<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/NCT02185573</url>
  </required_header>
  <id_info>
    <org_study_id>UDDS-OperDent-01-2014</org_study_id>
    <nct_id>NCT02185573</nct_id>
  </id_info>
  <brief_title>Evaluation of Two Different Methods of Resin Composite Application In Class II Restorations</brief_title>
  <official_title>Evaluation of Two Different Methods of Resin Composite Application Using Bulk-fill Technique In Class II Restorations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Damascus University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Damascus University</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Three clinical groups will be evaluated. Each group of patients will undergo one method of&#xD;
      Resin Composite application (multi-layer technique 'control group' - bulk-fill Technique -&#xD;
      Sonicfill technique). The restored teeth will be followed-up till one year. A comparison is&#xD;
      going to be made between the three groups in relation to the modified United Sates Public&#xD;
      Health Service (USPHS) criteria of good restorations.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The modified USPHS criteria include the evaluation of seven characteristics of the&#xD;
      restorations: color match, marginal integrity, surface texture, wear of both restoration and&#xD;
      antagonist, recurrent dental caries, fracture or detachment, and gingivitis around the&#xD;
      abutment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>July 2014</start_date>
  <completion_date type="Actual">October 2015</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Change in Color Match</measure>
    <time_frame>Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.</time_frame>
    <description>Color match&#xD;
The restoration appears to match the shade and translucency of adjacent tooth tissues.&#xD;
The restoration does not match the shade and translucency of adjacent tooth tissues, but the mismatch is within the range of tooth shade.&#xD;
The restoration does not match the shade and translucency of adjacent tooth tissues, and the mismatch is outside the normal range of tooth shade and translucency.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Marginal Integrity</measure>
    <time_frame>Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.</time_frame>
    <description>Marginal integrity&#xD;
The explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does catch, there is no visible crevice along the periphery of the restoration.&#xD;
The explorer catches and there is visible evidence of crevice, into which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure.&#xD;
the explorer penetrates a crevice defect.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Surface Texture</measure>
    <time_frame>Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.</time_frame>
    <description>Surface texture:&#xD;
Surface texture is similar to polished enamel as determined by means of a sharp explorer.&#xD;
Surface texture is gritty similar to a surface subject to a white stone or similar to a composite containing supramicron sizes particles.&#xD;
Surface pitting is sufficiently coarse to inhibit the continuous movement of an explorer across the surface.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in Restoration Wear</measure>
    <time_frame>Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.</time_frame>
    <description>Wear&#xD;
The restoration is continuation of existing anatomic form or is slightly flattened.&#xD;
A surface concavity is evident.&#xD;
There is a loss of restorative substance such that a surface concavity is evident. Replacement or restorative treatment is required.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Recurrent dental caries</measure>
    <time_frame>Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.</time_frame>
    <description>Recurrent dental caries:&#xD;
The restoration is a continuation of existing anatomic form adjacent to the restoration.&#xD;
There is visual evidence of dark deep discoloration adjacent to the restoration.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>The Fracture/detachment Status</measure>
    <time_frame>Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.</time_frame>
    <description>Fracture/detachment:&#xD;
No bulk fracture/detachment is present.&#xD;
Bulk fracture/ detachment is evident.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Change in gingival status</measure>
    <time_frame>Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.</time_frame>
    <description>Gingival status&#xD;
No clinical inflammation is present.&#xD;
Clinical inflammation is present.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Class II Dental Restorations</condition>
  <arm_group>
    <arm_group_label>Conventional Technique</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
    <description>Multi-layer filling technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Bulk fill technique</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Bulk fill technique</description>
  </arm_group>
  <arm_group>
