<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/NCT03306602</url>
  </required_header>
  <id_info>
    <org_study_id>MMMC/FOD/AR/B5/ E C-2017(26)</org_study_id>
    <nct_id>NCT03306602</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Bulk-fill vs Layered Composite Resin in Class I and II Posterior Restorations</brief_title>
  <official_title>Clinical Evaluation of Bulk-fill vs Layered Composite Resin in Class I and II Posterior Restorations: A Randomized Controlled Pilot Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Melaka Manipal Medical College</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Melaka Manipal Medical College</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to evaluate the clinical performance of Filtek Bulk Fill Posterior&#xD;
      Restorative in Class I and Class II restorations compared to the conventional incremental&#xD;
      technique using Filtek Z350XT over the period of 2 years. The null hypothesis of this study&#xD;
      is that the bulk-fill composite will exhibit same result and clinical performance as&#xD;
      conventional composite using incremental technique which has been used widely by dentists&#xD;
      nowadays.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In recent years, people are more concerned with the aesthetic qualities of dental&#xD;
      restorations and in response to enhancements in the resin technologies, tooth-colored resin&#xD;
      composite materials are increasingly being used for posterior teeth instead of amalgam&#xD;
      fillings. Developments during the years in chemical composition, filler reinforcement, and&#xD;
      adhesive techniques have resulted in many new modified categories of materials. Some&#xD;
      researchers recommend the use of the incremental technique, in which the composite material&#xD;
      is gradually placed in layers of 2mm or less.&#xD;
&#xD;
      This approach to restore teeth has a number of advantages, for example, it results in better&#xD;
      light penetration and better polymerization of composite resin, reduction in cavity&#xD;
      configuration factor, reduction in polymerization shrinkage stress and ensures that the resin&#xD;
      adheres to the cavity walls. During curing of the resin, a network of polymers is formed,&#xD;
      which becomes rigid due to increased cross linking of the polymer chains. Decreasing mobility&#xD;
      of the network causes further shrinkage and results in a strain on the resin composite and&#xD;
      cavity margins. The resulting stress has been associated with marginal deficiencies, enamel&#xD;
      fractures, cuspal movement, and cracked cusps, which in turn may result in microleakage,&#xD;
      post-operative sensitivity, and secondary caries. It has been stated that posterior class II&#xD;
      and especially class I cavities with a high C-factor will result in greater stresses due to a&#xD;
      larger number of bonded surfaces.&#xD;
&#xD;
      However, there are number of disadvantages associated with the use of an incremental approach&#xD;
      to place the resin. For example, voids can be trapped in between the increments, bonding&#xD;
      failure can occur in between the increments, difficulty in placing the composite material&#xD;
      after cavity preparation and the long time taken for the procedure. In an effort to counter&#xD;
      these problems, a new restorative material has been introduced in 2009 which is known as&#xD;
      'bulk-fill' composite, in order to increase efficiency of the operator. However, many&#xD;
      clinicians who have accustomed to the incremental cure philosophy when placing the&#xD;
      light-cured composite quite rightly question what has been changed to make these bulk-fill&#xD;
      light-cured composite a variable alternative. According to some researchers, bulk-fill&#xD;
      composite offers more advantages compared to the layered composite. These include increased&#xD;
      efficiency in working time, reduced polymerization shrinkage and reduces the risk of&#xD;
      contamination and voids forming between the resins.&#xD;
&#xD;
      The aim of this study is to evaluate the clinical performance of bulk-fill composite as&#xD;
      compared to the layered composite technique in class I and class II restorations over the&#xD;
      period of 2 years.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 30, 2017</start_date>
  <completion_date type="Anticipated">April 10, 2019</completion_date>
  <primary_completion_date type="Anticipated">January 30, 2019</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>
