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/NCT06000085</url>
    </required_header>
    <id_info>
      <org_study_id>PED 22-4D</org_study_id>
      <nct_id>NCT06000085</nct_id>
    </id_info>
    <brief_title>Clinical Performance of Two Different Restorative Materials in Restoring Class II Cavities of Primary Molars</brief_title>
    <official_title>Clinical Performance of a Flowable Giomer Versus a Highly Viscous Glass-ionomer Cement in Restoring Class II Cavities of Primary Molars: A Randomized Clinical Trial</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>
    </oversight_info>
    <brief_summary>
      <textblock>
        The aim of the present study is to assess Flowable Giomer Beautifil Flow Plus X (Shofu Dental&#xD;
        Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo,&#xD;
  &#xD;
        Japan) in class II cavities of primary molars regarding the following objectives:&#xD;
  &#xD;
        The primary objective To evaluate and compare the clinical performance of Flowable Giomer&#xD;
        Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia&#xD;
        Forte (GC Corporation, Tokyo, Japan) in restoring class II cavities of primary molars after&#xD;
        3,6, and 12 months. The secondary objective To assess the effect of different independent&#xD;
        variables on the treatment outcome of the experimental restorative materials.&#xD;
  &#xD;
        Research question:&#xD;
  &#xD;
        Is there a difference in the clinical performance between flowable giomers and highly viscous&#xD;
        glass ionomer in restoring class II cavities of primary molars?&#xD;
  &#xD;
        Null Hypothesis There is no difference in the clinical performance between Flowable Giomer&#xD;
        Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia&#xD;
        Forte (GC Corporation, Tokyo, Japan) after one year of follow up.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Study design:&#xD;
  &#xD;
        The study will be two parallel-arm, double blinded randomized, controlled clinical trial with&#xD;
        an equal allocation ratio.&#xD;
  &#xD;
        Study Setting:&#xD;
  &#xD;
        The study will be conducted at Pediatric dentistry and Dental Public Health Department,&#xD;
        Faculty of Dentistry, Ain Shams University.&#xD;
  &#xD;
        Ethical Considerations:&#xD;
  &#xD;
          -  The study methodology will be reviewed and approved by the faculty research ethical&#xD;
             committee.&#xD;
  &#xD;
          -  Guardians of children will be asked to sign an informed consent in simple Arabic&#xD;
             language before being enrolled in this study. The parents will be assured about&#xD;
             confidentiality of all the collected data and were informed that their child has the&#xD;
             right to withdraw at any given point during treatment without having to provide reasons&#xD;
             for withdrawal.&#xD;
  &#xD;
          -  Children also will fill a simplified assent form.&#xD;
  &#xD;
        Sample Size:&#xD;
  &#xD;
        Sample size estimation was based on testing the null hypothesis that there is no difference&#xD;
        between the clinical success rates of the two materials by setting α error of 5%, power of&#xD;
        80%, and allocation ratio 1:1. Results from previous studies suggested that the one-year&#xD;
        clinical success rate of EQUIA Forte™ in class II restorations in primary molars was 74.4%&#xD;
        (24) , while that for Beautifil flow plus x was estimated to be 94.1% based upon the findings&#xD;
        of a previous study regarding Giomer in class II cavities. Based on this, the needed sample&#xD;
        is 53 primary molars per group. Considering 15% drop-out rate, the needed sample size was&#xD;
        increased to 62 molars per group. Sample size calculation was performed using G*Power&#xD;
        software version 3.1.9.4 for MS Windows Study Population A total of 124 primary molars&#xD;
        fulfilling the eligibility criteria will be restored in eligible participants, with one of&#xD;
        the two tested restorative materials.&#xD;
  &#xD;
        Study grouping:&#xD;
  &#xD;
        The study will include two groups:&#xD;
  &#xD;
        Group I (experimental): 62 primary molars will be restored with flowable Giomer beautifil&#xD;
        flow plus x Group II (comparator): 62 primary molars will be restored with high-viscosity&#xD;
        glass ionomer cement (EQUIA Forte)&#xD;
  &#xD;
        Randomization and blinding:&#xD;
  &#xD;
        Randomization will be performed using the Computer generated random number table to ensure&#xD;
        that each primary molar had an equal chance of being assigned to either the glass ionomer&#xD;
        group or the giomer group. Randomization will be done by tooth such that participants with&#xD;
        multiple eligible carious primary molars were allowed to draw a corresponding number of&#xD;
        cards. This trial will be double-blinded such that all participants, the clinical evaluator&#xD;
        and the data analyst will be blinded to the type of the applied restorative materials in all&#xD;
        periods of the study.&#xD;
  &#xD;
        Allocation concealment:&#xD;
  &#xD;
        The randomization groups will be written on a paper and each of the papers will be numbered&#xD;
