid group
  arm group type: Experimental
  description: • After achieving hemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder with consistency (1:1 ratio by volume) .
  intervention type: Procedure
  intervention name: mineral trioxide aggregate pulpotomy
  description: After achieving hemostats, Mineral trioxide aggregate powder will be mixed with saline.
  Then Mineral trioxide aggregate will be placed directly on the pulp stumps.
  arm group label: Mineral trioxide aggregate (positive control group)
  intervention type: Procedure
  intervention name: Dehydrated amniotic membrane pulpotomy
  description: After achieving haemostasis, a double layer of sterile processed human allograft tis¬sue (dehydrated dual-layer dental amni¬on patch) will be trimed and soaked in saline for a minute.
  Dehydrated amniotic membrane will be Placed directly on the pup stumps using sterile tweezers and adjust¬ed to the entire floor of the pulp chamber.
  arm group label: Dehydrated amniotic membrane group
  intervention type: Procedure
  intervention name: Hyaluronic acid pulpotomy
  description: After achieving haemostasis, pulp stumps will be covered with a mixture of Hyaluronic acid gel and zinc oxide powder with consistency (1:1 ratio by volume) .
  The cavities of all pulpotomy molars will be sealed with a layer of reinforced zinc oxide and eugenol .
  arm group label: Hyaluronic acid group
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 8 Years
  healthy volunteers: No
  last name: eman Ib Abdel Maksoud, doctor
  role: Study Chair
  affiliation: Ain Shams University
  last name: eman Ib Abdel Masoud, doctor
  phone: 01555682322
  email: eman.abdelmaksoud@dent.asu.edu.eg
  responsible party type: Sponsor
  mesh term: Dental Pulp Diseases
  mesh term: Stomatognathic Diseases
  mesh term: Hyaluronic Acid