<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/NCT03295604</url>
  </required_header>
  <id_info>
    <org_study_id>YuzuncuYıl 3</org_study_id>
    <nct_id>NCT03295604</nct_id>
  </id_info>
  <brief_title>A Novel Volumetric Analysis Using CAD/CAM Scanners in Gingival Recession Treatment</brief_title>
  <official_title>A Novel Volumetric Analysis Using CAD/CAM Scanners in Gingival Recession</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Hacer Sahin Aydinyurt</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Yuzuncu Yıl University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>Yuzuncu Yıl University</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>
      Aim: In this ramdomised clinical trial (RCT), the aim was to compare clinical periodontal&#xD;
      data of subepithelial connective tissue graft (SCTG) group and SCGT+enamel matrix derivatives&#xD;
      (EMD) group in terms of gained gingiva volume (GGV) and gained gingiva surface area (GGSA) by&#xD;
      scanners of computer-aided design/computer-aided manufacturing (CAD/CAM) devices.&#xD;
&#xD;
      Materials and Methods: A total of 35 Miller class I-II gingival recession defects were&#xD;
      involved in this study (n=17 in SCTG group, n=18 in SCTG+EMD group). In addition to&#xD;
      periodontal clinical parameters, three dimensional (3D) images were recorded using CAD/CAM&#xD;
      system before the treatment, at the 1st month and at the 6th months after the treatment. The&#xD;
      images were superimposed using softwares and GGV, GGSA were calculated.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Study populations:&#xD;
&#xD;
      In this study, totally 35 gingival recession (GR) defects in 35 patients, who applied with&#xD;
      complaints of poor aesthetic and/or root surface sensitivity. Following patients were&#xD;
      admitted to the study: individuals should have no systemic disease, should be non-smokers of&#xD;
      cigarette or tobacco products, not in a pregnancy, have not used any antibiotics or&#xD;
      medications with an impact on the immune system within last 6 months, have GR classified as&#xD;
      Miller class I or class II, have GR depth of ≥2mm , have no decay or restoration on the vital&#xD;
      teeth which will be operated, have no operation history with regard to GRs for related tooth&#xD;
      area. The materials and methods of this study were approved by the Non-Drug Clinical&#xD;
      Researches Ethics Committee of Yüzüncü Yıl University (B.30.2.YYU.0.01.00.00/32).&#xD;
&#xD;
      Study Groups:&#xD;
&#xD;
      In SCTG group 17 of GRs defects and in SCTG+EMD group 18 GRs defects were treated. While GRs&#xD;
      in SCTG group was treated by SCTG and CPF combination therapy, EMD (Emdogain, Straumann,&#xD;
      Basel, Switzerland) was additionally used in GR treatments of SCTG+EMD group. Patients were&#xD;
      randomized by complete randomization method (SPSS 15; SPSS Inc., Chicago, IL, USA) to assign&#xD;
      them into groups.&#xD;
&#xD;
      Pre-surgical Procedure:&#xD;
&#xD;
      Patients were informed about the potential causes of GRs. Causative habits of GR have been&#xD;
      eliminated. Baseline periodontal treatments of the patients were performed. Plaque index (PI)&#xD;
      , gingival index (GI) , probing pocket depth (PPD) (mm), clinical attachment level (CAL) (mm)&#xD;
      were recorded before periodontal treatment. We prepared patients with total PI scores less&#xD;
      than 15% for the surgical procedure (O'Leary et al 1972). Pre-treatment 3D soft tissue images&#xD;
      were taken by CEREC Omnicam (Sirona Dental Systems GmbH, Bensheim, Germany) from intra-oral&#xD;
      region. Recipient zone was prepared using the Langer method. SCTG was extracted ipsilaterally&#xD;
      with the operation site from the palatal region between distal of canine and mesial of 1st&#xD;
      molar tooth. Incision was performed in parallel with free gingival margin using Harris graft&#xD;
      knife (Harris Double Blade Graft Knife, H &amp; H Company, Ontario, CA, USA). Harvested graft was&#xD;
      implanted to recipient zone so that its periosteal side faces with root surface and overhangs&#xD;
      defect borders by 1mm. In order to remove the smear layer on the root surface of the teeth in&#xD;
      SCTG+EMD group, 24% EDTA (Prefgel, Straumann, Basel, Switzerland) was applied for two minutes&#xD;
      onto the root surface and operation site was washed with normal saline in order to remove any&#xD;
      residual EDTA. EMD was applied to entire root surface compatible with manufacturer's&#xD;
      instructions .&#xD;
&#xD;
      Post-surgical Procedure:&#xD;
&#xD;
      3D images and clinical parameter values were recorded during follow-up examinations at the&#xD;
      1st and the 6th month after the periodontal surgery. 3D images of soft tissue were taken&#xD;
      intraorally with CEREC Omnicam® device at the commencement of treatment as well as at the&#xD;
      post-operative 1st and 6th months . The measurements were recorded as in rst.img format which&#xD;
