<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/NCT02222701</url>
  </required_header>
  <id_info>
    <org_study_id>FOUCH2012/10-4</org_study_id>
    <nct_id>NCT02222701</nct_id>
  </id_info>
  <brief_title>Composite Resins Reconditioned, Behavior and Survival: Clinical Follow-up 10 Years</brief_title>
  <acronym>reacondcomp</acronym>
  <official_title>Composite Resins Reconditioned, Behavior and Survival: Clinical Follow-up 10 Years</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Chile</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Chile</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The purpose of this study is to evaluate the clinical performance of resin composite&#xD;
      restorations refurbished and compare with 2 groups of resins, 1 without treatment and another&#xD;
      replaced resins acted as controls. The null hypothesis of this study is that the group of&#xD;
      refurbished resins have a similar behavior to the control groups.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      A cohort of 26 patients aged 18-80 years old (mean: 28.35 years; 42% men, 58% women) with 78&#xD;
      composite restorations (Class I: 39; Class II: 39) were recruited at the Operative Dentistry&#xD;
      Clinic at the Dental School of the University of Chile. All participants in the refurbishing&#xD;
      groups showed clinical features for the anantomy, roughness and/or luster that deviated from&#xD;
      the ideal and were rated Bravo according to the modified United States Public Health Service&#xD;
      (USPHS) criteria. New Composites with Alpha values (Replacement group) and acceptable&#xD;
      composites (No treatment group) were used as controls. The protocol was approved by the&#xD;
      Institutional Research Ethics Committee of the Dental School at the University of Chile&#xD;
      (Project PRI-ODO-0207). All patients signed informed-consent forms and completed registration&#xD;
      forms&#xD;
&#xD;
      General Inclusion Criteria:&#xD;
&#xD;
        -  Patients with more than 20 teeth.&#xD;
&#xD;
        -  Restorations in functional occlusion, with an opposing natural tooth.&#xD;
&#xD;
        -  Asymptomatic restored tooth.&#xD;
&#xD;
        -  At least one proximal contact area with a neighboring tooth.&#xD;
&#xD;
        -  Patients older than 18 years.&#xD;
&#xD;
        -  Patients who agreed and signed a consent form for participating in the study.&#xD;
&#xD;
        -  Area outside of the restoration failure is in good condition.&#xD;
&#xD;
      General Exclusion Criteria:&#xD;
&#xD;
        -  Patients with contra-indications for regular dental treatment based on their medical&#xD;
           history.&#xD;
&#xD;
        -  Patients with xerostomia or individuals taking medication that significantly decreased&#xD;
           salivary flow.&#xD;
&#xD;
        -  Patients with a high risk of caries.&#xD;
&#xD;
        -  Patients with psychiatric or physical diseases, which interfered with oral hygiene.&#xD;
&#xD;
      Treatment Group Criteria Two hundred four patients were initially evaluated and assigned in&#xD;
      accordance with the modified USPHS criteria,26 patients were selected based on the inclusion&#xD;
      criteria with at least 1 Composite restoration with anatomy, roughness and/or luster (Bravo)&#xD;
      suitable for reburbishing, with another composite restorations that had excellent values&#xD;
      (Alpha) and was made at this time (Replacement group).And finally another composite&#xD;
      pre-existing with acceptable condition (Alpha or Bravo values) acted as control. The patient&#xD;
      was considered the statistical unit in this study (n=20).&#xD;
&#xD;
      Restoration Assessment The quality of the restorations was scored in accordance with the&#xD;
      modified USPHS criteria. The Cohen Kappa inter-examiner coefficient was 0.74 in the first&#xD;
      year and 0.87 after 10 years for two examiners (JM and EF) who underwent calibration training&#xD;
      exercises each year. In the first, second, third, fourth, fifth, and tenth years, the&#xD;
      examiners independently assessed the restorations for anatomic form, roughness, color,&#xD;
      marginal staining,luster, secondary caries, marginal and marginal adaptation, both directly&#xD;