    <intervention_model_description>All the participants will receive both the experimental and control restoration. In the experimental cavity, Filtek Bulk Fill Posterior Restorative (3M ESPE) will be placed in 5 mm increments, eliminating the need for additional layers or multiple steps. The control restoration will be filled with Filtek Z350 XT (3M ESPE) using the 2 mm incremental layering technique.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>The cavity in an individual will be randomly assigned to either the experimental or the control restoration, according to a predetermined scheme of randomization. If the participants have two cavities, they will not know in which cavity the experimental and control restoration were placed. All the restorations will be analyzed by using Modified United States Public Health Services (USPHS) criteria. The investigators and outcome assessors evaluating the restorations will not know which tooth has been restored with the experimental or control restoration</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Modified United States Public Health Services (USPHS) criteria</measure>
    <time_frame>2 years</time_frame>
    <description>All the restorations will be analyzed by using Modified United States Public Health Services (USPHS) criteria, focusing more on the clinical criteria of the restoration. The characteristics of all the restorations will be described by using descriptive statistics using cumulative frequency distributions of the scores.</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">20</enrollment>
  <condition>Dental Caries Class I (Disorder)</condition>
  <condition>Dental Caries Class II</condition>
  <arm_group>
    <arm_group_label>Bulk Fill Composite</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In the experimental cavity, Filtek Bulk Fill Posterior Restorative (3M ESPE) will be placed in 5 mm increments, eliminating the need for additional layers or multiple steps.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Layered Composite</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control restoration will be filled with Filtek Z350 XT (3M ESPE) using the 2 mm incremental layering technique.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Filtek Bulk Fill Posterior Restorative</intervention_name>
    <description>Filtek™ Bulk Fill Posterior Restorative is a one-step bulk placement solution for fast and easy posterior resin restorations.</description>
    <arm_group_label>Bulk Fill Composite</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Filtek Z350 XT</intervention_name>
    <description>Filtek Z350XT is a material for incremental layered composite resin restorations</description>
    <arm_group_label>Layered Composite</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patient presenting with:&#xD;
&#xD;
          1. Any permanent premolar and molar requiring class I or II restorations;&#xD;
&#xD;
          2. Good oral hygiene;&#xD;
&#xD;
          3. Teeth in occlusion having at least one proximal contact with adjacent tooth;&#xD;
&#xD;
          4. Absence of any periodontal or pulpal pathology;&#xD;
&#xD;
          5. Absence of pain from the tooth to be restored;&#xD;
&#xD;
          6. Possible application of rubber dam during treatment&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Participants with unerupted tooth or partially erupted tooth,&#xD;
&#xD;
          2. Smoking,&#xD;
&#xD;
          3. Pregnant patients,&#xD;
&#xD;
          4. Severe bruxism habit,&#xD;
&#xD;
          5. Pathological pulpal or periodontal problems,&#xD;
&#xD;
          6. Fractured or visibly cracked teeth.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>N/A</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Prof. Abdul Rashid Hj Ismail, BDS,MSc,DDPH</last_name>
    <role>Study Chair</role>
    <affiliation>Melaka Manipal Medical College</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Dr. NASIL SAKKIR, BDS, MDS</last_name>
    <phone>0060177431474</phone>
    <email>nasil.sakkir@manipal.edu.my</email>
  </overall_contact>
  <location>
    <facility>
      <name>Melaka Manipal Medical College</name>
      <address>
        <city>Melaka Tengah</city>
        <state>Melaka</state>
        <zip>75150</zip>
        <country>Malaysia</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Dr. Nasil Sakkir</last_name>
      <phone>00606292 5849</phone>
      <phone_ext>3828</phone_ext>
      <email>nasil.sakkir@manipal.edu.my</email>
    </contact>
  </location>
  <location_countries>
    <country>Malaysia</country>
  </location_countries>
  <link>
    <url>http://multimedia.3m.com/mws/media/295038O/ryge-criteria-for-direct-clinical-evaluation-of-restoration.pdf?&amp;fn=usphs_ryge_criteria.pdf.</url>
    <description>Modified United States Public Health Service (USPHS) Ryge Criteria for Direct Clinical Evaluation of Restoration</description>
  </link>
  <reference>