        and will be individually packed by another person than the investigator in an opaque envelope&#xD;
        after folding each paper eight folds. All participants will be asked to select an opaque&#xD;
        sealed envelope for each of their carious primary molars to avoid allocation bias. The&#xD;
        numbers in the envelopes determined the group assigned for each molar. The investigator will&#xD;
        open the sealed envelope after the cavity preparation and then assigns the treatment group&#xD;
        accordingly.&#xD;
  &#xD;
        Implementation:&#xD;
  &#xD;
        A. Sequence generation will be done by a trial independent subject. B. Recruitment and&#xD;
        screening of participants will be done by the main investigator, while enrolling of primary&#xD;
        molars for the trial will be decided by two calibrated dentists.&#xD;
  &#xD;
        Participants and assessors will be blinded at baseline and follow up. The primary&#xD;
        investigator will not be blinded. C. Envelops will be kept with a trial independent subject&#xD;
        and the allocated treatment will be revealed after cavity preparation&#xD;
  &#xD;
        Study population:&#xD;
  &#xD;
        Patients attending the Department of Pediatric Dentistry and dental public health, Faculty of&#xD;
        Dentistry, at Ain Shams University for routine dental care will be examined clinically and&#xD;
        radiographically with bite-wing radiography. Patients will be assessed for eligibility for&#xD;
        participation.&#xD;
  &#xD;
        Study Procedure&#xD;
  &#xD;
        A detailed case history will be recorded, and an oral examination will be done. Oral&#xD;
        prophylaxis will be performed to all the study children before the restorative treatment. A&#xD;
        total of 124 primary molars (first/second, maxillary/mandibular) with carious lesions that&#xD;
        indicated for restorative treatment will be selected by specified inclusion criteria. Based&#xD;
        on the type of restorative material, the teeth will be randomly allocated to two groups (n =&#xD;
        62 in each group) Initial bite-wing radiographs of the teeth to be treated will be taken&#xD;
        before the treatment.&#xD;
  &#xD;
        Local anesthesia will be applied. Cavity preparations will be performed using diamond burs at&#xD;
        high speed with water-cooling. Hand instruments and slow-speed tungsten carbide burs were&#xD;
        used to remove the caries. Conservative cavity design will be used and beveling will not&#xD;
        applied to the cavity walls to avoid unnecessary loss of hard dental tissue. The outline&#xD;
        shape of the cavity will be limited to the removal of caries lesion. Any additional retention&#xD;
        will not be prepared. The cavity will be rinsed and then dried with cotton pellets. A metal&#xD;
        matrix band and wedges will be applied. Cotton rolls and a saliva ejector will be used for&#xD;
        isolation.&#xD;
  &#xD;
        Group 1 Giomer; Beautifil flow plus x After caries tissue removal, the cavity will be washed&#xD;
        by rubbing wet cotton pellets against its walls to remove debris and remnants of decayed&#xD;
        tissue removal. In the presence of the adjacent tooth, a matrix band and a wooden wedge were&#xD;
        placed to adapt the restoration. A thin layer of the one-step self-etch adhesive BeautiBond&#xD;
        (Shofu Inc) will be applied with a micro applicator and light cured for 10 s. The operator&#xD;
        will place the Beautifil-flow plus x in increments creating the desired shape. Each increment&#xD;
        will be light-cured for 20 s at each restoration surface. The composite will be used in&#xD;
        increments up to 2 mm. An articulation paper will be used to check if there is any&#xD;
        interference.&#xD;
  &#xD;
        Group 2 Glass-hybrid-added HVGIC; Equia Forte:&#xD;
  &#xD;
        The cavity will be conditioned with a poly- acrylic acid 'dentin conditioner' (EQUIA GC,&#xD;
        JAPAN) which will be left for 15 seconds according to the manufacturer instructions. The&#xD;
        conditioner will later be washed with a water spray, and then rinsing water will be blotted&#xD;
        with a dry cotton pellet, leaving a moist surface. Each capsule of high viscous glass ionomer&#xD;
        cement will be mixed for 10 seconds using amalgamator according to the manufacturer's&#xD;
        instructions then packed into the prepared cavity with a carver and ball burnisher. Any&#xD;
        excess material will be removed using a carver. Finally, a thin layer of the Equia Forte Coat&#xD;
        ® (GC Corp) will be applied with a micro applicator and then light-cured for 20 s. An&#xD;
        articulation paper will be used to check if the restoration caused any occlusal interference.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">December 30, 2022</start_date>
    <completion_date type="Anticipated">June 2024</completion_date>
    <primary_completion_date type="Anticipated">June 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>The clinical performance of Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo, Japan) in restoring class II cavities of primary molars</measure>
      <time_frame>12 months</time_frame>