      via tactile and visual examinations with mouth mirror number five and explorer number 23 (Hu&#xD;
      Friedy Mfg. Co. Inc.) and indirectly by radiographic examination (bite wing). A third&#xD;
      clinician (GM), who also underwent the calibration training exercises, made the final&#xD;
      decision if a difference was recorded between the two examiners and they could not reach an&#xD;
      agreement.&#xD;
&#xD;
      Treatment Groups Refurbishing For this group, The dentists finished the occlusal, lingual or&#xD;
      facial surfaces of defective RBC restorations with the medium series of aluminum oxide disks&#xD;
      (Sof-Lex,3M ESPE) or carbide burs (12 and 30 blades,Brasseler USA, Dental&#xD;
      Instrumentation,Savannah, Ga.) and then polished them with afine series of aluminum oxide&#xD;
      disks (Sof-Lex, 3M ESPE) and diamond-impregnated composite polisher (ComposiPro Diacomp,&#xD;
      Brasseler). For restorations in which proximal surface areas were affected, the clinicians&#xD;
      smoothed them with interproximal aluminum oxide finishing strips (Sof-Lex Finishing Strips,&#xD;
      3M ESPE).&#xD;
&#xD;
      Replacement group Composite resins with Alpha values for the marginal adaptation criteria&#xD;
      were used as the positive control and were made with resin composite (Filtek Supreme, 3M&#xD;
      ESPE), eith rubber dam isolation and the adhesive system L-Pop Prompt (3M-ESPE) No treatment&#xD;
      Composite resin restorations (Z100, 3M ESPE) in general clinically acceptable, did not&#xD;
      receive treatment.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>May 2003</start_date>
  <completion_date type="Actual">December 2013</completion_date>
  <primary_completion_date type="Actual">December 2013</primary_completion_date>
  <study_type>Observational [Patient Registry]</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Prospective</time_perspective>
  </study_design_info>
  <target_duration>10 Years</target_duration>
  <primary_outcome>
    <measure>Changes in quality of restorations</measure>
    <time_frame>1 year</time_frame>
    <description>The quality of the restorations was scored according to the modified USPHS criteria. Two examiners underwent calibration exercises each year (JM and EF). Immediately after the treatment (baseline) and 10 years later, the examiners assessed the restorations independently by direct visual and tactile examination with mouth mirror number 5 and explorer number 23 (Hu Friedy Mfg. Co. Inc., Chicago, IL, USA) and indirectly by radiographic examination (bite wing). The four parameters examined were anatomic form, secondary caries, marginal staining and marginal adaptation. If the difference was recorded between the two examiners, and if they could not reach an agreement, a third clinician, who also underwent the calibration exercises (GM), made the final decision.</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">25</enrollment>
  <condition>Unsatisfactory Restoration of Tooth</condition>
  <arm_group>
    <arm_group_label>Replacement</arm_group_label>
    <description>Composite resins with Alpha values for the marginal adaptation criteria were used as the positive control and were made with resin composite (Filtek Supreme, 3M ESPE), eith rubber dam isolation and the adhesive system L-Pop Prompt (3M-ESPE)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No treatment</arm_group_label>
    <description>Composite resin restorations (Z100, 3M ESPE) in general clinically acceptable, did not receive treatment.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Refurbishing</arm_group_label>
    <description>For this group, The dentists finished the occlusal, lingual or facial surfaces of defective RBC restorations with the medium series of aluminum oxide disks (Sof-Lex,3M ESPE) or carbide burs (12 and 30 blades,Brasseler USA, Dental Instrumentation,Savannah, Ga.) and then polished them with afine series of aluminum oxide disks (Sof-Lex, 3M ESPE) and diamond-impregnated composite polisher (ComposiPro Diacomp, Brasseler). For restorations in which proximal surface areas were affected, the clinicians smoothed them with interproximal aluminum oxide finishing strips (Sof-Lex Finishing Strips, 3M ESPE).</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        Any person with composite restorations&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with more than 20 teeth.&#xD;
