<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/NCT03802539</url>
  </required_header>
  <id_info>
    <org_study_id>HEK 11/54-8</org_study_id>
    <nct_id>NCT03802539</nct_id>
  </id_info>
  <brief_title>5-year Clinical Evaluation of Cavity Lining on the Restoration</brief_title>
  <official_title>5-year Clinical Evaluation of Cavity Lining on the Restoration of Root Surface Caries Lesions: A Controlled Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacettepe University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Hacettepe University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this double-blind, randomized trial is to compare the clinical performance of&#xD;
      a composite restorations in root surface carious lesions with or without resin modified glass&#xD;
      ionomer lining.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Thirty-nine patients with at least one pair of equivalent root caries lesions and a mean age&#xD;
      of 39.6 years (range 18-65 years; median 39 years) were enrolled in this study. After caries&#xD;
      removal, the depth, length, and width of the cavity were measured. Lesions in the same&#xD;
      patient was randomly divided into two groups, and the dentin surfaces were either lined with&#xD;
      resin-modified glass ionomer liner (Glass liner II, Willmann &amp; Pein GmbH Dental, Barmstedt,&#xD;
      Germany) or not. All cavities were restored with nanohybrid composite resin (Clearfil Majesty&#xD;
      Esthetic, Kuraray, Tokyo, Japan). A total of 100 restorations (50 lined, 50 unlined) were&#xD;
      placed according to manufacturer's instructions. The restorations will be evaluated at&#xD;
      baseline and at 6, 12, 24, 36, 48 months and 5-year after placement using the modified&#xD;
      Haveman Criteria for marginal adaptation, anatomic form, marginal staining, anatomic form,&#xD;
      caries in adjacent tooth structure, caries at the cavosurface margin and sensitivity.&#xD;
      Statistical analysis will be conducted using the Chi- Square, Fisher's Exact, Mann Whitney-U&#xD;
      and Cochran Q tests at a significance level of 5% (P &lt; 0.05).&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">January 1, 2014</start_date>
  <completion_date type="Anticipated">January 1, 2020</completion_date>
  <primary_completion_date type="Actual">July 1, 2016</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>Factorial Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retention Outcome</measure>
    <time_frame>5 years</time_frame>
    <description>1.Retention Alpha for at least 90% of the restorations The primary factor for determining the clinical performance of a restorative material is the retention rate. It represents the survival rates of the restorations after a period of time. According to ADA (American Dental Association) guidelines, a restorative material should show at leat 90% alpha retention rate after 18 months to be considered as clinically acceptable. The retention is assessed as alpha (retentive restoration) or charlie (failed restoration). Clinical evaluation is performed to examine if the restoration is in place or has fallen.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">38</enrollment>
  <condition>Teeth; Lesion</condition>
  <condition>Dental Root Caries</condition>
  <arm_group>
    <arm_group_label>Glass Liner</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Tooth restoration with a glass ionomer liner material under a nanohybrid composite resin</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No liner</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Tooth restoration without a glass ionomer liner material under a nanohybrid composite resin</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Glass Liner</intervention_name>
    <description>restoration of root caries according to two different protocols</description>
    <arm_group_label>Glass Liner</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Non-hospitalized, healthy patients that were seeking dental treatment for caries&#xD;
             lesions on the root surface&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who were under the age of 18 years&#xD;
&#xD;
          -  Complex medical history&#xD;
&#xD;
          -  Severe or chronic periodontitis&#xD;
&#xD;
          -  Extreme carious activity&#xD;
&#xD;
          -  Heavy bruxism&#xD;
&#xD;
          -  Very deep or superficial carious lesions&#xD;
&#xD;
          -  Previously restored and abutment teeth&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>67 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 6, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 14, 2019</study_first_posted>
  <last_update_submitted>January 9, 2019</last_update_submitted>
  <last_update_submitted_qc>January 9, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 14, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Hacettepe University</investigator_affiliation>
    <investigator_full_name>Uzay Koc</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Root caries</keyword>
  <keyword>Cavity lining</keyword>
  <keyword>Composite resin restorations</keyword>
  <keyword>Self-etch adhesive</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Root Caries</mesh_term>
  </condition_browse>
  <!-- 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/NCT03802539
org study id: HEK 11/54-8
nct id: NCT03802539
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
is us export: No
The purpose of this double-blind, randomized trial is to compare the clinical performance of
      a composite restorations in root surface carious lesions with or without resin modified glass
      ionomer lining.
Thirty-nine patients with at least one pair of equivalent root caries lesions and a mean age
      of 39.6 years (range 18-65 years; median 39 years) were enrolled in this study. After caries
      removal, the depth, length, and width of the cavity were measured. Lesions in the same
      patient was randomly divided into two groups, and the dentin surfaces were either lined with
      resin-modified glass ionomer liner (Glass liner II, Willmann & Pein GmbH Dental, Barmstedt,
      Germany) or not. All cavities were restored with nanohybrid composite resin (Clearfil Majesty
      Esthetic, Kuraray, Tokyo, Japan). A total of 100 restorations (50 lined, 50 unlined) were
      placed according to manufacturer's instructions. The restorations will be evaluated at
      baseline and at 6, 12, 24, 36, 48 months and 5-year after placement using the modified
      Haveman Criteria for marginal adaptation, anatomic form, marginal staining, anatomic form,
      caries in adjacent tooth structure, caries at the cavosurface margin and sensitivity.
      Statistical analysis will be conducted using the Chi- Square, Fisher's Exact, Mann Whitney-U
      and Cochran Q tests at a significance level of 5% (P < 0.05).
allocation: Randomized
intervention model: Factorial Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Retention Outcome
time frame: 5 years
description: 1.Retention Alpha for at least 90% of the restorations The primary factor for determining the clinical performance of a restorative material is the retention rate. It represents the survival rates of the restorations after a period of time. According to ADA (American Dental Association) guidelines, a restorative material should show at leat 90% alpha retention rate after 18 months to be considered as clinically acceptable. The retention is assessed as alpha (retentive restoration) or charlie (failed restoration). Clinical evaluation is performed to examine if the restoration is in place or has fallen.
arm group label: Glass Liner
arm group type: Experimental
description: Tooth restoration with a glass ionomer liner material under a nanohybrid composite resin
arm group label: No liner
arm group type: No Intervention
description: Tooth restoration without a glass ionomer liner material under a nanohybrid composite resin
intervention type: Device
intervention name: Glass Liner
description: restoration of root caries according to two different protocols
arm group label: Glass Liner
criteria: 
gender: All
minimum age: 18 Years
maximum age: 67 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Hacettepe University
investigator full name: Uzay Koc
investigator title: Principal Investigator
mesh term: Root Caries