      <description>The restorations will be evaluated using the FDI criteria having esthetic, functional, and biological properties</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The effect of different independent variables on the treatment outcome of the experimental restorative materials.</measure>
      <time_frame>12 months</time_frame>
      <description>assessment of the effect of different variables such as the age of the patient and the properties of the tooth on the restoration survival</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">124</enrollment>
    <condition>Dental Caries Class II</condition>
    <arm_group>
      <arm_group_label>Flowable Giomer Beautifil flow plus x</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>injectable flowable restorative material</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Glass-hybrid-added HVGIC Equia Forte</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Glass-hybrid-added Highly viscous glass ionomer cement</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>restoration of proximal cavities of primary molars with flowable giomer</intervention_name>
      <description>removal of proximal caries of primary molars and restoration of the cavities prepared by beautifil flow plus x</description>
      <arm_group_label>Flowable Giomer Beautifil flow plus x</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>restoration of proximal cavities of primary molars with highly viscous glass ionomer cement</intervention_name>
      <description>removal of proximal caries of primary molars and restoration of the cavities prepared by equia forte</description>
      <arm_group_label>Glass-hybrid-added HVGIC Equia Forte</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          inclusion criteria of study participants:&#xD;
  &#xD;
            1. 4 to 8 years old medically free children.&#xD;
  &#xD;
            2. Cooperative children classified as class 3 or 4 based on Frankel et al. classification&#xD;
  &#xD;
            3. Children who had at least one active dentinal carious lesion on proximal surface of&#xD;
               primary molars&#xD;
  &#xD;
          inclusion criteria of teeth:&#xD;
  &#xD;
            1. Primary molars with active dentinal carious lesion on their proximal surface score 4,&#xD;
               5 using ICDAS.&#xD;
  &#xD;
            2. Primary molars with proximal carious lesion extended to outer and middle third of&#xD;
               dentin scored D1and D2 that will be detected by bitewing radiograph.&#xD;
  &#xD;
            3. Simple or compound class II cavities be present&#xD;
  &#xD;
            4. The antagonist and the adjacent tooth should be present&#xD;
  &#xD;
            5. Primary molar should have at least 2/3 of the root present&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          exclusion criteria of study participants&#xD;
  &#xD;
            1. Refusal of the parents to sign the informed consent&#xD;
  &#xD;
            2. Presence of deep bite or any pictures of malocclusion and any parafunctional habits.&#xD;
  &#xD;
          exclusion criteria of teeth&#xD;
  &#xD;
            1. Presence of any unprovoked pain, pulp exposure,clinical swelling, abscess or fistula.&#xD;
  &#xD;
            2. Presence of any physiological or pathological mobility.&#xD;
  &#xD;
            3. Very deep subgingival cavities&#xD;
  &#xD;
            4. Teeth with congenitally missing successor&#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>
    <overall_official>
      <last_name>Sarah Emad</last_name>
      <role>Principal Investigator</role>
      <affiliation>faculty of dentistry ain shams university</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sarah Emad</last_name>
      <phone>01005699595</phone>
      <email>dent.sarah.emad@gmail.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Faculty of dentistry ain shams university</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Sarah E Alieldin</last_name>
        <phone>01005699595</phone>
        <email>Dent.sarah.emad@gmail.com</email>
      </contact>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 11, 2023</study_first_submitted>
    <study_first_submitted_qc>August 11, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>September 8, 2023</last_update_submitted>
    <last_update_submitted_qc>September 8, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Ain Shams University</investigator_affiliation>
      <investigator_full_name>Sarah Emad Ali El-Din</investigator_full_name>
      <investigator_title>Assistant lecturer at the Pediatric Dentistry and Dental Public Health Department-Faculty of Dentistry</investigator_title>
    </responsible_party>
    <keyword>proximal caries</keyword>
    <keyword>primary molars</keyword>
    <keyword>flowable giomer</keyword>
    <keyword>equia forte</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Caries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- 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/NCT06000085
  org study id: PED 22-4D
  nct id: NCT06000085
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  The aim of the present study is to assess Flowable Giomer Beautifil Flow Plus X (Shofu Dental
        Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo,
  
