<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/NCT03771196</url>
  </required_header>
  <id_info>
    <org_study_id>7/12/2018</org_study_id>
    <nct_id>NCT03771196</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Bioactive Restorative vs. RMGI in Class V: A Randomized Control Trial</brief_title>
  <official_title>Clinical Evaluation of Bioactive Restorative vs. RMGI in Class V: A Randomized Control 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>Yes</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>
      Clinical performance of bioactive restorative material versus Resin Modifeid Glass Ionoer&#xD;
      (RMGI) in class V o will be evaluated over 12 months using United State Public Health&#xD;
      Criteria (USHPS) clinical criteria for the evaluation of direct and indirect restorations&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Recent developments in the province of material sciences, some novel materials require direct&#xD;
      association with oral environment for renewal, recharging or enhancing of the constituents of&#xD;
      the restoration to improve marginal integrity to decrease bacterial microleakage. Physical&#xD;
      and chemical properties of dental restorations have been progressed such that individual&#xD;
      components may exert a bioactive role in the prevention, remineralization, and restoration of&#xD;
      active carious lesions.Fluoride containing restorative materials recently gained great&#xD;
      attention. Fluoride decreases caries activity by being a bacteriostatic and by decreasing the&#xD;
      solubility of enamel and dentin through its integration into tooth tissue to form&#xD;
      fluoroapatite. Moreover, it aids to remineralize defected tooth structure after&#xD;
      demineralization. conventional GICs and RMGICs are have high fluoride release and could be&#xD;
      specified clinically to repair decayed non-biting areas in high caries risk patients.To&#xD;
      enhance the mechanical properties of GIs, their constituents have been modified&#xD;
      Comparatively, resin-modified GIs (RMGIs) with a longer working time, faster setting, higher&#xD;
      early strength, and improved appearance and translucency. Unfortunately, the RMGI's&#xD;
      mechanical properties of are different to resin composites. progressive development of&#xD;
      material sciences has resulted in the introduction of bioactive restorative materials. These&#xD;
      materials can activate a tissue repair mechanism for or synthesis and elicit a response from&#xD;
      teeth and surrounding environment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">March 2019</start_date>
  <completion_date type="Anticipated">December 2022</completion_date>
  <primary_completion_date type="Anticipated">August 2022</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, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the clinical performance using United State Public Health Service (USHPS)</measure>
    <time_frame>Change from the baseline at 6 months and12 months</time_frame>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Dental Restoration Failure</condition>
  <arm_group>
    <arm_group_label>Bioactive-Restorative material</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Activa Bioactive-Restorative is an enhanced resin modified glass ionomer (RMGI) with an ionic resin matrix, a shock-absorbing resin component, and bioactive fillers that mimic the physical and chemical properties of natural teeth.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resin Modified Glass Ionomer (RMGI)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Fuji II Lc, fluoride-releasing restorative system that combines fluoride release of glass ionomer cement and acceptable esthetics a wear-resistant, self-adhesive, light-cured resin coating.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Bioactive Restorative Material</intervention_name>
    <description>enhanced RMGIs with an ionic resin matrix, a shock-absorbing resin component, and bioactive fillers that mimic the physical and chemical properties of natural teeth</description>
    <arm_group_label>Bioactive-Restorative material</arm_group_label>
    <other_name>Activa Bioactive RestorActiva Bioactive Restorativeative</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resin-modified glass ionomer</intervention_name>
    <description>Enhanced glass ionomer with acceptable mechanical properties and esthtic properties</description>
    <arm_group_label>Resin Modified Glass Ionomer (RMGI)</arm_group_label>
    <other_name>Fuji II lc</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Cervical Class V carious lesions.&#xD;
&#xD;
          -  Age 18-50 years.&#xD;
&#xD;
          -  Co-operative patients approving to participate in the study.&#xD;
&#xD;
          -  Pulp asymptomatic vital carious posterior teeth.&#xD;
&#xD;
          -  Presence of favorable occlusion and teeth are in normal contact with the adjacent&#xD;
             teeth.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systemic disease or severe medical complications.&#xD;
&#xD;
          -  Allergic history concerning methacrylates&#xD;
&#xD;
          -  Rampant caries&#xD;
&#xD;
          -  Pregnancy&#xD;
&#xD;
          -  Disabilities&#xD;
&#xD;
          -  Heavy smoking; xerostomia&#xD;
&#xD;
          -  Lack of compliance&#xD;
&#xD;
          -  Evidence of severe bruxism, clenching, or temporomandibular joint disorders or bizarre&#xD;
             habits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Yehia H. Yehia</last_name>
    <phone>+20 01225337792</phone>
    <email>yehiahafez@dentistry.cu.edu.eg</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Amira F. El-Zoughbi</last_name>
    <email>amfzh52@yahoo.com</email>
