<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/NCT02975635</url>
  </required_header>
  <id_info>
    <org_study_id>Repair-Patients</org_study_id>
    <nct_id>NCT02975635</nct_id>
  </id_info>
  <brief_title>Patients' Preferences for Repair Versus Replacement Restorations</brief_title>
  <official_title>Patients' Preferences for Repair Versus Replacement Restorations</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Göttingen</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Georg-Elias-Mueller-Institute of Psychology, University Goettingen</agency>
      <agency_class>Other</agency_class>
    </collaborator>
    <collaborator>
      <agency>Charite University, Berlin, Germany</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Göttingen</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      Partially defective dental restorations might either be treated by complete replacement or by&#xD;
      repair of the affected region. Repair restorations are a scientifically proven approach to&#xD;
      manage failed restorations, but probably unknown to most patients. Results from this study&#xD;
      and findings on the predictors of patients' therapy decisions might improve future patient&#xD;
      information documents.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Handling insufficient restorations contributes up to 2/3 of all treatments in dentistry.&#xD;
      Formerly, defective restorations were completely removed and replaced. Today, repair&#xD;
      restorations are an alternative choice. During repair treatment, only the defective portion&#xD;
      of a restoration (instead of the complete restoration) is removed and replaced. By performing&#xD;
      repair restorations dental hard tissue can be conserved and the risk of treatment associated&#xD;
      complications is reduced.&#xD;
&#xD;
      Recent studies have shown that survival rates of repair restorations are slightly lower&#xD;
      compared to replacement fillings. Nevertheless, in certain clinical situations repair&#xD;
      restorations are more cost-effective than replacement.&#xD;
&#xD;
      Further studies have shown that patients' decisions differ with regard to a variety of&#xD;
      factors. This applies to decisions regarding dental treatments as well. However, patients'&#xD;
      decisions between both possible therapy options (repair or replacement) of partially&#xD;
      defective restorations are not yet investigated.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Active, not recruiting</last_known_status>
  <start_date type="Actual">March 15, 2017</start_date>
  <completion_date type="Anticipated">June 2021</completion_date>
  <primary_completion_date type="Anticipated">January 2021</primary_completion_date>
  <study_type>Observational</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>
  <primary_outcome>
    <measure>Completion of a questionnaire</measure>
    <time_frame>15 minutes</time_frame>
  </primary_outcome>
  <number_of_groups>2</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Patient Preference</condition>
  <arm_group>
    <arm_group_label>Oral patient information only</arm_group_label>
    <description>Patients are given oral information only (information as usual). After patients have made their decisions (repair or replacement), a questionnaire survey is conducted.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Written patient education before oral patient information</arm_group_label>
    <description>Patients are given a flow chart in advance of oral information. After patients have made their decisions (repair or replacement), a questionnaire survey is conducted.</description>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Questionnaire</intervention_name>
    <description>Patients are given a questionnaire with items related to personality and behaviour.</description>
    <arm_group_label>Oral patient information only</arm_group_label>
    <arm_group_label>Written patient education before oral patient information</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Department of Preventive Dentistry, Periodontology and Cariology, University Medical Center&#xD;
        Göttingen, Germany&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Participant are selected by consecutive patient sampling.&#xD;
&#xD;
        Inclusion Criteria:&#xD;
&#xD;
          -  At least one partially defective dental restoration which can either be repaired or&#xD;
             replaced&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-fulfillment of the inclusion criteria&#xD;
&#xD;
          -  Lack of capacity to consent&#xD;
&#xD;
          -  No German language skills in written and spoken language&#xD;
&#xD;
          -  Age &lt;18 years&#xD;
&#xD;
          -  Defective restoration must be completely replaced in any event or is not suitable for&#xD;
             repair&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Annette Wiegand, Prof. Dr. med. dent.</last_name>
    <role>Principal Investigator</role>
    <affiliation>Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>University Medical Center Göttingen, Dept. of Preventive Dentistry, Periodontology and Cariology</name>
      <address>
        <city>Göttingen</city>
        <state>Lower Saxony</state>
        <zip>37075</zip>
        <country>Germany</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Germany</country>
  </location_countries>
  <reference>
    <citation>Schwendicke F, Mostajaboldave R, Otto I, Dorfer CE, Burkert S. Patients' preferences for selective versus complete excavation: A mixed-methods study. J Dent. 2016 Mar;46:47-53. doi: 10.1016/j.jdent.2016.01.006. Epub 2016 Jan 18.</citation>
    <PMID>26796700</PMID>
  </reference>
  <reference>
    <citation>Weeks L, Balneaves LG, Paterson C, Verhoef M. Decision-making about complementary and alternative medicine by cancer patients: integrative literature review. Open Med. 2014 Apr 15;8(2):e54-66. eCollection 2014.</citation>
