<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/NCT03020732</url>
  </required_header>
  <id_info>
    <org_study_id>03/2011-16</org_study_id>
    <nct_id>NCT03020732</nct_id>
  </id_info>
  <brief_title>Gingival Recession Treatment With Concentrated Growth Factor(CGF)</brief_title>
  <official_title>Concentrated Growth Factor Membrane Versus Subepithelial Connective Tissue Grafts in Treatment of Multiple Gingival Recession Defects: a Split-mouth Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Gazi University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Gazi University</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Platelet concentrates(PC) are used in the field of periodontology and implantology for the&#xD;
      content necessary key cells and growth factors to accelerate healing and to provide&#xD;
      regeneration. Concentrated Growth Factors(CGF) is defined as an innovative method or a new&#xD;
      generation PC. The purpose of this clinical study was to evaluate the clinical effectiveness&#xD;
      of Concentrated Growth Factor(CGF) membrane with coronally advanced flap(CAF) procedure's and&#xD;
      subepithelial connective tissue graft(SCTG) with CAF in the treatment of Miller class I&#xD;
      gingival recessions (GR).&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      CGF is defined as an innovative method to produce platelet rich fibrin(PRF) or a new&#xD;
      generation platelet concentrate(PC).The rotational speed of the centrifuge machine used in&#xD;
      CGF, varies between 2400-3000 rpm. The variability of the rotation speed during&#xD;
      centrifugation allows a fibrin matrix that larger, more intensive and includes more growth&#xD;
      factors than PRF. Some studies have been reported that CGF have an inducing effect on&#xD;
      periodontal ligament stem cells for osteogenic differentiation and clinically provides new&#xD;
      bone formation for the sinus augmentation. In literature, there is only one clinical research&#xD;
      associated with multiple gingival recession defects treatment. It showed that CGF with CAF&#xD;
      surgery increases keratinized gingiva weight and thickness and it maybe prevents&#xD;
      post-operative relapse for CAF.&#xD;
&#xD;
      PC has also been mentioned to be effective in to increase the width of keratinized tissue&#xD;
      with providing root coverage and it may reduce early post-surgical complications, and&#xD;
      accelerate wound healing in systematic review. In the treatment of isolated or multiple&#xD;
      gingival recession, PRF and SCTG with CAF procedures have been reported to similar root&#xD;
      coverage. PRF can be used as an alternative method for SCTG .CGF and PRF have similar&#xD;
      composition. However higher resistance and viscosity of CGF may protect growth factors from&#xD;
      proteolysis better than PRF. There is any comparative study for CGF and SCTG in literature in&#xD;
      terms of clinically or patient related parameters.&#xD;
&#xD;
      Therefore, the purpose of this clinical study is to evaluate the clinical efficacy of CGF in&#xD;
      combination with CAF in the treatment of gingival recession's defects, and to compare SCTG in&#xD;
      combination with CAF. It is also aimed to asses and compare postoperative pain and soft&#xD;
      tissue healing.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>February 2013</start_date>
  <completion_date type="Actual">February 2014</completion_date>
  <primary_completion_date type="Actual">February 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>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>recession depth</measure>
    <time_frame>change from baseline at following surgery first, third and sixth month respectively</time_frame>
    <description>recession depth was measured distance from cemento-enamel junction(CEJ) to the gingival margin, using periodontal probe at the mid-facial surface and rounded to the nearest millimeters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>root coverage</measure>
    <time_frame>change from baseline at following surgery first, third and sixth month respectively</time_frame>
    <description>Root coverage(RC) was calculated for multiple recession defects groups with a formula.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>keratinized tissue thickness</measure>
    <time_frame>change from baseline at following surgery first, third and sixth month respectively</time_frame>
    <description>Keratinized tissue thickness(KTT) value was obtained from a digital caliper with the accuracy of 0.01 mm and using a 15 endodontic reamer, on mid-point localization of keratinized tissue or the alveolar mucosa, at level bottom of the gingival crevice.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>keratinized tissue weight</measure>