      is a file extension of CEREC system®. The operation site was cut out from the image which was&#xD;
      recorded at the 1st and at the 6th month. Images of each patient which were taken in three&#xD;
      different time points were overlapped on Mimics 10 software. GGV and GGSA measurements were&#xD;
      made on the overlapped images. the GGV and GGSA were calculated the difference in tissue as&#xD;
      obtained after overlapping the 3D images by the software. Changes at the 1st and the 6th&#xD;
      month after treatment were calculated with respect to pre-treatment images .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">April 2014</start_date>
  <completion_date type="Actual">December 2014</completion_date>
  <primary_completion_date type="Actual">November 2014</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>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>GGV</measure>
    <time_frame>6 months</time_frame>
    <description>Gingival gain volume: measured by software on images (mm3)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>GGSA</measure>
    <time_frame>6 months</time_frame>
    <description>Gingival gain of surface area: measured by software on images (mm2</description>
  </primary_outcome>
  <primary_outcome>
    <measure>GRH</measure>
    <time_frame>6 months</time_frame>
    <description>gingival recession height: the distance between cementoenamel junction to gingival margin (mm)</description>
  </primary_outcome>
  <primary_outcome>
    <measure>GRW</measure>
    <time_frame>6 months</time_frame>
    <description>gingival recession width: the distance between mesial and distal gingival margins (mm)</description>
  </primary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">35</enrollment>
  <condition>Gingival Recession</condition>
  <arm_group>
    <arm_group_label>test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Miller class I-II gingival recession defects operated with sub epithelial connective tissue graft (SCTG) in addition with enamel matrix derivatives (EMD) (Emdogain ®, Switzerland ) in SCTG+EMD group.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Miller class I-II gingival recession defects operated with only sub epithelial connective tissue graft (SCTG). No drug or something else were used</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SCTG+EMD</intervention_name>
    <description>Miller class I-II gingival recession defects were operated with SCTG+EMD</description>
    <arm_group_label>test group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>SCTG</intervention_name>
    <description>Miller class I-II gingival recession defects were operated with SCTG only and</description>
    <arm_group_label>control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  individuals should have no systemic disease&#xD;
&#xD;
          -  non-smokers of cigarette or tobacco products&#xD;
&#xD;
          -  not in a pregnancy,&#xD;
&#xD;
          -  have not used any antibiotics or medications with an impact on the immune system&#xD;
             within last 6 months,&#xD;
&#xD;
          -  have GR classified as Miller class I or class II&#xD;
&#xD;
          -  have GR depth of ≥2mm ,&#xD;
&#xD;
          -  have no decay or restoration on the vital teeth which will be operated&#xD;
&#xD;
          -  have no operation history with regard to GRs for related tooth area.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  smoking&#xD;
&#xD;
          -  Miller class III and IV gingival recession&#xD;
&#xD;
          -  antibiotic use&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <verification_date>September 2017</verification_date>
  <study_first_submitted>August 16, 2017</study_first_submitted>
  <study_first_submitted_qc>September 24, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">September 28, 2017</study_first_posted>
  <last_update_submitted>September 24, 2017</last_update_submitted>
  <last_update_submitted_qc>September 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">September 28, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Yuzuncu Yıl University</investigator_affiliation>
    <investigator_full_name>Hacer Sahin Aydinyurt</investigator_full_name>
    <investigator_title>assistant professor</investigator_title>
  </responsible_party>
  <keyword>Gingival recession</keyword>
  <keyword>Subepithelial connective tissue grafts</keyword>
  <keyword>CAD/CAM</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingival Recession</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/NCT03295604
org study id: YuzuncuYıl 3
nct id: NCT03295604
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Aim: In this ramdomised clinical trial (RCT), the aim was to compare clinical periodontal
      data of subepithelial connective tissue graft (SCTG) group and SCGT+enamel matrix derivatives
      (EMD) group in terms of gained gingiva volume (GGV) and gained gingiva surface area (GGSA) by
      scanners of computer-aided design/computer-aided manufacturing (CAD/CAM) devices.