  </overall_contact_backup>
  <reference>
    <citation>o ALKHUDHAIRY FI &amp; ZH, A. 2016. Comparison of Shear Bond Strength and Microleakage of Various Bulk-fill Bioactive Dentin substitutes: An in vitro study. J Contemp Dent Pract, 17. o B. RANJBAR OMIDI, F. F. N., H. DEHGHAN, P. TAMIZ, M. MOHAMMADI SAVADROODBARI, AND R. JABBARIAN, 2018. Microleakage of an Enhanced Resin-Modified Glass Ionomer Restorative Material in Primary Molars. Journal of Dentistry of Tehran University of Medical Sciences (jdt), 15. o BANSAL, R., BURGESS, J. &amp; LAWSON, N. C. 2016. Wear of an enhanced resin-modified glass-ionomer restorative material. Am J Dent, 29, 171-4. o CROLL, T. P., BERG, J. H. &amp; DONLY, K. J. 2015. Dental repair material: a resin-modified glass-ionomer bioactive ionic resin-based composite. Compend Contin Educ Dent, 36, 60-5. o GAROUSHI, S., VALLITTU, P. K. &amp; LASSILA, L. 2018. Characterization of fluoride releasing restorative dental materials. Dent Mater J, 37, 293-300. o HICKEL, R., PESCHKE, A., TYAS, M., MJOR, I., BAYNE, S., PETERS, M., HILLER, K. A., RANDALL, R., VANHERLE, G. &amp; HEINTZE, S. D. 2010. FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. J Adhes Dent, 12, 259-72. o MICHOU, S., LARSEN, L., BENETTI, A. R. &amp; PEUTZFELDT, A. 2018. Adhesion and marginal integrity of bioactive restorative materials. Dental Materials, 34, e11. o NAGI, S. M., MOHARAM, L. M. &amp; EL HOSHY, A. Z. 2018. Fluoride release and recharge of enhanced resin modified glass ionomer at different time intervals. Future Dental Journal. o NEMATOLLAHI, H., BAGHERIAN, A., GHAZVINI, K., ESMAILY, H. &amp; MEHR, M. A. 2017. Microbial microleakage assessment of class V cavities restored with different materials and techniques: A laboratory study. Dental research journal, 14, 344-350. o OWENS, B. M., PHEBUS, J. G. &amp; JOHNSON, W. W. 2018. Evaluation of the marginal integrity of a bioactive restorative material. Gen Dent, 66, 32-36. o PAMEIJER, C. H., GARCIA-GODOY, F., MORROW, B. R. &amp; JEFFERIES, S. R. 2015. Flexural strength and flexural_fatigue. J Clin Dent, 26, 5. o PERDIGAO, J., DUTRA-CORREA, M., SARACENI, S. H., CIARAMICOLI, M. T. &amp; KIYAN, V. H. 2012. Randomized clinical trial of two resin-modified glass ionomer materials: 1-year results. Oper Dent, 37, 591-601.2016. Guideline on Restorative Dentistry. Pediatr Dent, 38, 250-262.</citation>
  </reference>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 7, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 11, 2018</study_first_posted>
  <last_update_submitted>December 7, 2018</last_update_submitted>
  <last_update_submitted_qc>December 7, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 11, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Yehia Hafez Yehia</investigator_full_name>
    <investigator_title>Yehia Hafez Yehia</investigator_title>
  </responsible_party>
  <keyword>Bioactive Restorative Material</keyword>
  <keyword>ACTIVA Restorative</keyword>
  <keyword>Resin Modified Glass Ionomer (RMGI)</keyword>
  <keyword>class V</keyword>
  <keyword>Clinical perfomance</keyword>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_info_type>Study Protocol</ipd_info_type>
  </patient_data>
  <!-- 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/NCT03771196
org study id: 7/12/2018
nct id: NCT03771196
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Clinical performance of bioactive restorative material versus Resin Modifeid Glass Ionoer
      (RMGI) in class V o will be evaluated over 12 months using United State Public Health
      Criteria (USHPS) clinical criteria for the evaluation of direct and indirect restorations
Recent developments in the province of material sciences, some novel materials require direct
      association with oral environment for renewal, recharging or enhancing of the constituents of
      the restoration to improve marginal integrity to decrease bacterial microleakage. Physical
      and chemical properties of dental restorations have been progressed such that individual
      components may exert a bioactive role in the prevention, remineralization, and restoration of
      active carious lesions.Fluoride containing restorative materials recently gained great
      attention. Fluoride decreases caries activity by being a bacteriostatic and by decreasing the
      solubility of enamel and dentin through its integration into tooth tissue to form
      fluoroapatite. Moreover, it aids to remineralize defected tooth structure after
      demineralization. conventional GICs and RMGICs are have high fluoride release and could be
      specified clinically to repair decayed non-biting areas in high caries risk patients.To
      enhance the mechanical properties of GIs, their constituents have been modified
      Comparatively, resin-modified GIs (RMGIs) with a longer working time, faster setting, higher
      early strength, and improved appearance and translucency. Unfortunately, the RMGI's
      mechanical properties of are different to resin composites. progressive development of
      material sciences has resulted in the introduction of bioactive restorative materials. These
      materials can activate a tissue repair mechanism for or synthesis and elicit a response from
      teeth and surrounding environment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Change in the clinical performance using United State Public Health Service (USHPS)
time frame: Change from the baseline at 6 months and12 months
arm group label: Bioactive-Restorative material
arm group type: Experimental
description: Activa Bioactive-Restorative is an enhanced resin modified glass ionomer (RMGI) with an ionic resin matrix, a shock-absorbing resin component, and bioactive fillers that mimic the physical and chemical properties of natural teeth.
