<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/NCT03030690</url>
  </required_header>
  <id_info>
    <org_study_id>070-16</org_study_id>
    <nct_id>NCT03030690</nct_id>
  </id_info>
  <brief_title>A Clinical Assessment of Glass Carbomer Cement</brief_title>
  <official_title>A Clinical Assessment of Class II Glass Carbomer Cement Restorations Compared to Resin Modified Glass Ionomer Cement and Composite Resin Restorations in Primary Molars.</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>King Abdulaziz University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>King Abdulaziz University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      This study will evaluate the clinical performance of glass carbomer cement restorations in&#xD;
      restoring proximal lesions in primary molars compared to that of resin modified glass ionomer&#xD;
      cement and composite resin restorations. Teeth will be randomly assigned to one of the three&#xD;
      restoration groups and the restorations will be evaluated clinically and radiographically&#xD;
      every six months.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Glass Carbomer is a monomer free; carbomised nano-glass restorative cement developed from&#xD;
      traditional glass ionomer cement (GIC) and contains nano-sized powder particles of&#xD;
      hydroxyapatite and fluorapatite. These materials claim to have improved mechanical properties&#xD;
      and better bonding to dentin, in addition to continues fluoride release.&#xD;
&#xD;
      The study is a randomized controlled clinical trial where teeth will be randomly assigned to&#xD;
      one of the three restoration groups.&#xD;
&#xD;
      Following medical and dental history, bilateral bitewing radiographs will be taken for each&#xD;
      patient to assess the presence of proximal lesions. Suitable teeth will then be randomly&#xD;
      assigned to one of the restoration groups. A single operator using local anesthesia and&#xD;
      rubber dam isolation will then prepare standardized Class II cavities and place the&#xD;
      designated restorations according to the manufacturer's instructions.&#xD;
&#xD;
      The quality of the 3 types of restorations will be clinically evaluated at baseline and every&#xD;
      six months for color match, marginal discoloration, anatomic form, marginal adaptation, and&#xD;
      secondary caries using the criteria described by &quot;Cvar and Ryge&quot; (2005). The evaluation will&#xD;
      be performed by 2 calibrated examiners.&#xD;
&#xD;
      Following placement of the restorations, bitewing radiographs will be taken to evaluate the&#xD;
      restorations and will be repeated every six months for detection of recurrent caries.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 2016</start_date>
  <completion_date type="Actual">January 2018</completion_date>
  <primary_completion_date type="Actual">January 2018</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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>clinical success rate of glass carbomer cement in restoring proximal lesions in primary molars.</measure>
    <time_frame>2 Years</time_frame>
    <description>the clinical success of glass carbomer cement in restoring proximal lesions compared to the success of resin modified glass ionomer cement and composite resin.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">50</enrollment>
  <condition>Dental Caries Class II</condition>
  <arm_group>
    <arm_group_label>Glass Carbomer Cement</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>GCP Glass Fill, Glass Carbomer™Tech, Ridderkerk, Netherlands</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Resin Modified Glass Ionomer Cement</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>GC Fuji II LC Capsule, GC International, Tokyo, Japan</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Composite Resin</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Filtek Z250, 3M ESPE, St Paul, MN, USA</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Glass Carbomer Cement</intervention_name>
    <description>Restoration of proximal lesions in primary molars using glass carbomer cement</description>
    <arm_group_label>Glass Carbomer Cement</arm_group_label>
    <other_name>GCP Glass Fill</other_name>
    <other_name>Hydroxyapatite enhance glass ionomer cement</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Composite Resin</intervention_name>