    <arm_group_label>SonicFill technique</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SonicFill technique</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Bulk fill</intervention_name>
    <description>This is one of the composite restoration application techniques</description>
    <arm_group_label>Bulk fill technique</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SonicFill</intervention_name>
    <description>This is the recent intervention under evaluation</description>
    <arm_group_label>SonicFill technique</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Cooperated patients.&#xD;
&#xD;
          2. Good general health.&#xD;
&#xD;
          3. Good oral hygiene.&#xD;
&#xD;
          4. Aged 15 to 60 years.&#xD;
&#xD;
          5. Class II restoration (upper or lower)&#xD;
&#xD;
          6. Full erupted teeth.&#xD;
&#xD;
          7. Caries value D3 -D4 according to Daignodent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. If the caries value according to Daignodent is less than D3 -D4.&#xD;
&#xD;
          2. If the tooth is partially erupted.&#xD;
&#xD;
          3. Class II box-like cavity only without any extensions.&#xD;
&#xD;
          4. Patient outside the required age range (15-60 years).&#xD;
&#xD;
          5. Bad oral hygiene.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>15 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Rahaf Alkurdi, DDS MSc</last_name>
    <role>Principal Investigator</role>
    <affiliation>PhD student, Department of Operative Dentistry, University of Damascus Dental School, Damascus</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Souad Abboud, DDS MSc PhD</last_name>
    <role>Study Director</role>
    <affiliation>Associate Professor, Operative Dentistry Department, University of Damascus Dental School, Damascus</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of Operative Dentistry, University of Damascus Dental School</name>
      <address>
        <city>Damascus</city>
        <zip>DM20AM18</zip>
        <country>Syrian Arab Republic</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Syrian Arab Republic</country>
  </location_countries>
  <reference>
    <citation>Manhart J, Hickel R. [Bulk-fill-composites. Modern application technique of direct composites for posterior teeth]. Swiss Dent J. 2014;124(1):19-37. French, German.</citation>
    <PMID>24665478</PMID>
  </reference>
  <reference>
    <citation>van Dijken JW, Pallesen U. A randomized controlled three year evaluation of &quot;bulk-filled&quot; posterior resin restorations based on stress decreasing resin technology. Dent Mater. 2014 Sep;30(9):e245-51. doi: 10.1016/j.dental.2014.05.028. Epub 2014 Jun 21.</citation>
    <PMID>24958689</PMID>
  </reference>
  <reference>
    <citation>Ching K. Deep and fast: Kerr's SonicFill bulk fill composite. HDA Now. 2012 Spring:24-5. No abstract available.</citation>
    <PMID>22984718</PMID>
  </reference>
  <reference>
    <citation>Furness A, Tadros MY, Looney SW, Rueggeberg FA. Effect of bulk/incremental fill on internal gap formation of bulk-fill composites. J Dent. 2014 Apr;42(4):439-49. doi: 10.1016/j.jdent.2014.01.005. Epub 2014 Jan 27.</citation>
    <PMID>24480086</PMID>
  </reference>
  <reference>
    <citation>Campos EA, Ardu S, Lefever D, Jasse FF, Bortolotto T, Krejci I. Marginal adaptation of class II cavities restored with bulk-fill composites. J Dent. 2014 May;42(5):575-81. doi: 10.1016/j.jdent.2014.02.007. Epub 2014 Feb 18.</citation>
    <PMID>24561041</PMID>
  </reference>
  <verification_date>October 2015</verification_date>
  <study_first_submitted>July 4, 2014</study_first_submitted>
  <study_first_submitted_qc>July 4, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">July 9, 2014</study_first_posted>
  <last_update_submitted>October 2, 2015</last_update_submitted>
  <last_update_submitted_qc>October 2, 2015</last_update_submitted_qc>
  <last_update_posted type="Estimate">October 5, 2015</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>Bulk fill</keyword>
  <keyword>SonicFill</keyword>
  <keyword>resin composite application</keyword>
  <keyword>class II restoration</keyword>
  <!-- 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/NCT02185573
org study id: UDDS-OperDent-01-2014
nct id: NCT02185573
lead sponsor: 
has dmc: Yes
Three clinical groups will be evaluated. Each group of patients will undergo one method of
      Resin Composite application (multi-layer technique 'control group' - bulk-fill Technique -
      Sonicfill technique). The restored teeth will be followed-up till one year. A comparison is
      going to be made between the three groups in relation to the modified United Sates Public
      Health Service (USPHS) criteria of good restorations.
The modified USPHS criteria include the evaluation of seven characteristics of the
      restorations: color match, marginal integrity, surface texture, wear of both restoration and
      antagonist, recurrent dental caries, fracture or detachment, and gingivitis around the
      abutment.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: Change in Color Match
time frame: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
description: Color match
The restoration appears to match the shade and translucency of adjacent tooth tissues.
