<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/NCT03816930</url>
  </required_header>
  <id_info>
    <org_study_id>05</org_study_id>
    <nct_id>NCT03816930</nct_id>
  </id_info>
  <brief_title>Evaluation of Gingival Health Parameters in Hybrid CAD / CAM Crowns Produced After Different Retraction Processes</brief_title>
  <official_title>Evaluation of Gingival Health Parameters in Hybrid CAD / CAM Crowns Produced After Different Retraction Processes</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Yuzuncu Yıl University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Yuzuncu Yıl University</source>
  <oversight_info>
    <has_dmc>Yes</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>
      Clinically, the gingival retraction dentistry itself has found wide uses. It has achieved the&#xD;
      use of subgingival and gingival crowns in fixed prostheses, cervical abrasion in restorative&#xD;
      dentistry, management of root caries and root sensitivity, and recently in the use of&#xD;
      appropriate measurements to improve the marginal fit of implant prostheses.There are three&#xD;
      different retraction procedures described in the literature: mechanical, mechanical-chemical&#xD;
      (chemically impregnated cords or matrix in injectable form) and surgery (electrosurgical,&#xD;
      laser, cauterization, etc.)The mechanical method of retraction cords is not always suitable&#xD;
      for patients' existing pocket depth, the necessity of using different combinations in shallow&#xD;
      or deep pockets, the potential for limited bleeding control in chemically impregnated cords&#xD;
      and the toxicity values in those who interact with chemical have led researchers to search&#xD;
      for alternative methods. Especially inflammed gingiva is very sensitive to mechanical and&#xD;
      chemical trauma. Studies have reported that gingival inflammation, pain, pocket formation,&#xD;
      gingival withdrawal, increased bleeding and wound contamination occurred following retraction&#xD;
      cord application. However, it is a known fact that the impression material is distorted or&#xD;
      the accuracy of the measurement is decreased with the measurements taken without retraction.&#xD;
      Nowadays, CAD / CAM (computer-aided design / computer-aided manufacturing) devices, which are&#xD;
      designed to overcome these problems and eliminate the errors related to the measurement&#xD;
      material, are the first step to be taken with a clear measure.Gingival retraction is&#xD;
      recommended to improve the success of scanners in all restorations performed at the gingival&#xD;
      or subgingival endpoint. Therefore, in our study, crown restorations will be produced from&#xD;
      hybrid blocks by means of CAD / CAM device in order to evaluate the interaction of gingival&#xD;
      health with hybrid blocks and to provide the latest technology and standardization.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">January 17, 2019</start_date>
  <completion_date type="Actual">April 17, 2020</completion_date>
  <primary_completion_date type="Actual">January 17, 2020</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>Other</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Retraction methods or procedures effects on gingival health</measure>
    <time_frame>3-12 months</time_frame>
    <description>Probing depth is one of the criteria that shows the gingival health. In each control sessions same researcher measure the probing depth as mm via a periodontal probe.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">52</enrollment>
  <condition>Periodontal Disease</condition>
  <condition>Gingival Disease</condition>
  <arm_group>
    <arm_group_label>Mechanical cord usage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Mechanical retraction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chemical contained retraction usage</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Chemical retraction</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MZ-6 laser tip used throughing</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Laser retraction</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>mechanical cord usage</intervention_name>
    <description>Due to the retraction procedures, same preparation conditions will be obtained.</description>
    <arm_group_label>Chemical contained retraction usage</arm_group_label>
    <arm_group_label>MZ-6 laser tip used throughing</arm_group_label>
    <arm_group_label>Mechanical cord usage</arm_group_label>
    <other_name>Chemical contained retraction usage</other_name>
    <other_name>MZ-6 laser tip used throughing</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Being systemically healthy&#xD;
&#xD;
          -  To indicate crown restoration in mandibular molar teeth&#xD;
&#xD;
          -  To be vital to the preparation of the crown of the teeth&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Systemically unhealthy individuals&#xD;
&#xD;