    <time_frame>change from baseline at following surgery first, third and sixth month respectively</time_frame>
    <description>keratinized tissue weight was measured distance from the free gingival margin to the mucogingival junction, using periodontal probe at the mid-facial surface and rounded to the nearest millimeters.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>clinical attachment level</measure>
    <time_frame>change from baseline at following surgery first, third and sixth month respectively</time_frame>
    <description>clinical attachment level was mesured distance from CEJ to the bottom of the gingival crevice</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>wound healing</measure>
    <time_frame>after surgery first, second and third week</time_frame>
    <description>Wound healing was evaluated with healing index.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>VAS scores for pain evaluation</measure>
    <time_frame>after surgery first seven days</time_frame>
    <description>Visual analog scale(VAS) with 100 mm was used in patient postoperative pain level for first seven days.No pain level was indicated as 0, and unbearable pain level on the VAS was also indicates as 100.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Plaque index</measure>
    <time_frame>change from baseline at following surgery first, third and sixth month respectively</time_frame>
    <description>plaque index (Silness &amp;Löe index) were recorded related to tooth's mean of mesial, distal, and the mid-facial surface measurements.</description>
  </other_outcome>
  <other_outcome>
    <measure>Gingival index</measure>
    <time_frame>change from baseline at following surgery first, third and sixth month respectively</time_frame>
    <description>Gingival index(Löe &amp;Silness index) were recorded related to tooth's mean of mesial, distal, and the mid-facial surface measurements.</description>
  </other_outcome>
  <other_outcome>
    <measure>Probing pocket depth</measure>
    <time_frame>change from baseline at following surgery first, third and sixth month respectively</time_frame>
    <description>Probing pocket depth was measured distance from the gingival margin to the bottom of the gingival crevice.</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">19</enrollment>
  <condition>Gingival Recession</condition>
  <arm_group>
    <arm_group_label>test groups</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In this split mouth study, bilaterally gingival recession defects were randomly treated in test(CGF+CAF) or control(SCTG+CAF) groups.In test groups, a special centrifuge machine(Medifuge) and subjects venous blood were used to obtain Concentrated growth factor. A special compress was used to transform Concentrated growth factor membrane.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control groups</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In this split mouth study, bilaterally gingival recession defects were randomly treated in test(CGF+CAF) or control(SCTG+CAF) groups. In control groups, subepithelial connective tissue graft was taken from the palatal canine teeth-first molar teeth area with a trap door technique according to the width of the exposed root surface and the adjacent bone margins. The graft's thickness was adjusted between 1.5 and 2 mm.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>test groups</intervention_name>
    <description>Coronally advanced flap procedure is a mucogingival surgery technique that was used to prepare recipient sites. Concentrated growth factor(CGF) membranes were placed over the exposed root surface. The flap was advanced 1 mm coronally from CEJ to completely cover.</description>
    <arm_group_label>test groups</arm_group_label>
    <other_name>CGF+ CAF groups</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>control groups</intervention_name>
    <description>Coronally advanced flap procedure is a mucogingival surgery technique that was used to prepare recipient sites. Subepithelial connective tissue graft was placed over the exposed root surface. The flap was advanced 1 mm coronally from CEJ to completely cover.</description>
    <arm_group_label>control groups</arm_group_label>
    <other_name>SCTG+CAF</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  age≥18&#xD;
&#xD;
          -  systemically and periodontally healthy non-smoker patients&#xD;
&#xD;
          -  multiple, adjacent, bilaterally Miller class I&#xD;
&#xD;
          -  recession depth ≥2 and ≤5 mm, probing depth≤3 mm, located lateral, canine or premolars&#xD;
             on same arch(maxilla or mandibula)&#xD;
&#xD;
          -  identifiable cemento-enamel junction&#xD;
&#xD;
          -  absence caries or restoration on buccal surface, endodontic treatment or problem&#xD;
&#xD;