    <PMID>25009685</PMID>
  </reference>
  <reference>
    <citation>Ernst J, Brahler E, Weissflog G. [Patient involvement in medical decision making--an overview on patient preferences and impacting factors]. Gesundheitswesen. 2014 Apr;76(4):187-92. doi: 10.1055/s-0033-1361150. Epub 2014 Jan 9. German.</citation>
    <PMID>24408309</PMID>
  </reference>
  <reference>
    <citation>Kanzow P, Hoffmann R, Tschammler C, Kruppa J, Rodig T, Wiegand A. Attitudes, practice, and experience of German dentists regarding repair restorations. Clin Oral Investig. 2017 May;21(4):1087-1093. doi: 10.1007/s00784-016-1859-3. Epub 2016 Jun 2.</citation>
    <PMID>27255959</PMID>
  </reference>
  <reference>
    <citation>Kanzow P, Wiegand A, Schwendicke F. Cost-effectiveness of repairing versus replacing composite or amalgam restorations. J Dent. 2016 Nov;54:41-47. doi: 10.1016/j.jdent.2016.08.008. Epub 2016 Aug 26.</citation>
    <PMID>27575986</PMID>
  </reference>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>November 23, 2016</study_first_submitted>
  <study_first_submitted_qc>November 23, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">November 29, 2016</study_first_posted>
  <last_update_submitted>November 4, 2020</last_update_submitted>
  <last_update_submitted_qc>November 4, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 5, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University Medical Center Goettingen</investigator_affiliation>
    <investigator_full_name>Philipp Kanzow, Dr. med. dent., Dr. rer. medic.</investigator_full_name>
    <investigator_title>Dr. med. dent.</investigator_title>
  </responsible_party>
  <keyword>Patients' Preferences</keyword>
  <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/NCT02975635
org study id: Repair-Patients
nct id: NCT02975635
lead sponsor: 
collaborator: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Partially defective dental restorations might either be treated by complete replacement or by
      repair of the affected region. Repair restorations are a scientifically proven approach to
      manage failed restorations, but probably unknown to most patients. Results from this study
      and findings on the predictors of patients' therapy decisions might improve future patient
      information documents.
Handling insufficient restorations contributes up to 2/3 of all treatments in dentistry.
      Formerly, defective restorations were completely removed and replaced. Today, repair
      restorations are an alternative choice. During repair treatment, only the defective portion
      of a restoration (instead of the complete restoration) is removed and replaced. By performing
      repair restorations dental hard tissue can be conserved and the risk of treatment associated
      complications is reduced.

      Recent studies have shown that survival rates of repair restorations are slightly lower
      compared to replacement fillings. Nevertheless, in certain clinical situations repair
      restorations are more cost-effective than replacement.

      Further studies have shown that patients' decisions differ with regard to a variety of
      factors. This applies to decisions regarding dental treatments as well. However, patients'
      decisions between both possible therapy options (repair or replacement) of partially
      defective restorations are not yet investigated.
observational model: Cohort
time perspective: Prospective
measure: Completion of a questionnaire
time frame: 15 minutes
arm group label: Oral patient information only
description: Patients are given oral information only (information as usual). After patients have made their decisions (repair or replacement), a questionnaire survey is conducted.
arm group label: Written patient education before oral patient information
description: Patients are given a flow chart in advance of oral information. After patients have made their decisions (repair or replacement), a questionnaire survey is conducted.
intervention type: Other
intervention name: Questionnaire
description: Patients are given a questionnaire with items related to personality and behaviour.
arm group label: Oral patient information only
arm group label: Written patient education before oral patient information
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Annette Wiegand, Prof. Dr. med. dent.
role: Principal Investigator
affiliation: Dept. of Prev. Dentistry, Periodontology and Cariology, University Medical Center Göttingen, Germany
facility: 
country: Germany
citation: Schwendicke F, Mostajaboldave R, Otto I, Dorfer CE, Burkert S. Patients' preferences for selective versus complete excavation: A mixed-methods study. J Dent. 2016 Mar;46:47-53. doi: 10.1016/j.jdent.2016.01.006. Epub 2016 Jan 18.
PMID: 26796700
citation: Weeks L, Balneaves LG, Paterson C, Verhoef M. Decision-making about complementary and alternative medicine by cancer patients: integrative literature review. Open Med. 2014 Apr 15;8(2):e54-66. eCollection 2014.
PMID: 25009685
citation: Ernst J, Brahler E, Weissflog G. [Patient involvement in medical decision making--an overview on patient preferences and impacting factors]. Gesundheitswesen. 2014 Apr;76(4):187-92. doi: 10.1055/s-0033-1361150. Epub 2014 Jan 9. German.
PMID: 24408309
citation: Kanzow P, Hoffmann R, Tschammler C, Kruppa J, Rodig T, Wiegand A. Attitudes, practice, and experience of German dentists regarding repair restorations. Clin Oral Investig. 2017 May;21(4):1087-1093. doi: 10.1007/s00784-016-1859-3. Epub 2016 Jun 2.
PMID: 27255959
citation: Kanzow P, Wiegand A, Schwendicke F. Cost-effectiveness of repairing versus replacing composite or amalgam restorations. J Dent. 2016 Nov;54:41-47. doi: 10.1016/j.jdent.2016.08.008. Epub 2016 Aug 26.
PMID: 27575986
responsible party type: Principal Investigator
investigator affiliation: University Medical Center Goettingen
investigator full name: Philipp Kanzow, Dr. med. dent., Dr. rer. medic.
investigator title: Dr. med. dent.
sharing ipd: No