xml: <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/NCT06005571</url>
    </required_header>
    <id_info>
      <org_study_id>20220082</org_study_id>
      <nct_id>NCT06005571</nct_id>
    </id_info>
    <brief_title>Effect of Silane Coupling on the Clinical Performance of Repaired Composite</brief_title>
    <official_title>Effect of Silane Coupling Treatment on the Clinical Performance of Direct Repaired Resin-based Composite: A Randomized Controlled Trial.</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>King Abdullah University Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>Jordan University of Science and Technology</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>King Abdullah University Hospital</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        Research Problem : Advances in adhesive technologies have introduced several surface&#xD;
        treatment concepts that enable the clinician to adhere resin-based composite restorations&#xD;
        onto new composite materials. The service life of faulty direct composite restorations can be&#xD;
        prolonged by composite repair wherein durable adhesion between old and new resin-based&#xD;
        composite materials is established.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Objectives : A randomized controlled clinical trial was designed to apply the latest results&#xD;
        of evidence-based in vitro studies regarding resin-based repair protocol. The study aimed to&#xD;
        assess the effect of adding silane coupling agent as a separate step on the clinical&#xD;
        performance of repaired composite restorations and compare the results with those of using&#xD;
        the usual etch and bond protocol.&#xD;
  &#xD;
        Materials and Methods : 45 patients were recruited for this study from patients attending the&#xD;
        restorative dentistry clinics for postgraduate students, Jordan University of Science and&#xD;
        Technology. Each patient had at least two defected posterior composite restorations that are&#xD;
        indicated for repair. With this selection, 116 restorations with localized anatomical&#xD;
        deficiencies and/or secondary caries were randomly assigned into three groups according to&#xD;
        the type of surface treatment each tooth will receive before the application of the new&#xD;
        composite material (Filtek Z250,3M,USA). The teeth in the control group (n = 45): were&#xD;
        treated with 37% phosphoric acid etching and conventional one step adhesive (Single&#xD;
        Bond,3M,USA). In the Silane-Adhesive group (n = 26): teeth were treated with acid etching and&#xD;
        silane coupling agent application (Bis-silane) prior to adhesive bond (Adper single bond). In&#xD;
        the Sandblast-Silane-Adhesive group (n = 45): teeth were treated with intra-oral sandblasting&#xD;
        and silane coupling agent application (Bis-silane) prior to (Adper Single Bond). The reason&#xD;
        of repair, age of old restorations and the location of the restoration-repair interfaces were&#xD;
        recorded for every failed restorations. Two examiners followed-up and evaluated the&#xD;
        restoration quality after an average of 6 months using modified USPHS criteria. The results&#xD;
        of clinical performance were assessed using Chi-square test.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Active, not recruiting</overall_status>
    <start_date type="Actual">March 10, 2022</start_date>
    <completion_date type="Anticipated">September 15, 2023</completion_date>
    <primary_completion_date type="Actual">September 30, 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>
      <intervention_model_description>Three groups of patients were randomly assigned to three different treatment protocols of defective composite restoration repair.</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Double (Participant, Outcomes Assessor)</masking>
      <masking_description>The patients who participated in the study and the assessor of the treatment outcome did not know the type of treatment procedure received.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Assessment of the quality of the repaired restoration retention, colour match, marginal discoloration, marginal adaptation, anatomical form and surface roughness.</measure>
      <time_frame>2 years</time_frame>
      <description>Clinical examination and evaluation of the restoration quality according to the United States Public Health Service (USPHS) criteria as Alpha, Bravo and Charlie. Alpha scores mean a better outcome and Charlie scores mean worse outcome.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>The presence of postoperative sensitivity.</measure>
      <time_frame>2 years.</time_frame>
      <description>Patients record their sensitivity in treated teeth and score its intensity on visual analogue scale (VAS) which was divided into 10 digits from 0 to 10 where scores from 0 to less than 5 mean &quot;bearable sesitivity&quot; and scores from 5 to10 mean &quot;unbearable sensitivy&quot; outcome.</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Actual">43</enrollment>
    <condition>Defective Composite Restorations</condition>
    <arm_group>