          -  palatal donor tissue thickness ≥3 mm for SCTG&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  patients have smoking habit or systemic diseases that might be contraindication for&#xD;
             periodontal surgery&#xD;
&#xD;
          -  the presence of using medication affect that blood clotting mechanism and wound&#xD;
             healing&#xD;
&#xD;
          -  previous periodontal surgeries in gingival recession areas&#xD;
&#xD;
          -  pregnancy, lactation,or oral contraceptive drug intake for female patients&#xD;
&#xD;
          -  insufficient oral hygiene (full- mouth plaque and bleeding scores ≥15% after phase I&#xD;
             periodontal treatment)&#xD;
&#xD;
          -  unchanged traumatic tooth-brushing habit&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Fatma Berrin Ünsal</last_name>
    <role>Study Director</role>
    <affiliation>affiliated</affiliation>
  </overall_official>
  <results_reference>
    <citation>Bozkurt Dogan S, Ongoz Dede F, Balli U, Atalay EN, Durmuslar MC. Concentrated growth factor in the treatment of adjacent multiple gingival recessions: a split-mouth randomized clinical trial. J Clin Periodontol. 2015 Sep;42(9):868-875. doi: 10.1111/jcpe.12444. Epub 2015 Sep 22.</citation>
    <PMID>26269089</PMID>
  </results_reference>
  <results_reference>
    <citation>Tunaliota M, Ozdemir H, Arabaciota T, Gurbuzer B, Pikdoken L, Firatli E. Clinical evaluation of autologous platelet-rich fibrin in the treatment of multiple adjacent gingival recession defects: a 12-month study. Int J Periodontics Restorative Dent. 2015 Jan-Feb;35(1):105-14. doi: 10.11607/prd.1826.</citation>
    <PMID>25734713</PMID>
  </results_reference>
  <results_reference>
    <citation>Eren G, Atilla G. Platelet-rich fibrin in the treatment of localized gingival recessions: a split-mouth randomized clinical trial. Clin Oral Investig. 2014 Nov;18(8):1941-8. doi: 10.1007/s00784-013-1170-5. Epub 2013 Dec 22.</citation>
    <PMID>24362634</PMID>
  </results_reference>
  <results_reference>
    <citation>Jankovic S, Aleksic Z, Klokkevold P, Lekovic V, Dimitrijevic B, Kenney EB, Camargo P. Use of platelet-rich fibrin membrane following treatment of gingival recession: a randomized clinical trial. Int J Periodontics Restorative Dent. 2012 Apr;32(2):e41-50.</citation>
    <PMID>22292152</PMID>
  </results_reference>
  <results_reference>
    <citation>Jankovic S, Aleksic Z, Milinkovic I, Dimitrijevic B. The coronally advanced flap in combination with platelet-rich fibrin (PRF) and enamel matrix derivative in the treatment of gingival recession: a comparative study. Eur J Esthet Dent. 2010 Autumn;5(3):260-73.</citation>
    <PMID>20820456</PMID>
  </results_reference>
  <results_reference>
    <citation>Aroca S, Keglevich T, Barbieri B, Gera I, Etienne D. Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study. J Periodontol. 2009 Feb;80(2):244-52. doi: 10.1902/jop.2009.080253.</citation>
    <PMID>19186964</PMID>
  </results_reference>
  <results_reference>
    <citation>Del Corso M, Sammartino G, Dohan Ehrenfest DM. Re: &quot;Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study&quot;. J Periodontol. 2009 Nov;80(11):1694-7; author reply 1697-9. doi: 10.1902/jop.2009.090253.</citation>
    <PMID>19905939</PMID>
  </results_reference>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>December 30, 2016</study_first_submitted>
  <study_first_submitted_qc>January 12, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 13, 2017</study_first_posted>
  <last_update_submitted>February 7, 2019</last_update_submitted>
  <last_update_submitted_qc>February 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">February 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Gazi University</investigator_affiliation>
    <investigator_full_name>serap karakış akcan</investigator_full_name>
    <investigator_title>phd doctor</investigator_title>
  </responsible_party>
  <keyword>growth factor</keyword>
  <keyword>mucogingival surgery</keyword>
  <keyword>gingival recession</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>
    <ipd_description>there is no plan to make IPD. IPD will be formed if necessary.</ipd_description>
  </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/NCT03020732
org study id: 03/2011-16
nct id: NCT03020732
lead sponsor: 
has dmc: No
Platelet concentrates(PC) are used in the field of periodontology and implantology for the
      content necessary key cells and growth factors to accelerate healing and to provide
      regeneration. Concentrated Growth Factors(CGF) is defined as an innovative method or a new
      generation PC. The purpose of this clinical study was to evaluate the clinical effectiveness
      of Concentrated Growth Factor(CGF) membrane with coronally advanced flap(CAF) procedure's and
      subepithelial connective tissue graft(SCTG) with CAF in the treatment of Miller class I
      gingival recessions (GR).