&#xD;
          -  Restorations in functional occlusion, with an opposing natural tooth.&#xD;
&#xD;
          -  Asymptomatic restored tooth.&#xD;
&#xD;
          -  At least one proximal contact area with a neighboring tooth.&#xD;
&#xD;
          -  Patients older than 18 years.&#xD;
&#xD;
          -  Patients who agreed and signed a consent form for participating in the study.&#xD;
&#xD;
          -  Area outside of the restoration failure is in good condition.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with contra-indications for regular dental treatment based on their medical&#xD;
             history.&#xD;
&#xD;
          -  Patients with xerostomia or individuals taking medication that significantly decreased&#xD;
             salivary flow.&#xD;
&#xD;
          -  Patients with a high risk of caries.&#xD;
&#xD;
          -  Patients with psychiatric or physical diseases, which interfered with oral hygiene.&#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>eduardo fernandez</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Chile</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Eduardo Fernandez Godoy</name>
      <address>
        <city>Santiago</city>
        <zip>7500505</zip>
        <country>Chile</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Chile</country>
  </location_countries>
  <results_reference>
    <citation>Moncada G, Vildosola P, Fernandez E, Estay J, de Oliveira Junior OB, de Andrade MF, Martin J, Mjor IA, Gordan VV. Longitudinal results of a 10-year clinical trial of repair of amalgam restorations. Oper Dent. 2015 Jan-Feb;40(1):34-43. doi: 10.2341/14-045-C. Epub 2014 Aug 6.</citation>
    <PMID>25100406</PMID>
  </results_reference>
  <results_reference>
    <citation>Fernandez E, Martin J, Vildosola P, Oliveira Junior OB, Gordan V, Mjor I, Bersezio C, Estay J, de Andrade MF, Moncada G. Can repair increase the longevity of composite resins? Results of a 10-year clinical trial. J Dent. 2015 Feb;43(2):279-86. doi: 10.1016/j.jdent.2014.05.015. Epub 2014 Jun 4.</citation>
    <PMID>24907560</PMID>
  </results_reference>
  <verification_date>August 2014</verification_date>
  <study_first_submitted>August 19, 2014</study_first_submitted>
  <study_first_submitted_qc>August 20, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 21, 2014</study_first_posted>
  <last_update_submitted>August 20, 2014</last_update_submitted>
  <last_update_submitted_qc>August 20, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">August 21, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Chile</investigator_affiliation>
    <investigator_full_name>Eduardo Fernandez</investigator_full_name>
    <investigator_title>Eduardo Fernandez Godoy</investigator_title>
  </responsible_party>
  <keyword>composite</keyword>
  <keyword>dental</keyword>
  <keyword>longevity</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/NCT02222701
org study id: FOUCH2012/10-4
nct id: NCT02222701
lead sponsor: 
has dmc: Yes
The purpose of this study is to evaluate the clinical performance of resin composite
      restorations refurbished and compare with 2 groups of resins, 1 without treatment and another
      replaced resins acted as controls. The null hypothesis of this study is that the group of
      refurbished resins have a similar behavior to the control groups.
A cohort of 26 patients aged 18-80 years old (mean: 28.35 years; 42% men, 58% women) with 78
      composite restorations (Class I: 39; Class II: 39) were recruited at the Operative Dentistry
      Clinic at the Dental School of the University of Chile. All participants in the refurbishing
      groups showed clinical features for the anantomy, roughness and/or luster that deviated from
      the ideal and were rated Bravo according to the modified United States Public Health Service
      (USPHS) criteria. New Composites with Alpha values (Replacement group) and acceptable
      composites (No treatment group) were used as controls. The protocol was approved by the
      Institutional Research Ethics Committee of the Dental School at the University of Chile
      (Project PRI-ODO-0207). All patients signed informed-consent forms and completed registration
      forms