arm group label: Resin Modified Glass Ionomer (RMGI)
arm group type: Active Comparator
description: Fuji II Lc, fluoride-releasing restorative system that combines fluoride release of glass ionomer cement and acceptable esthetics a wear-resistant, self-adhesive, light-cured resin coating.
intervention type: Other
intervention name: Bioactive Restorative Material
description: enhanced RMGIs with an ionic resin matrix, a shock-absorbing resin component, and bioactive fillers that mimic the physical and chemical properties of natural teeth
arm group label: Bioactive-Restorative material
other name: Activa Bioactive RestorActiva Bioactive Restorativeative
intervention type: Other
intervention name: Resin-modified glass ionomer
description: Enhanced glass ionomer with acceptable mechanical properties and esthtic properties
arm group label: Resin Modified Glass Ionomer (RMGI)
other name: Fuji II lc
criteria: 
gender: All
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Yehia H. Yehia
phone: +20 01225337792
email: yehiahafez@dentistry.cu.edu.eg
last name: Amira F. El-Zoughbi
email: amfzh52@yahoo.com
citation: o ALKHUDHAIRY FI & ZH, A. 2016. Comparison of Shear Bond Strength and Microleakage of Various Bulk-fill Bioactive Dentin substitutes: An in vitro study. J Contemp Dent Pract, 17. o B. RANJBAR OMIDI, F. F. N., H. DEHGHAN, P. TAMIZ, M. MOHAMMADI SAVADROODBARI, AND R. JABBARIAN, 2018. Microleakage of an Enhanced Resin-Modified Glass Ionomer Restorative Material in Primary Molars. Journal of Dentistry of Tehran University of Medical Sciences (jdt), 15. o BANSAL, R., BURGESS, J. & LAWSON, N. C. 2016. Wear of an enhanced resin-modified glass-ionomer restorative material. Am J Dent, 29, 171-4. o CROLL, T. P., BERG, J. H. & DONLY, K. J. 2015. Dental repair material: a resin-modified glass-ionomer bioactive ionic resin-based composite. Compend Contin Educ Dent, 36, 60-5. o GAROUSHI, S., VALLITTU, P. K. & LASSILA, L. 2018. Characterization of fluoride releasing restorative dental materials. Dent Mater J, 37, 293-300. o HICKEL, R., PESCHKE, A., TYAS, M., MJOR, I., BAYNE, S., PETERS, M., HILLER, K. A., RANDALL, R., VANHERLE, G. & HEINTZE, S. D. 2010. FDI World Dental Federation - clinical criteria for the evaluation of direct and indirect restorations. Update and clinical examples. J Adhes Dent, 12, 259-72. o MICHOU, S., LARSEN, L., BENETTI, A. R. & PEUTZFELDT, A. 2018. Adhesion and marginal integrity of bioactive restorative materials. Dental Materials, 34, e11. o NAGI, S. M., MOHARAM, L. M. & EL HOSHY, A. Z. 2018. Fluoride release and recharge of enhanced resin modified glass ionomer at different time intervals. Future Dental Journal. o NEMATOLLAHI, H., BAGHERIAN, A., GHAZVINI, K., ESMAILY, H. & MEHR, M. A. 2017. Microbial microleakage assessment of class V cavities restored with different materials and techniques: A laboratory study. Dental research journal, 14, 344-350. o OWENS, B. M., PHEBUS, J. G. & JOHNSON, W. W. 2018. Evaluation of the marginal integrity of a bioactive restorative material. Gen Dent, 66, 32-36. o PAMEIJER, C. H., GARCIA-GODOY, F., MORROW, B. R. & JEFFERIES, S. R. 2015. Flexural strength and flexural_fatigue. J Clin Dent, 26, 5. o PERDIGAO, J., DUTRA-CORREA, M., SARACENI, S. H., CIARAMICOLI, M. T. & KIYAN, V. H. 2012. Randomized clinical trial of two resin-modified glass ionomer materials: 1-year results. Oper Dent, 37, 591-601.2016. Guideline on Restorative Dentistry. Pediatr Dent, 38, 250-262.
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Yehia Hafez Yehia
investigator title: Yehia Hafez Yehia
sharing ipd: Yes
ipd info type: Study Protocol