CGF is defined as an innovative method to produce platelet rich fibrin(PRF) or a new
      generation platelet concentrate(PC).The rotational speed of the centrifuge machine used in
      CGF, varies between 2400-3000 rpm. The variability of the rotation speed during
      centrifugation allows a fibrin matrix that larger, more intensive and includes more growth
      factors than PRF. Some studies have been reported that CGF have an inducing effect on
      periodontal ligament stem cells for osteogenic differentiation and clinically provides new
      bone formation for the sinus augmentation. In literature, there is only one clinical research
      associated with multiple gingival recession defects treatment. It showed that CGF with CAF
      surgery increases keratinized gingiva weight and thickness and it maybe prevents
      post-operative relapse for CAF.

      PC has also been mentioned to be effective in to increase the width of keratinized tissue
      with providing root coverage and it may reduce early post-surgical complications, and
      accelerate wound healing in systematic review. In the treatment of isolated or multiple
      gingival recession, PRF and SCTG with CAF procedures have been reported to similar root
      coverage. PRF can be used as an alternative method for SCTG .CGF and PRF have similar
      composition. However higher resistance and viscosity of CGF may protect growth factors from
      proteolysis better than PRF. There is any comparative study for CGF and SCTG in literature in
      terms of clinically or patient related parameters.

      Therefore, the purpose of this clinical study is to evaluate the clinical efficacy of CGF in
      combination with CAF in the treatment of gingival recession's defects, and to compare SCTG in
      combination with CAF. It is also aimed to asses and compare postoperative pain and soft
      tissue healing.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: recession depth
time frame: change from baseline at following surgery first, third and sixth month respectively
description: recession depth was measured distance from cemento-enamel junction(CEJ) to the gingival margin, using periodontal probe at the mid-facial surface and rounded to the nearest millimeters.
measure: root coverage
time frame: change from baseline at following surgery first, third and sixth month respectively
description: Root coverage(RC) was calculated for multiple recession defects groups with a formula.
measure: keratinized tissue thickness
time frame: change from baseline at following surgery first, third and sixth month respectively
description: Keratinized tissue thickness(KTT) value was obtained from a digital caliper with the accuracy of 0.01 mm and using a 15 endodontic reamer, on mid-point localization of keratinized tissue or the alveolar mucosa, at level bottom of the gingival crevice.
measure: keratinized tissue weight
time frame: change from baseline at following surgery first, third and sixth month respectively
description: keratinized tissue weight was measured distance from the free gingival margin to the mucogingival junction, using periodontal probe at the mid-facial surface and rounded to the nearest millimeters.
measure: clinical attachment level
time frame: change from baseline at following surgery first, third and sixth month respectively
description: clinical attachment level was mesured distance from CEJ to the bottom of the gingival crevice
measure: wound healing
time frame: after surgery first, second and third week
description: Wound healing was evaluated with healing index.
measure: VAS scores for pain evaluation
time frame: after surgery first seven days
description: Visual analog scale(VAS) with 100 mm was used in patient postoperative pain level for first seven days.No pain level was indicated as 0, and unbearable pain level on the VAS was also indicates as 100.
measure: Plaque index
time frame: change from baseline at following surgery first, third and sixth month respectively
description: plaque index (Silness &Löe index) were recorded related to tooth's mean of mesial, distal, and the mid-facial surface measurements.
measure: Gingival index
time frame: change from baseline at following surgery first, third and sixth month respectively
description: Gingival index(Löe &Silness index) were recorded related to tooth's mean of mesial, distal, and the mid-facial surface measurements.
measure: Probing pocket depth
time frame: change from baseline at following surgery first, third and sixth month respectively
description: Probing pocket depth was measured distance from the gingival margin to the bottom of the gingival crevice.