      <arm_group_label>Control: traditional acid etch treatment group</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Traditional acid etching to the tooth and old restoration surfaces and then adhesive application.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Silane-Adhesive treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Acid cid etching of prepared tooth tissues and old restoration surfaces, silane solution application, and then adhesive application.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Sandblast-Silane-Adhesive treatment group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>First sandblasting the old composite filling surfaces, then acid etching of prepared tooth tissues the restoration, then silane application followed by adhesive application.</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>composite restoration repair by traditional acid etch treatment procedure and adhesive.</intervention_name>
      <description>Recurrent caries surrounding the defective restoration was removed and the surfaces were coditoned with acid and adhesive then new repair composite was addded to repair the old restoration and restore the carious cavity.</description>
      <arm_group_label>Control: traditional acid etch treatment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Composite restoration repair by acid etching, silane solution application, and then adhesive.</intervention_name>
      <description>Recurrent caries surrounding the defective restoration was removed and the surfaces were coditoned with acid, then silane applied, next adhesive then new repair composite was addded to repair the old restoration and restore the carious cavity.</description>
      <arm_group_label>Silane-Adhesive treatment group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Composite restoration repair by sandblasting first, then acid etching, silane solution application, and then adhesive.</intervention_name>
      <description>Recurrent caries surrounding the defective restoration was removed, the old restoration surface were sandblasted, and the tooth and restoration surfaces were coditoned with acid, then silane applied, next adhesive then new repair composite was added to repair the old restoration and restore the carious cavity.</description>
      <arm_group_label>Sandblast-Silane-Adhesive treatment group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Deciduous tooth&#xD;
  &#xD;
            -  Sustained dentin hypersensitivity&#xD;
  &#xD;
            -  Irreversible pulpitis , necrotic, or inadequately-treated endodontic teeth&#xD;
  &#xD;
            -  Grossly defective composite restorations that were indicated for replacement.&#xD;
  &#xD;
            -  Teeth with compromised periodontal status.&#xD;
  &#xD;
            -  Patients with poor oral hygiene&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Patients older than 18 years.&#xD;
  &#xD;
            -  Asymptomatic restored premolars or molars.&#xD;
  &#xD;
            -  Vital or endodontically treated teeth&#xD;
  &#xD;
            -  Patients with localized, marginal, anatomical deficiencies and/or carious lesions&#xD;
               adjacent to composite restorations or esthetically unpleasant restorations.&#xD;
  &#xD;
            -  Teeth with marginal gingivitis but healthy periodontium.&#xD;
  &#xD;
            -  Tooth in normal occlusion with antagonist and at least one adjacent tooth.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>N/A</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Zakereyya Albashaireh, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Jordan University of Science and Technology</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Jordan University of Science and Technology</name>
        <address>
          <city>Irbid</city>
          <zip>21110</zip>
          <country>Jordan</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Jordan</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 21, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 22, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 22, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Jordan University of Science and Technology</investigator_affiliation>
      <investigator_full_name>Zakereyya Albashaireh</investigator_full_name>
      <investigator_title>Professor of restorative dentistry</investigator_title>
    </responsible_party>
    <keyword>Silane</keyword>
    <keyword>Sandblasting of tooth surfaces</keyword>
    <keyword>Clinical trial</keyword>
    <keyword>dentine bonding</keyword>
    <keyword>Composite repair</keyword>
    <keyword>defective restorations</keyword>
    <intervention_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Pharmaceutical Solutions</mesh_term>
    </intervention_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>A consent has to be obtained from the faculty of graduate studies for sharing data as data form part of graduate students thesis.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06005571
  org study id: 20220082
  nct id: NCT06005571
  lead sponsor: 
  collaborator: 
  is fda regulated drug: No
  is fda regulated device: No
  Research Problem : Advances in adhesive technologies have introduced several surface
        treatment concepts that enable the clinician to adhere resin-based composite restorations
        onto new composite materials. The service life of faulty direct composite restorations can be
        prolonged by composite repair wherein durable adhesion between old and new resin-based
        composite materials is established.
  Objectives : A randomized controlled clinical trial was designed to apply the latest results
        of evidence-based in vitro studies regarding resin-based repair protocol. The study aimed to
        assess the effect of adding silane coupling agent as a separate step on the clinical
        performance of repaired composite restorations and compare the results with those of using
        the usual etch and bond protocol.