The restoration does not match the shade and translucency of adjacent tooth tissues, but the mismatch is within the range of tooth shade.
The restoration does not match the shade and translucency of adjacent tooth tissues, and the mismatch is outside the normal range of tooth shade and translucency.
measure: Change in Marginal Integrity
time frame: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
description: Marginal integrity
The explorer does not catch when drawn across the surface of the restoration toward the tooth, or, if the explorer does catch, there is no visible crevice along the periphery of the restoration.
The explorer catches and there is visible evidence of crevice, into which the explorer penetrates, indicating that the edge of the restoration does not adapt closely to the tooth structure.
the explorer penetrates a crevice defect.
measure: Change in Surface Texture
time frame: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
description: Surface texture:
Surface texture is similar to polished enamel as determined by means of a sharp explorer.
Surface texture is gritty similar to a surface subject to a white stone or similar to a composite containing supramicron sizes particles.
Surface pitting is sufficiently coarse to inhibit the continuous movement of an explorer across the surface.
measure: Change in Restoration Wear
time frame: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
description: Wear
The restoration is continuation of existing anatomic form or is slightly flattened.
A surface concavity is evident.
There is a loss of restorative substance such that a surface concavity is evident. Replacement or restorative treatment is required.
measure: Recurrent dental caries
time frame: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
description: Recurrent dental caries:
The restoration is a continuation of existing anatomic form adjacent to the restoration.
There is visual evidence of dark deep discoloration adjacent to the restoration.
measure: The Fracture/detachment Status
time frame: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
description: Fracture/detachment:
No bulk fracture/detachment is present.
Bulk fracture/ detachment is evident.
measure: Change in gingival status
time frame: Assessment will be done at (T0) within the first hour following composite sitting, (T1) after 3 months, (T2) after six months, (T3) after six months, (T4) at 12 months following application.
description: Gingival status
No clinical inflammation is present.
Clinical inflammation is present.
arm group label: Conventional Technique
arm group type: No Intervention
description: Multi-layer filling technique
arm group label: Bulk fill technique
arm group type: Active Comparator
description: Bulk fill technique
arm group label: SonicFill technique
arm group type: Experimental
description: SonicFill technique
intervention type: Procedure
intervention name: Bulk fill
description: This is one of the composite restoration application techniques
arm group label: Bulk fill technique
intervention type: Procedure
intervention name: SonicFill
description: This is the recent intervention under evaluation
arm group label: SonicFill technique
criteria: 
gender: All
minimum age: 15 Years
maximum age: 60 Years
healthy volunteers: No
last name: Rahaf Alkurdi, DDS MSc
role: Principal Investigator
affiliation: PhD student, Department of Operative Dentistry, University of Damascus Dental School, Damascus
last name: Souad Abboud, DDS MSc PhD
role: Study Director
affiliation: Associate Professor, Operative Dentistry Department, University of Damascus Dental School, Damascus
facility: 
country: Syrian Arab Republic
citation: Manhart J, Hickel R. [Bulk-fill-composites. Modern application technique of direct composites for posterior teeth]. Swiss Dent J. 2014;124(1):19-37. French, German.
PMID: 24665478
citation: van Dijken JW, Pallesen U. A randomized controlled three year evaluation of "bulk-filled" posterior resin restorations based on stress decreasing resin technology. Dent Mater. 2014 Sep;30(9):e245-51. doi: 10.1016/j.dental.2014.05.028. Epub 2014 Jun 21.
PMID: 24958689
citation: Ching K. Deep and fast: Kerr's SonicFill bulk fill composite. HDA Now. 2012 Spring:24-5. No abstract available.
PMID: 22984718
citation: Furness A, Tadros MY, Looney SW, Rueggeberg FA. Effect of bulk/incremental fill on internal gap formation of bulk-fill composites. J Dent. 2014 Apr;42(4):439-49. doi: 10.1016/j.jdent.2014.01.005. Epub 2014 Jan 27.
PMID: 24480086
citation: Campos EA, Ardu S, Lefever D, Jasse FF, Bortolotto T, Krejci I. Marginal adaptation of class II cavities restored with bulk-fill composites. J Dent. 2014 May;42(5):575-81. doi: 10.1016/j.jdent.2014.02.007. Epub 2014 Feb 18.
PMID: 24561041
responsible party type: Sponsor