          -  Endodontic treatment of mandibular molar teeth&#xD;
&#xD;
          -  Mandibular molar female individuals drawn for various reasons&#xD;
&#xD;
          -  Pregnant women&#xD;
&#xD;
          -  Periodontally unhealthy individuals&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>60 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>Beyza Ünalan Değirmenci</name>
      <address>
        <city>Van</city>
        <zip>65080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <results_reference>
    <citation>Padbury A Jr, Eber R, Wang HL. Interactions between the gingiva and the margin of restorations. J Clin Periodontol. 2003 May;30(5):379-85. doi: 10.1034/j.1600-051x.2003.01277.x.</citation>
    <PMID>12716328</PMID>
  </results_reference>
  <results_reference>
    <citation>Al-Ani A, Bennani V, Chandler NP, Lyons KM, Thomson WM. New Zealand dentists' use of gingival retraction techniques for fixed prosthodontics and implants. N Z Dent J. 2010 Sep;106(3):92-6.</citation>
    <PMID>20882737</PMID>
  </results_reference>
  <results_reference>
    <citation>Goldberg PV, Higginbottom FL, Wilson TG. Periodontal considerations in restorative and implant therapy. Periodontol 2000. 2001;25:100-9. doi: 10.1034/j.1600-0757.2001.22250108.x.</citation>
    <PMID>11155185</PMID>
  </results_reference>
  <results_reference>
    <citation>Kopac I, Cvetko E, Marion L. Gingival inflammatory response induced by chemical retraction agents in beagle dogs. Int J Prosthodont. 2002 Jan-Feb;15(1):14-9.</citation>
    <PMID>11887594</PMID>
  </results_reference>
  <results_reference>
    <citation>Polat NT, Ozdemir AK, Turgut M. Effects of gingival retraction materials on gingival blood flow. Int J Prosthodont. 2007 Jan-Feb;20(1):57-62.</citation>
    <PMID>17319365</PMID>
  </results_reference>
  <results_reference>
    <citation>Ferrari M, Cagidiaco MC, Ercoli C. Tissue management with a new gingival retraction material: a preliminary clinical report. J Prosthet Dent. 1996 Mar;75(3):242-7. doi: 10.1016/s0022-3913(96)90479-5.</citation>
    <PMID>8648569</PMID>
  </results_reference>
  <results_reference>
    <citation>de Gennaro GG, Landesman HM, Calhoun JE, Martinoff JT. A comparison of gingival inflammation related to retraction cords. J Prosthet Dent. 1982 Apr;47(4):384-6. doi: 10.1016/s0022-3913(82)80085-1.</citation>
    <PMID>6951037</PMID>
  </results_reference>
  <results_reference>
    <citation>Ahmed SN, Donovan TE. Gingival displacement: Survey results of dentists' practice procedures. J Prosthet Dent. 2015 Jul;114(1):81-5.e1-2. doi: 10.1016/j.prosdent.2014.11.015. Epub 2015 Apr 24.</citation>
    <PMID>25917854</PMID>
  </results_reference>
  <verification_date>April 2021</verification_date>
  <study_first_submitted>January 17, 2019</study_first_submitted>
  <study_first_submitted_qc>January 23, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 25, 2019</study_first_posted>
  <last_update_submitted>April 21, 2021</last_update_submitted>
  <last_update_submitted_qc>April 21, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">April 22, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yuzuncu Yıl University</investigator_affiliation>
    <investigator_full_name>Beyza Ünalan Değirmenci</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>CAD/CAM</keyword>
  <keyword>Gingival retraction</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</mesh_term>
    <mesh_term>Gingival Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03816930
org study id: 05
nct id: NCT03816930
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Clinically, the gingival retraction dentistry itself has found wide uses. It has achieved the
      use of subgingival and gingival crowns in fixed prostheses, cervical abrasion in restorative
      dentistry, management of root caries and root sensitivity, and recently in the use of
      appropriate measurements to improve the marginal fit of implant prostheses.There are three
      different retraction procedures described in the literature: mechanical, mechanical-chemical
      (chemically impregnated cords or matrix in injectable form) and surgery (electrosurgical,
      laser, cauterization, etc.)The mechanical method of retraction cords is not always suitable
      for patients' existing pocket depth, the necessity of using different combinations in shallow
      or deep pockets, the potential for limited bleeding control in chemically impregnated cords
      and the toxicity values in those who interact with chemical have led researchers to search
      for alternative methods. Especially inflammed gingiva is very sensitive to mechanical and
      chemical trauma. Studies have reported that gingival inflammation, pain, pocket formation,
      gingival withdrawal, increased bleeding and wound contamination occurred following retraction
      cord application. However, it is a known fact that the impression material is distorted or
      the accuracy of the measurement is decreased with the measurements taken without retraction.