  
        Materials and Methods : 45 patients were recruited for this study from patients attending the
        restorative dentistry clinics for postgraduate students, Jordan University of Science and
        Technology. Each patient had at least two defected posterior composite restorations that are
        indicated for repair. With this selection, 116 restorations with localized anatomical
        deficiencies and/or secondary caries were randomly assigned into three groups according to
        the type of surface treatment each tooth will receive before the application of the new
        composite material (Filtek Z250,3M,USA). The teeth in the control group (n = 45): were
        treated with 37% phosphoric acid etching and conventional one step adhesive (Single
        Bond,3M,USA). In the Silane-Adhesive group (n = 26): teeth were treated with acid etching and
        silane coupling agent application (Bis-silane) prior to adhesive bond (Adper single bond). In
        the Sandblast-Silane-Adhesive group (n = 45): teeth were treated with intra-oral sandblasting
        and silane coupling agent application (Bis-silane) prior to (Adper Single Bond). The reason
        of repair, age of old restorations and the location of the restoration-repair interfaces were
        recorded for every failed restorations. Two examiners followed-up and evaluated the
        restoration quality after an average of 6 months using modified USPHS criteria. The results
        of clinical performance were assessed using Chi-square test.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Three groups of patients were randomly assigned to three different treatment protocols of defective composite restoration repair.
  primary purpose: Treatment
  masking: Double (Participant, Outcomes Assessor)
  masking description: The patients who participated in the study and the assessor of the treatment outcome did not know the type of treatment procedure received.
  measure: Assessment of the quality of the repaired restoration retention, colour match, marginal discoloration, marginal adaptation, anatomical form and surface roughness.
  time frame: 2 years
  description: Clinical examination and evaluation of the restoration quality according to the United States Public Health Service (USPHS) criteria as Alpha, Bravo and Charlie. Alpha scores mean a better outcome and Charlie scores mean worse outcome.
  measure: The presence of postoperative sensitivity.
  time frame: 2 years.
  description: Patients record their sensitivity in treated teeth and score its intensity on visual analogue scale (VAS) which was divided into 10 digits from 0 to 10 where scores from 0 to less than 5 mean "bearable sesitivity" and scores from 5 to10 mean "unbearable sensitivy" outcome.
  arm group label: Control: traditional acid etch treatment group
  arm group type: Active Comparator
  description: Traditional acid etching to the tooth and old restoration surfaces and then adhesive application.
  arm group label: Silane-Adhesive treatment group
  arm group type: Experimental
  description: Acid cid etching of prepared tooth tissues and old restoration surfaces, silane solution application, and then adhesive application.
  arm group label: Sandblast-Silane-Adhesive treatment group
  arm group type: Experimental
  description: First sandblasting the old composite filling surfaces, then acid etching of prepared tooth tissues the restoration, then silane application followed by adhesive application.
  intervention type: Procedure
  intervention name: composite restoration repair by traditional acid etch treatment procedure and adhesive.
  description: Recurrent caries surrounding the defective restoration was removed and the surfaces were coditoned with acid and adhesive then new repair composite was addded to repair the old restoration and restore the carious cavity.
  arm group label: Control: traditional acid etch treatment group
  intervention type: Procedure
  intervention name: Composite restoration repair by acid etching, silane solution application, and then adhesive.
  description: Recurrent caries surrounding the defective restoration was removed and the surfaces were coditoned with acid, then silane applied, next adhesive then new repair composite was addded to repair the old restoration and restore the carious cavity.
  arm group label: Silane-Adhesive treatment group
  intervention type: Procedure
  intervention name: Composite restoration repair by sandblasting first, then acid etching, silane solution application, and then adhesive.
  description: Recurrent caries surrounding the defective restoration was removed, the old restoration surface were sandblasted, and the tooth and restoration surfaces were coditoned with acid, then silane applied, next adhesive then new repair composite was added to repair the old restoration and restore the carious cavity.
  arm group label: Sandblast-Silane-Adhesive treatment group
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Zakereyya Albashaireh, PhD
  role: Principal Investigator
  affiliation: Jordan University of Science and Technology
  facility: 
  country: Jordan
  responsible party type: Principal Investigator
  investigator affiliation: Jordan University of Science and Technology
  investigator full name: Zakereyya Albashaireh
  investigator title: Professor of restorative dentistry
  mesh term: Pharmaceutical Solutions
  sharing ipd: No
  ipd description: A consent has to be obtained from the faculty of graduate studies for sharing data as data form part of graduate students thesis.