    <description>Restoration of proximal lesions in primary molars using composite resin.</description>
    <arm_group_label>Composite Resin</arm_group_label>
    <other_name>Filtek Z250</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Resin Modified Glass Ionomer Cement</intervention_name>
    <description>Restoration of proximal lesions in primary molars using resin modified glass ionomer cement</description>
    <arm_group_label>Resin Modified Glass Ionomer Cement</arm_group_label>
    <other_name>GC Fuji II LC Capsule</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  One proximal lesion in a primary molar.&#xD;
&#xD;
          -  Radiographic evidence of caries extending at least into the inner half of the enamel&#xD;
             but not the inner half of dentin.&#xD;
&#xD;
          -  Proximal contact with adjacent healthy or restored teeth.&#xD;
&#xD;
          -  Occlusal contact with opposing healthy or restored teeth.&#xD;
&#xD;
          -  No indication for pulp therapy or other restorative treatment.&#xD;
&#xD;
          -  A predicted survival until exfoliation of 2 years.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Radiographic evidence of caries extending into the inner half of dentin.&#xD;
&#xD;
          -  No proximal contact with adjacent healthy or restored teeth.&#xD;
&#xD;
          -  No occlusal contact with opposing healthy or restored teeth.&#xD;
&#xD;
          -  Tooth indicated for pulp therapy or other restorative treatment.&#xD;
&#xD;
          -  A predicted survival until exfoliation of less than 2 years.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>4 Years</minimum_age>
    <maximum_age>10 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Najlaa Alamoudi, MSc, DSc</last_name>
    <role>Study Chair</role>
    <affiliation>King Abdulaziz University</affiliation>
  </overall_official>
  <link>
    <url>https://www.york.ac.uk/media/crd/crdreport19.pdf</url>
    <description>The longevity of dental restorations: a systematic review. Report 19, NHS Centre for Reviews and Dissemination</description>
  </link>
  <reference>
    <citation>Chen X, Du MQ, Fan MW, Mulder J, Huysmans MC, Frencken JE. Caries-preventive effect of sealants produced with altered glass-ionomer materials, after 2 years. Dent Mater. 2012 May;28(5):554-60. doi: 10.1016/j.dental.2012.01.001. Epub 2012 Jan 31.</citation>
    <PMID>22300651</PMID>
  </reference>
  <reference>
    <citation>Chen X, Du M, Fan M, Mulder J, Huysmans MC, Frencken JE. Effectiveness of two new types of sealants: retention after 2 years. Clin Oral Investig. 2012 Oct;16(5):1443-50. doi: 10.1007/s00784-011-0633-9. Epub 2011 Nov 29.</citation>
    <PMID>22124610</PMID>
  </reference>
  <reference>
    <citation>Cvar JF, Ryge G. Reprint of criteria for the clinical evaluation of dental restorative materials. 1971. Clin Oral Investig. 2005 Dec;9(4):215-32. doi: 10.1007/s00784-005-0018-z. No abstract available.</citation>
    <PMID>16315023</PMID>
  </reference>
  <reference>
    <citation>Gorseta K, Glavina D, Borzabadi-Farahani A, Van Duinen RN, Skrinjaric I, Hill RG, Lynch E. One-year clinical evaluation of a Glass Carbomer fissure sealant, a preliminary study. Eur J Prosthodont Restor Dent. 2014 Jun;22(2):67-71.</citation>
    <PMID>25134364</PMID>
  </reference>
  <reference>
    <citation>Gu YW, Yap AU, Cheang P, Khor KA. Effects of incorporation of HA/ZrO(2) into glass ionomer cement (GIC). Biomaterials. 2005 Mar;26(7):713-20. doi: 10.1016/j.biomaterials.2004.03.019.</citation>
    <PMID>15350775</PMID>
  </reference>
  <reference>
    <citation>Hubel S, Mejare I. Conventional versus resin-modified glass-ionomer cement for Class II restorations in primary molars. A 3-year clinical study. Int J Paediatr Dent. 2003 Jan;13(1):2-8. doi: 10.1046/j.1365-263x.2003.00416.x.</citation>
    <PMID>12542617</PMID>
  </reference>
  <reference>
    <citation>Lucas ME, Arita K, Nishino M. Toughness, bonding and fluoride-release properties of hydroxyapatite-added glass ionomer cement. Biomaterials. 2003 Sep;24(21):3787-94. doi: 10.1016/s0142-9612(03)00260-6.</citation>
    <PMID>12818551</PMID>
  </reference>
  <reference>
    <citation>Lucas ME, Arita K, Nishino M. Strengthening a conventional glass ionomer cement using hydroxyapatite. J Dent Res. 2001;80:711.</citation>
  </reference>
  <reference>