    <citation>van Dijken JW, Pallesen U. Randomized 3-year clinical evaluation of Class I and II posterior resin restorations placed with a bulk-fill resin composite and a one-step self-etching adhesive. J Adhes Dent. 2015 Feb;17(1):81-8. doi: 10.3290/j.jad.a33502.</citation>
    <PMID>25625133</PMID>
  </reference>
  <reference>
    <citation>van Dijken JW, Pallesen U. Posterior bulk-filled resin composite restorations: A 5-year randomized controlled clinical study. J Dent. 2016 Aug;51:29-35. doi: 10.1016/j.jdent.2016.05.008. Epub 2016 May 26.</citation>
    <PMID>27238052</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>
  <verification_date>October 2017</verification_date>
  <study_first_submitted>October 3, 2017</study_first_submitted>
  <study_first_submitted_qc>October 5, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">October 11, 2017</study_first_posted>
  <last_update_submitted>October 5, 2017</last_update_submitted>
  <last_update_submitted_qc>October 5, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">October 11, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Melaka Manipal Medical College</investigator_affiliation>
    <investigator_full_name>Asst. Prof. Dr. NASIL SAKKIR</investigator_full_name>
    <investigator_title>Assistant Professor, Department of Conservative Dentistry and Endodontics</investigator_title>
  </responsible_party>
  <keyword>Composite Resins</keyword>
  <keyword>Dental Restorations</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>Z 350</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/NCT03306602
org study id: MMMC/FOD/AR/B5/ E C-2017(26)
nct id: NCT03306602
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The aim of this study is to evaluate the clinical performance of Filtek Bulk Fill Posterior
      Restorative in Class I and Class II restorations compared to the conventional incremental
      technique using Filtek Z350XT over the period of 2 years. The null hypothesis of this study
      is that the bulk-fill composite will exhibit same result and clinical performance as
      conventional composite using incremental technique which has been used widely by dentists
      nowadays.
In recent years, people are more concerned with the aesthetic qualities of dental
      restorations and in response to enhancements in the resin technologies, tooth-colored resin
      composite materials are increasingly being used for posterior teeth instead of amalgam
      fillings. Developments during the years in chemical composition, filler reinforcement, and
      adhesive techniques have resulted in many new modified categories of materials. Some
      researchers recommend the use of the incremental technique, in which the composite material
      is gradually placed in layers of 2mm or less.

      This approach to restore teeth has a number of advantages, for example, it results in better
      light penetration and better polymerization of composite resin, reduction in cavity
      configuration factor, reduction in polymerization shrinkage stress and ensures that the resin
      adheres to the cavity walls. During curing of the resin, a network of polymers is formed,
      which becomes rigid due to increased cross linking of the polymer chains. Decreasing mobility
      of the network causes further shrinkage and results in a strain on the resin composite and
      cavity margins. The resulting stress has been associated with marginal deficiencies, enamel
      fractures, cuspal movement, and cracked cusps, which in turn may result in microleakage,
      post-operative sensitivity, and secondary caries. It has been stated that posterior class II
      and especially class I cavities with a high C-factor will result in greater stresses due to a
      larger number of bonded surfaces.

      However, there are number of disadvantages associated with the use of an incremental approach
      to place the resin. For example, voids can be trapped in between the increments, bonding
      failure can occur in between the increments, difficulty in placing the composite material
      after cavity preparation and the long time taken for the procedure. In an effort to counter
      these problems, a new restorative material has been introduced in 2009 which is known as
      'bulk-fill' composite, in order to increase efficiency of the operator. However, many
      clinicians who have accustomed to the incremental cure philosophy when placing the
      light-cured composite quite rightly question what has been changed to make these bulk-fill
      light-cured composite a variable alternative. According to some researchers, bulk-fill
      composite offers more advantages compared to the layered composite. These include increased
      efficiency in working time, reduced polymerization shrinkage and reduces the risk of
      contamination and voids forming between the resins.