      Nowadays, CAD / CAM (computer-aided design / computer-aided manufacturing) devices, which are
      designed to overcome these problems and eliminate the errors related to the measurement
      material, are the first step to be taken with a clear measure.Gingival retraction is
      recommended to improve the success of scanners in all restorations performed at the gingival
      or subgingival endpoint. Therefore, in our study, crown restorations will be produced from
      hybrid blocks by means of CAD / CAM device in order to evaluate the interaction of gingival
      health with hybrid blocks and to provide the latest technology and standardization.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: None (Open Label)
measure: Retraction methods or procedures effects on gingival health
time frame: 3-12 months
description: Probing depth is one of the criteria that shows the gingival health. In each control sessions same researcher measure the probing depth as mm via a periodontal probe.
arm group label: Mechanical cord usage
arm group type: Active Comparator
description: Mechanical retraction
arm group label: Chemical contained retraction usage
arm group type: Active Comparator
description: Chemical retraction
arm group label: MZ-6 laser tip used throughing
arm group type: Active Comparator
description: Laser retraction
intervention type: Procedure
intervention name: mechanical cord usage
description: Due to the retraction procedures, same preparation conditions will be obtained.
arm group label: Chemical contained retraction usage
arm group label: MZ-6 laser tip used throughing
arm group label: Mechanical cord usage
other name: Chemical contained retraction usage
other name: MZ-6 laser tip used throughing
criteria: 
gender: All
minimum age: 18 Years
maximum age: 60 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Turkey
citation: Padbury A Jr, Eber R, Wang HL. Interactions between the gingiva and the margin of restorations. J Clin Periodontol. 2003 May;30(5):379-85. doi: 10.1034/j.1600-051x.2003.01277.x.
PMID: 12716328
citation: Al-Ani A, Bennani V, Chandler NP, Lyons KM, Thomson WM. New Zealand dentists' use of gingival retraction techniques for fixed prosthodontics and implants. N Z Dent J. 2010 Sep;106(3):92-6.
PMID: 20882737
citation: Goldberg PV, Higginbottom FL, Wilson TG. Periodontal considerations in restorative and implant therapy. Periodontol 2000. 2001;25:100-9. doi: 10.1034/j.1600-0757.2001.22250108.x.
PMID: 11155185
citation: Kopac I, Cvetko E, Marion L. Gingival inflammatory response induced by chemical retraction agents in beagle dogs. Int J Prosthodont. 2002 Jan-Feb;15(1):14-9.
PMID: 11887594
citation: Polat NT, Ozdemir AK, Turgut M. Effects of gingival retraction materials on gingival blood flow. Int J Prosthodont. 2007 Jan-Feb;20(1):57-62.
PMID: 17319365
citation: Ferrari M, Cagidiaco MC, Ercoli C. Tissue management with a new gingival retraction material: a preliminary clinical report. J Prosthet Dent. 1996 Mar;75(3):242-7. doi: 10.1016/s0022-3913(96)90479-5.
PMID: 8648569
citation: de Gennaro GG, Landesman HM, Calhoun JE, Martinoff JT. A comparison of gingival inflammation related to retraction cords. J Prosthet Dent. 1982 Apr;47(4):384-6. doi: 10.1016/s0022-3913(82)80085-1.
PMID: 6951037
citation: Ahmed SN, Donovan TE. Gingival displacement: Survey results of dentists' practice procedures. J Prosthet Dent. 2015 Jul;114(1):81-5.e1-2. doi: 10.1016/j.prosdent.2014.11.015. Epub 2015 Apr 24.
PMID: 25917854
responsible party type: Principal Investigator
investigator affiliation: Yuzuncu Yıl University
investigator full name: Beyza Ünalan Değirmenci
investigator title: Assistant Professor
mesh term: Periodontal Diseases
mesh term: Gingival Diseases
sharing ipd: Undecided