    <citation>Moshaverinia A, Ansari S, Moshaverinia M, Roohpour N, Darr JA, Rehman I. Effects of incorporation of hydroxyapatite and fluoroapatite nanobioceramics into conventional glass ionomer cements (GIC). Acta Biomater. 2008 Mar;4(2):432-40. doi: 10.1016/j.actbio.2007.07.011. Epub 2007 Aug 25.</citation>
    <PMID>17921077</PMID>
  </reference>
  <verification_date>March 2018</verification_date>
  <study_first_submitted>January 21, 2017</study_first_submitted>
  <study_first_submitted_qc>January 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 25, 2017</study_first_posted>
  <last_update_submitted>March 5, 2018</last_update_submitted>
  <last_update_submitted_qc>March 5, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">March 7, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>King Abdulaziz University</investigator_affiliation>
    <investigator_full_name>Sumaya Nouri</investigator_full_name>
    <investigator_title>BDS, M.Sc</investigator_title>
  </responsible_party>
  <keyword>Proximal Dental Caries</keyword>
  <keyword>Glass Carbomer</keyword>
  <keyword>Hydroxyapatite Enhanced Glass Ionomer</keyword>
  <keyword>Primary Teeth</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Dental Caries</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Methamphetamine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </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/NCT03030690
org study id: 070-16
nct id: NCT03030690
lead sponsor: 
has dmc: No
This study will evaluate the clinical performance of glass carbomer cement restorations in
      restoring proximal lesions in primary molars compared to that of resin modified glass ionomer
      cement and composite resin restorations. Teeth will be randomly assigned to one of the three
      restoration groups and the restorations will be evaluated clinically and radiographically
      every six months.
Glass Carbomer is a monomer free; carbomised nano-glass restorative cement developed from
      traditional glass ionomer cement (GIC) and contains nano-sized powder particles of
      hydroxyapatite and fluorapatite. These materials claim to have improved mechanical properties
      and better bonding to dentin, in addition to continues fluoride release.

      The study is a randomized controlled clinical trial where teeth will be randomly assigned to
      one of the three restoration groups.

      Following medical and dental history, bilateral bitewing radiographs will be taken for each
      patient to assess the presence of proximal lesions. Suitable teeth will then be randomly
      assigned to one of the restoration groups. A single operator using local anesthesia and
      rubber dam isolation will then prepare standardized Class II cavities and place the
      designated restorations according to the manufacturer's instructions.

      The quality of the 3 types of restorations will be clinically evaluated at baseline and every
      six months for color match, marginal discoloration, anatomic form, marginal adaptation, and
      secondary caries using the criteria described by "Cvar and Ryge" (2005). The evaluation will
      be performed by 2 calibrated examiners.

      Following placement of the restorations, bitewing radiographs will be taken to evaluate the
      restorations and will be repeated every six months for detection of recurrent caries.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: clinical success rate of glass carbomer cement in restoring proximal lesions in primary molars.
time frame: 2 Years
description: the clinical success of glass carbomer cement in restoring proximal lesions compared to the success of resin modified glass ionomer cement and composite resin.
arm group label: Glass Carbomer Cement
arm group type: Experimental
description: GCP Glass Fill, Glass Carbomer™Tech, Ridderkerk, Netherlands
arm group label: Resin Modified Glass Ionomer Cement
arm group type: Active Comparator
description: GC Fuji II LC Capsule, GC International, Tokyo, Japan
arm group label: Composite Resin
arm group type: Active Comparator
description: Filtek Z250, 3M ESPE, St Paul, MN, USA
intervention type: Other
intervention name: Glass Carbomer Cement
description: Restoration of proximal lesions in primary molars using glass carbomer cement
arm group label: Glass Carbomer Cement
other name: GCP Glass Fill
other name: Hydroxyapatite enhance glass ionomer cement
intervention type: Other
intervention name: Composite Resin
description: Restoration of proximal lesions in primary molars using composite resin.