        Japan) in class II cavities of primary molars regarding the following objectives:
  
        The primary objective To evaluate and compare the clinical performance of Flowable Giomer
        Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia
        Forte (GC Corporation, Tokyo, Japan) in restoring class II cavities of primary molars after
        3,6, and 12 months. The secondary objective To assess the effect of different independent
        variables on the treatment outcome of the experimental restorative materials.
  
        Research question:
  
        Is there a difference in the clinical performance between flowable giomers and highly viscous
        glass ionomer in restoring class II cavities of primary molars?
  
        Null Hypothesis There is no difference in the clinical performance between Flowable Giomer
        Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia
        Forte (GC Corporation, Tokyo, Japan) after one year of follow up.
  Study design:
  
        The study will be two parallel-arm, double blinded randomized, controlled clinical trial with
        an equal allocation ratio.
  
        Study Setting:
  
        The study will be conducted at Pediatric dentistry and Dental Public Health Department,
        Faculty of Dentistry, Ain Shams University.
  
        Ethical Considerations:
  
          -  The study methodology will be reviewed and approved by the faculty research ethical
             committee.
  
          -  Guardians of children will be asked to sign an informed consent in simple Arabic
             language before being enrolled in this study. The parents will be assured about
             confidentiality of all the collected data and were informed that their child has the
             right to withdraw at any given point during treatment without having to provide reasons
             for withdrawal.
  
          -  Children also will fill a simplified assent form.
  
        Sample Size:
  
        Sample size estimation was based on testing the null hypothesis that there is no difference
        between the clinical success rates of the two materials by setting α error of 5%, power of
        80%, and allocation ratio 1:1. Results from previous studies suggested that the one-year
        clinical success rate of EQUIA Forte™ in class II restorations in primary molars was 74.4%
        (24) , while that for Beautifil flow plus x was estimated to be 94.1% based upon the findings
        of a previous study regarding Giomer in class II cavities. Based on this, the needed sample
        is 53 primary molars per group. Considering 15% drop-out rate, the needed sample size was
        increased to 62 molars per group. Sample size calculation was performed using G*Power
        software version 3.1.9.4 for MS Windows Study Population A total of 124 primary molars
        fulfilling the eligibility criteria will be restored in eligible participants, with one of
        the two tested restorative materials.
  
        Study grouping:
  
        The study will include two groups:
  
        Group I (experimental): 62 primary molars will be restored with flowable Giomer beautifil
        flow plus x Group II (comparator): 62 primary molars will be restored with high-viscosity
        glass ionomer cement (EQUIA Forte)
  
        Randomization and blinding:
  
        Randomization will be performed using the Computer generated random number table to ensure
        that each primary molar had an equal chance of being assigned to either the glass ionomer
        group or the giomer group. Randomization will be done by tooth such that participants with
        multiple eligible carious primary molars were allowed to draw a corresponding number of
        cards. This trial will be double-blinded such that all participants, the clinical evaluator
        and the data analyst will be blinded to the type of the applied restorative materials in all
        periods of the study.
  
        Allocation concealment:
  
        The randomization groups will be written on a paper and each of the papers will be numbered
        and will be individually packed by another person than the investigator in an opaque envelope
        after folding each paper eight folds. All participants will be asked to select an opaque
        sealed envelope for each of their carious primary molars to avoid allocation bias. The
        numbers in the envelopes determined the group assigned for each molar. The investigator will
        open the sealed envelope after the cavity preparation and then assigns the treatment group
        accordingly.
  
        Implementation:
  
        A. Sequence generation will be done by a trial independent subject. B. Recruitment and
        screening of participants will be done by the main investigator, while enrolling of primary
        molars for the trial will be decided by two calibrated dentists.
  
        Participants and assessors will be blinded at baseline and follow up. The primary
        investigator will not be blinded. C. Envelops will be kept with a trial independent subject
        and the allocated treatment will be revealed after cavity preparation
  
        Study population:
  
        Patients attending the Department of Pediatric Dentistry and dental public health, Faculty of
        Dentistry, at Ain Shams University for routine dental care will be examined clinically and
        radiographically with bite-wing radiography. Patients will be assessed for eligibility for
        participation.
  