arm group label: test groups
arm group type: Experimental
description: In this split mouth study, bilaterally gingival recession defects were randomly treated in test(CGF+CAF) or control(SCTG+CAF) groups.In test groups, a special centrifuge machine(Medifuge) and subjects venous blood were used to obtain Concentrated growth factor. A special compress was used to transform Concentrated growth factor membrane.
arm group label: control groups
arm group type: Active Comparator
description: In this split mouth study, bilaterally gingival recession defects were randomly treated in test(CGF+CAF) or control(SCTG+CAF) groups. In control groups, subepithelial connective tissue graft was taken from the palatal canine teeth-first molar teeth area with a trap door technique according to the width of the exposed root surface and the adjacent bone margins. The graft's thickness was adjusted between 1.5 and 2 mm.
intervention type: Procedure
intervention name: test groups
description: Coronally advanced flap procedure is a mucogingival surgery technique that was used to prepare recipient sites. Concentrated growth factor(CGF) membranes were placed over the exposed root surface. The flap was advanced 1 mm coronally from CEJ to completely cover.
arm group label: test groups
other name: CGF+ CAF groups
intervention type: Procedure
intervention name: control groups
description: Coronally advanced flap procedure is a mucogingival surgery technique that was used to prepare recipient sites. Subepithelial connective tissue graft was placed over the exposed root surface. The flap was advanced 1 mm coronally from CEJ to completely cover.
arm group label: control groups
other name: SCTG+CAF
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Fatma Berrin Ünsal
role: Study Director
affiliation: affiliated
citation: Bozkurt Dogan S, Ongoz Dede F, Balli U, Atalay EN, Durmuslar MC. Concentrated growth factor in the treatment of adjacent multiple gingival recessions: a split-mouth randomized clinical trial. J Clin Periodontol. 2015 Sep;42(9):868-875. doi: 10.1111/jcpe.12444. Epub 2015 Sep 22.
PMID: 26269089
citation: Tunaliota M, Ozdemir H, Arabaciota T, Gurbuzer B, Pikdoken L, Firatli E. Clinical evaluation of autologous platelet-rich fibrin in the treatment of multiple adjacent gingival recession defects: a 12-month study. Int J Periodontics Restorative Dent. 2015 Jan-Feb;35(1):105-14. doi: 10.11607/prd.1826.
PMID: 25734713
citation: Eren G, Atilla G. Platelet-rich fibrin in the treatment of localized gingival recessions: a split-mouth randomized clinical trial. Clin Oral Investig. 2014 Nov;18(8):1941-8. doi: 10.1007/s00784-013-1170-5. Epub 2013 Dec 22.
PMID: 24362634
citation: Jankovic S, Aleksic Z, Klokkevold P, Lekovic V, Dimitrijevic B, Kenney EB, Camargo P. Use of platelet-rich fibrin membrane following treatment of gingival recession: a randomized clinical trial. Int J Periodontics Restorative Dent. 2012 Apr;32(2):e41-50.
PMID: 22292152
citation: Jankovic S, Aleksic Z, Milinkovic I, Dimitrijevic B. The coronally advanced flap in combination with platelet-rich fibrin (PRF) and enamel matrix derivative in the treatment of gingival recession: a comparative study. Eur J Esthet Dent. 2010 Autumn;5(3):260-73.
PMID: 20820456
citation: Aroca S, Keglevich T, Barbieri B, Gera I, Etienne D. Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study. J Periodontol. 2009 Feb;80(2):244-52. doi: 10.1902/jop.2009.080253.
PMID: 19186964
citation: Del Corso M, Sammartino G, Dohan Ehrenfest DM. Re: "Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study". J Periodontol. 2009 Nov;80(11):1694-7; author reply 1697-9. doi: 10.1902/jop.2009.090253.
PMID: 19905939
responsible party type: Principal Investigator
investigator affiliation: Gazi University
investigator full name: serap karakış akcan
investigator title: phd doctor
mesh term: Gingival Recession
sharing ipd: Undecided
ipd description: there is no plan to make IPD. IPD will be formed if necessary.