arm group label: Composite Resin
other name: Filtek Z250
intervention type: Other
intervention name: Resin Modified Glass Ionomer Cement
description: Restoration of proximal lesions in primary molars using resin modified glass ionomer cement
arm group label: Resin Modified Glass Ionomer Cement
other name: GC Fuji II LC Capsule
criteria: 
gender: All
minimum age: 4 Years
maximum age: 10 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Najlaa Alamoudi, MSc, DSc
role: Study Chair
affiliation: King Abdulaziz University
url: https://www.york.ac.uk/media/crd/crdreport19.pdf
description: The longevity of dental restorations: a systematic review. Report 19, NHS Centre for Reviews and Dissemination
citation: Chen X, Du MQ, Fan MW, Mulder J, Huysmans MC, Frencken JE. Caries-preventive effect of sealants produced with altered glass-ionomer materials, after 2 years. Dent Mater. 2012 May;28(5):554-60. doi: 10.1016/j.dental.2012.01.001. Epub 2012 Jan 31.
PMID: 22300651
citation: Chen X, Du M, Fan M, Mulder J, Huysmans MC, Frencken JE. Effectiveness of two new types of sealants: retention after 2 years. Clin Oral Investig. 2012 Oct;16(5):1443-50. doi: 10.1007/s00784-011-0633-9. Epub 2011 Nov 29.
PMID: 22124610
citation: Cvar JF, Ryge G. Reprint of criteria for the clinical evaluation of dental restorative materials. 1971. Clin Oral Investig. 2005 Dec;9(4):215-32. doi: 10.1007/s00784-005-0018-z. No abstract available.
PMID: 16315023
citation: Gorseta K, Glavina D, Borzabadi-Farahani A, Van Duinen RN, Skrinjaric I, Hill RG, Lynch E. One-year clinical evaluation of a Glass Carbomer fissure sealant, a preliminary study. Eur J Prosthodont Restor Dent. 2014 Jun;22(2):67-71.
PMID: 25134364
citation: Gu YW, Yap AU, Cheang P, Khor KA. Effects of incorporation of HA/ZrO(2) into glass ionomer cement (GIC). Biomaterials. 2005 Mar;26(7):713-20. doi: 10.1016/j.biomaterials.2004.03.019.
PMID: 15350775
citation: Hubel S, Mejare I. Conventional versus resin-modified glass-ionomer cement for Class II restorations in primary molars. A 3-year clinical study. Int J Paediatr Dent. 2003 Jan;13(1):2-8. doi: 10.1046/j.1365-263x.2003.00416.x.
PMID: 12542617
citation: Lucas ME, Arita K, Nishino M. Toughness, bonding and fluoride-release properties of hydroxyapatite-added glass ionomer cement. Biomaterials. 2003 Sep;24(21):3787-94. doi: 10.1016/s0142-9612(03)00260-6.
PMID: 12818551
citation: Lucas ME, Arita K, Nishino M. Strengthening a conventional glass ionomer cement using hydroxyapatite. J Dent Res. 2001;80:711.
citation: Moshaverinia A, Ansari S, Moshaverinia M, Roohpour N, Darr JA, Rehman I. Effects of incorporation of hydroxyapatite and fluoroapatite nanobioceramics into conventional glass ionomer cements (GIC). Acta Biomater. 2008 Mar;4(2):432-40. doi: 10.1016/j.actbio.2007.07.011. Epub 2007 Aug 25.
PMID: 17921077
responsible party type: Principal Investigator
investigator affiliation: King Abdulaziz University
investigator full name: Sumaya Nouri
investigator title: BDS, M.Sc
mesh term: Dental Caries
mesh term: Methamphetamine
sharing ipd: No