        Study Procedure
  
        A detailed case history will be recorded, and an oral examination will be done. Oral
        prophylaxis will be performed to all the study children before the restorative treatment. A
        total of 124 primary molars (first/second, maxillary/mandibular) with carious lesions that
        indicated for restorative treatment will be selected by specified inclusion criteria. Based
        on the type of restorative material, the teeth will be randomly allocated to two groups (n =
        62 in each group) Initial bite-wing radiographs of the teeth to be treated will be taken
        before the treatment.
  
        Local anesthesia will be applied. Cavity preparations will be performed using diamond burs at
        high speed with water-cooling. Hand instruments and slow-speed tungsten carbide burs were
        used to remove the caries. Conservative cavity design will be used and beveling will not
        applied to the cavity walls to avoid unnecessary loss of hard dental tissue. The outline
        shape of the cavity will be limited to the removal of caries lesion. Any additional retention
        will not be prepared. The cavity will be rinsed and then dried with cotton pellets. A metal
        matrix band and wedges will be applied. Cotton rolls and a saliva ejector will be used for
        isolation.
  
        Group 1 Giomer; Beautifil flow plus x After caries tissue removal, the cavity will be washed
        by rubbing wet cotton pellets against its walls to remove debris and remnants of decayed
        tissue removal. In the presence of the adjacent tooth, a matrix band and a wooden wedge were
        placed to adapt the restoration. A thin layer of the one-step self-etch adhesive BeautiBond
        (Shofu Inc) will be applied with a micro applicator and light cured for 10 s. The operator
        will place the Beautifil-flow plus x in increments creating the desired shape. Each increment
        will be light-cured for 20 s at each restoration surface. The composite will be used in
        increments up to 2 mm. An articulation paper will be used to check if there is any
        interference.
  
        Group 2 Glass-hybrid-added HVGIC; Equia Forte:
  
        The cavity will be conditioned with a poly- acrylic acid 'dentin conditioner' (EQUIA GC,
        JAPAN) which will be left for 15 seconds according to the manufacturer instructions. The
        conditioner will later be washed with a water spray, and then rinsing water will be blotted
        with a dry cotton pellet, leaving a moist surface. Each capsule of high viscous glass ionomer
        cement will be mixed for 10 seconds using amalgamator according to the manufacturer's
        instructions then packed into the prepared cavity with a carver and ball burnisher. Any
        excess material will be removed using a carver. Finally, a thin layer of the Equia Forte Coat
        ® (GC Corp) will be applied with a micro applicator and then light-cured for 20 s. An
        articulation paper will be used to check if the restoration caused any occlusal interference.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Triple (Participant, Investigator, Outcomes Assessor)
  measure: The clinical performance of Flowable Giomer Beautifil Flow Plus X (Shofu Dental Corporation, Japan) and Glass-hybrid-added HVGIC, Equia Forte (GC Corporation, Tokyo, Japan) in restoring class II cavities of primary molars
  time frame: 12 months
  description: The restorations will be evaluated using the FDI criteria having esthetic, functional, and biological properties
  measure: The effect of different independent variables on the treatment outcome of the experimental restorative materials.
  time frame: 12 months
  description: assessment of the effect of different variables such as the age of the patient and the properties of the tooth on the restoration survival
  arm group label: Flowable Giomer Beautifil flow plus x
  arm group type: Experimental
  description: injectable flowable restorative material
  arm group label: Glass-hybrid-added HVGIC Equia Forte
  arm group type: Active Comparator
  description: Glass-hybrid-added Highly viscous glass ionomer cement
  intervention type: Procedure
  intervention name: restoration of proximal cavities of primary molars with flowable giomer
  description: removal of proximal caries of primary molars and restoration of the cavities prepared by beautifil flow plus x
  arm group label: Flowable Giomer Beautifil flow plus x
  intervention type: Procedure
  intervention name: restoration of proximal cavities of primary molars with highly viscous glass ionomer cement
  description: removal of proximal caries of primary molars and restoration of the cavities prepared by equia forte
  arm group label: Glass-hybrid-added HVGIC Equia Forte
  criteria: 
  gender: All
  minimum age: 4 Years
  maximum age: 8 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Sarah Emad
  role: Principal Investigator
  affiliation: faculty of dentistry ain shams university
  last name: Sarah Emad
  phone: 01005699595
  email: dent.sarah.emad@gmail.com
  facility: 
  status: Recruiting
  contact: 
  country: Egypt
  responsible party type: Principal Investigator
  investigator affiliation: Ain Shams University
  investigator full name: Sarah Emad Ali El-Din
  investigator title: Assistant lecturer at the Pediatric Dentistry and Dental Public Health Department-Faculty of Dentistry
  mesh term: Dental Caries
  sharing ipd: No