      Materials and Methods: A total of 35 Miller class I-II gingival recession defects were
      involved in this study (n=17 in SCTG group, n=18 in SCTG+EMD group). In addition to
      periodontal clinical parameters, three dimensional (3D) images were recorded using CAD/CAM
      system before the treatment, at the 1st month and at the 6th months after the treatment. The
      images were superimposed using softwares and GGV, GGSA were calculated.
Study populations:

      In this study, totally 35 gingival recession (GR) defects in 35 patients, who applied with
      complaints of poor aesthetic and/or root surface sensitivity. Following patients were
      admitted to the study: individuals should have no systemic disease, should be non-smokers of
      cigarette or tobacco products, not in a pregnancy, have not used any antibiotics or
      medications with an impact on the immune system within last 6 months, have GR classified as
      Miller class I or class II, have GR depth of ≥2mm , have no decay or restoration on the vital
      teeth which will be operated, have no operation history with regard to GRs for related tooth
      area. The materials and methods of this study were approved by the Non-Drug Clinical
      Researches Ethics Committee of Yüzüncü Yıl University (B.30.2.YYU.0.01.00.00/32).

      Study Groups:

      In SCTG group 17 of GRs defects and in SCTG+EMD group 18 GRs defects were treated. While GRs
      in SCTG group was treated by SCTG and CPF combination therapy, EMD (Emdogain, Straumann,
      Basel, Switzerland) was additionally used in GR treatments of SCTG+EMD group. Patients were
      randomized by complete randomization method (SPSS 15; SPSS Inc., Chicago, IL, USA) to assign
      them into groups.

      Pre-surgical Procedure:

      Patients were informed about the potential causes of GRs. Causative habits of GR have been
      eliminated. Baseline periodontal treatments of the patients were performed. Plaque index (PI)
      , gingival index (GI) , probing pocket depth (PPD) (mm), clinical attachment level (CAL) (mm)
      were recorded before periodontal treatment. We prepared patients with total PI scores less
      than 15% for the surgical procedure (O'Leary et al 1972). Pre-treatment 3D soft tissue images
      were taken by CEREC Omnicam (Sirona Dental Systems GmbH, Bensheim, Germany) from intra-oral
      region. Recipient zone was prepared using the Langer method. SCTG was extracted ipsilaterally
      with the operation site from the palatal region between distal of canine and mesial of 1st
      molar tooth. Incision was performed in parallel with free gingival margin using Harris graft
      knife (Harris Double Blade Graft Knife, H & H Company, Ontario, CA, USA). Harvested graft was
      implanted to recipient zone so that its periosteal side faces with root surface and overhangs
      defect borders by 1mm. In order to remove the smear layer on the root surface of the teeth in
      SCTG+EMD group, 24% EDTA (Prefgel, Straumann, Basel, Switzerland) was applied for two minutes
      onto the root surface and operation site was washed with normal saline in order to remove any
      residual EDTA. EMD was applied to entire root surface compatible with manufacturer's
      instructions .

      Post-surgical Procedure:

      3D images and clinical parameter values were recorded during follow-up examinations at the
      1st and the 6th month after the periodontal surgery. 3D images of soft tissue were taken
      intraorally with CEREC Omnicam® device at the commencement of treatment as well as at the
      post-operative 1st and 6th months . The measurements were recorded as in rst.img format which
      is a file extension of CEREC system®. The operation site was cut out from the image which was
      recorded at the 1st and at the 6th month. Images of each patient which were taken in three
      different time points were overlapped on Mimics 10 software. GGV and GGSA measurements were
      made on the overlapped images. the GGV and GGSA were calculated the difference in tissue as
      obtained after overlapping the 3D images by the software. Changes at the 1st and the 6th
      month after treatment were calculated with respect to pre-treatment images .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: GGV
time frame: 6 months
description: Gingival gain volume: measured by software on images (mm3)
measure: GGSA
time frame: 6 months
description: Gingival gain of surface area: measured by software on images (mm2
measure: GRH
time frame: 6 months
description: gingival recession height: the distance between cementoenamel junction to gingival margin (mm)
measure: GRW
time frame: 6 months
description: gingival recession width: the distance between mesial and distal gingival margins (mm)
arm group label: test group
arm group type: Experimental
description: Miller class I-II gingival recession defects operated with sub epithelial connective tissue graft (SCTG) in addition with enamel matrix derivatives (EMD) (Emdogain ®, Switzerland ) in SCTG+EMD group.
arm group label: control group
arm group type: Experimental
description: Miller class I-II gingival recession defects operated with only sub epithelial connective tissue graft (SCTG). No drug or something else were used
intervention type: Procedure
intervention name: SCTG+EMD
description: Miller class I-II gingival recession defects were operated with SCTG+EMD
arm group label: test group
intervention type: Procedure
intervention name: SCTG
description: Miller class I-II gingival recession defects were operated with SCTG only and
arm group label: control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: No
responsible party type: Sponsor-Investigator
investigator affiliation: Yuzuncu Yıl University
investigator full name: Hacer Sahin Aydinyurt
investigator title: assistant professor
mesh term: Gingival Recession
sharing ipd: Undecided