      The aim of this study is to evaluate the clinical performance of bulk-fill composite as
      compared to the layered composite technique in class I and class II restorations over the
      period of 2 years.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: All the participants will receive both the experimental and control restoration. In the experimental cavity, Filtek Bulk Fill Posterior Restorative (3M ESPE) will be placed in 5 mm increments, eliminating the need for additional layers or multiple steps. The control restoration will be filled with Filtek Z350 XT (3M ESPE) using the 2 mm incremental layering technique.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: The cavity in an individual will be randomly assigned to either the experimental or the control restoration, according to a predetermined scheme of randomization. If the participants have two cavities, they will not know in which cavity the experimental and control restoration were placed. All the restorations will be analyzed by using Modified United States Public Health Services (USPHS) criteria. The investigators and outcome assessors evaluating the restorations will not know which tooth has been restored with the experimental or control restoration
measure: Modified United States Public Health Services (USPHS) criteria
time frame: 2 years
description: All the restorations will be analyzed by using Modified United States Public Health Services (USPHS) criteria, focusing more on the clinical criteria of the restoration. The characteristics of all the restorations will be described by using descriptive statistics using cumulative frequency distributions of the scores.
arm group label: Bulk Fill Composite
arm group type: Experimental
description: In the experimental cavity, Filtek Bulk Fill Posterior Restorative (3M ESPE) will be placed in 5 mm increments, eliminating the need for additional layers or multiple steps.
arm group label: Layered Composite
arm group type: Active Comparator
description: The control restoration will be filled with Filtek Z350 XT (3M ESPE) using the 2 mm incremental layering technique.
intervention type: Device
intervention name: Filtek Bulk Fill Posterior Restorative
description: Filtek™ Bulk Fill Posterior Restorative is a one-step bulk placement solution for fast and easy posterior resin restorations.
arm group label: Bulk Fill Composite
intervention type: Device
intervention name: Filtek Z350 XT
description: Filtek Z350XT is a material for incremental layered composite resin restorations
arm group label: Layered Composite
criteria: 
gender: All
minimum age: N/A
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Prof. Abdul Rashid Hj Ismail, BDS,MSc,DDPH
role: Study Chair
affiliation: Melaka Manipal Medical College
last name: Dr. NASIL SAKKIR, BDS, MDS
phone: 0060177431474
email: nasil.sakkir@manipal.edu.my
facility: 
status: Recruiting
contact: 
country: Malaysia
url: http://multimedia.3m.com/mws/media/295038O/ryge-criteria-for-direct-clinical-evaluation-of-restoration.pdf?&fn=usphs_ryge_criteria.pdf.
description: Modified United States Public Health Service (USPHS) Ryge Criteria for Direct Clinical Evaluation of Restoration
citation: van Dijken JW, Pallesen U. Randomized 3-year clinical evaluation of Class I and II posterior resin restorations placed with a bulk-fill resin composite and a one-step self-etching adhesive. J Adhes Dent. 2015 Feb;17(1):81-8. doi: 10.3290/j.jad.a33502.
PMID: 25625133
citation: van Dijken JW, Pallesen U. Posterior bulk-filled resin composite restorations: A 5-year randomized controlled clinical study. J Dent. 2016 Aug;51:29-35. doi: 10.1016/j.jdent.2016.05.008. Epub 2016 May 26.
PMID: 27238052
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
responsible party type: Principal Investigator
investigator affiliation: Melaka Manipal Medical College
investigator full name: Asst. Prof. Dr. NASIL SAKKIR
investigator title: Assistant Professor, Department of Conservative Dentistry and Endodontics
mesh term: Dental Caries
mesh term: Z 350
sharing ipd: No