      General Inclusion Criteria:

        -  Patients with more than 20 teeth.

        -  Restorations in functional occlusion, with an opposing natural tooth.

        -  Asymptomatic restored tooth.

        -  At least one proximal contact area with a neighboring tooth.

        -  Patients older than 18 years.

        -  Patients who agreed and signed a consent form for participating in the study.

        -  Area outside of the restoration failure is in good condition.

      General Exclusion Criteria:

        -  Patients with contra-indications for regular dental treatment based on their medical
           history.

        -  Patients with xerostomia or individuals taking medication that significantly decreased
           salivary flow.

        -  Patients with a high risk of caries.

        -  Patients with psychiatric or physical diseases, which interfered with oral hygiene.

      Treatment Group Criteria Two hundred four patients were initially evaluated and assigned in
      accordance with the modified USPHS criteria,26 patients were selected based on the inclusion
      criteria with at least 1 Composite restoration with anatomy, roughness and/or luster (Bravo)
      suitable for reburbishing, with another composite restorations that had excellent values
      (Alpha) and was made at this time (Replacement group).And finally another composite
      pre-existing with acceptable condition (Alpha or Bravo values) acted as control. The patient
      was considered the statistical unit in this study (n=20).

      Restoration Assessment The quality of the restorations was scored in accordance with the
      modified USPHS criteria. The Cohen Kappa inter-examiner coefficient was 0.74 in the first
      year and 0.87 after 10 years for two examiners (JM and EF) who underwent calibration training
      exercises each year. In the first, second, third, fourth, fifth, and tenth years, the
      examiners independently assessed the restorations for anatomic form, roughness, color,
      marginal staining,luster, secondary caries, marginal and marginal adaptation, both directly
      via tactile and visual examinations with mouth mirror number five and explorer number 23 (Hu
      Friedy Mfg. Co. Inc.) and indirectly by radiographic examination (bite wing). A third
      clinician (GM), who also underwent the calibration training exercises, made the final
      decision if a difference was recorded between the two examiners and they could not reach an
      agreement.

      Treatment Groups Refurbishing For this group, The dentists finished the occlusal, lingual or
      facial surfaces of defective RBC restorations with the medium series of aluminum oxide disks
      (Sof-Lex,3M ESPE) or carbide burs (12 and 30 blades,Brasseler USA, Dental
      Instrumentation,Savannah, Ga.) and then polished them with afine series of aluminum oxide
      disks (Sof-Lex, 3M ESPE) and diamond-impregnated composite polisher (ComposiPro Diacomp,
      Brasseler). For restorations in which proximal surface areas were affected, the clinicians
      smoothed them with interproximal aluminum oxide finishing strips (Sof-Lex Finishing Strips,
      3M ESPE).

      Replacement group Composite resins with Alpha values for the marginal adaptation criteria
      were used as the positive control and were made with resin composite (Filtek Supreme, 3M
      ESPE), eith rubber dam isolation and the adhesive system L-Pop Prompt (3M-ESPE) No treatment
      Composite resin restorations (Z100, 3M ESPE) in general clinically acceptable, did not
      receive treatment.
observational model: Cohort
time perspective: Prospective
measure: Changes in quality of restorations
time frame: 1 year
description: The quality of the restorations was scored according to the modified USPHS criteria. Two examiners underwent calibration exercises each year (JM and EF). Immediately after the treatment (baseline) and 10 years later, the examiners assessed the restorations independently by direct visual and tactile examination with mouth mirror number 5 and explorer number 23 (Hu Friedy Mfg. Co. Inc., Chicago, IL, USA) and indirectly by radiographic examination (bite wing). The four parameters examined were anatomic form, secondary caries, marginal staining and marginal adaptation. If the difference was recorded between the two examiners, and if they could not reach an agreement, a third clinician, who also underwent the calibration exercises (GM), made the final decision.
arm group label: Replacement
description: Composite resins with Alpha values for the marginal adaptation criteria were used as the positive control and were made with resin composite (Filtek Supreme, 3M ESPE), eith rubber dam isolation and the adhesive system L-Pop Prompt (3M-ESPE)
arm group label: No treatment
description: Composite resin restorations (Z100, 3M ESPE) in general clinically acceptable, did not receive treatment.
arm group label: Refurbishing
description: For this group, The dentists finished the occlusal, lingual or facial surfaces of defective RBC restorations with the medium series of aluminum oxide disks (Sof-Lex,3M ESPE) or carbide burs (12 and 30 blades,Brasseler USA, Dental Instrumentation,Savannah, Ga.) and then polished them with afine series of aluminum oxide disks (Sof-Lex, 3M ESPE) and diamond-impregnated composite polisher (ComposiPro Diacomp, Brasseler). For restorations in which proximal surface areas were affected, the clinicians smoothed them with interproximal aluminum oxide finishing strips (Sof-Lex Finishing Strips, 3M ESPE).
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: eduardo fernandez
role: Principal Investigator
affiliation: University of Chile
facility: 
country: Chile
citation: Moncada G, Vildosola P, Fernandez E, Estay J, de Oliveira Junior OB, de Andrade MF, Martin J, Mjor IA, Gordan VV. Longitudinal results of a 10-year clinical trial of repair of amalgam restorations. Oper Dent. 2015 Jan-Feb;40(1):34-43. doi: 10.2341/14-045-C. Epub 2014 Aug 6.
PMID: 25100406
citation: Fernandez E, Martin J, Vildosola P, Oliveira Junior OB, Gordan V, Mjor I, Bersezio C, Estay J, de Andrade MF, Moncada G. Can repair increase the longevity of composite resins? Results of a 10-year clinical trial. J Dent. 2015 Feb;43(2):279-86. doi: 10.1016/j.jdent.2014.05.015. Epub 2014 Jun 4.
PMID: 24907560
responsible party type: Principal Investigator
investigator affiliation: University of Chile
investigator full name: Eduardo Fernandez
investigator title: Eduardo Fernandez Godoy