<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/NCT03819244</url>
  </required_header>
  <id_info>
    <org_study_id>24112017-01</org_study_id>
    <nct_id>NCT03819244</nct_id>
  </id_info>
  <brief_title>Comparison of Er,Cr:YSGG and Diode Lasers In Second Stage Implant Surgery</brief_title>
  <official_title>Clinical Comparison of The Use of Er,Cr:YSGG and Diode Lasers In Second Stage Implant Surgery</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>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>Yes</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The study evaluates postoperative pain, intraoperative bleeding and wound healing after&#xD;
      second stage implant surgery. Submerged implants were exposed with diode laser in Group 1&#xD;
      (n=20) and by using Er,Cr:YSGG laser in Group 2 (n=20).&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 27, 2017</start_date>
  <completion_date type="Actual">August 20, 2018</completion_date>
  <primary_completion_date type="Actual">May 24, 2018</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>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Postoperative pain on 1st day</measure>
    <time_frame>1st Day</time_frame>
    <description>Patients score pain intensity with numeric scale ranging between 0(no pain) to 10(most severe pain) on the postoperative 1st day. Pain scores on the postoperative 1st day in each group are compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain on 2nd day</measure>
    <time_frame>2nd Day</time_frame>
    <description>Patients score pain intensity with numeric scale ranging between 0(no pain) to 10(most severe pain) on the postoperative 2nd day. Pain scores on the postoperative 2nd day in each group are compared.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Postoperative pain on 3rd day</measure>
    <time_frame>3rd Day</time_frame>
    <description>Patients score pain intensity with numeric scale ranging between 0(no pain) to 10(most severe pain) on the postoperative 3rd day. Pain scores on the postoperative 3rd day in each group are compared.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Number of analgesics used daily</measure>
    <time_frame>3 days</time_frame>
    <description>Analgesic consumption per day on postoperative 1st, 2nd and 3rd days.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Intraoperative bleeding</measure>
    <time_frame>During operation</time_frame>
    <description>Bleeding during surgical procedure was scored by the physician as 1=minimal, 2=normal and 3=excessive bleeding</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">40</enrollment>
  <condition>Postoperative Pain</condition>
  <condition>Soft Tissue Bleeding</condition>
  <condition>Wound Heal</condition>
  <arm_group>
    <arm_group_label>Diode laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Soft tissue incision with 940 nm Gallium Aluminum Arsenide diode laser, at implant recovery settings (2.5 W output power, average power: 1.25 W, pulse length : 1.00 ms, pulse interval: 1.00 ms) in second-stage implant surgery.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Erbium laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Soft tissue incision with 2780 nm Er,Cr:YSGG laser, at implant recovery settings (2.00 W power, 100 Hz, H mode, 10% water and 10% air) in second-stage implant surgery.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>940 nm Gallium Aluminum Arsenide Diode Laser</intervention_name>
    <description>Exposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with diode laser for placing the healing abutment.</description>
    <arm_group_label>Diode laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>2780 nm Er,Cr:YSGG Laser</intervention_name>
    <description>Exposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with erbium laser for placing the healing abutment.</description>
    <arm_group_label>Erbium laser</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  subject has osseointegrated implants embedded under oral mucosa.&#xD;
&#xD;
          -  subject undergoes second-stage implant surgery.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  inadequate keratinized gingiva in the implant site.&#xD;
&#xD;
          -  localization of the implant site is not possible due to excessive thickness of the&#xD;
             oral mucosa&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Erkan Feslihan, DDS</last_name>
    <role>Principal Investigator</role>
    <affiliation>Van Yuzuncu Yil University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Yuzuncu Yil University Faculty of Dentistry</name>
      <address>
        <city>Van</city>
        <zip>65080</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>El-Kholey KE. Efficacy and safety of a diode laser in second-stage implant surgery: a comparative study. Int J Oral Maxillofac Surg. 2014 May;43(5):633-8. doi: 10.1016/j.ijom.2013.10.003. Epub 2013 Nov 7.</citation>
    <PMID>24210453</PMID>
  </reference>
  <reference>
    <citation>Arnabat-Dominguez J, Espana-Tost AJ, Berini-Aytes L, Gay-Escoda C. Erbium:YAG laser application in the second phase of implant surgery: a pilot study in 20 patients. Int J Oral Maxillofac Implants. 2003 Jan-Feb;18(1):104-12.</citation>
    <PMID>12608675</PMID>
  </reference>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 16, 2019</study_first_submitted>
  <study_first_submitted_qc>January 24, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>January 25, 2019</last_update_submitted>
  <last_update_submitted_qc>January 25, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 29, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Yuzuncu Yıl University</investigator_affiliation>
    <investigator_full_name>Erkan Feslihan</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Diode Laser</keyword>
  <keyword>Erbium Laser</keyword>
  <keyword>Second-stage Implant Surgery</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>Individual participant data will be shared after publication of the article about this study.</ipd_description>
    <ipd_info_type>Study Protocol</ipd_info_type>
    <ipd_time_frame>Data will be available within 6 months.</ipd_time_frame>
    <ipd_access_criteria>Open access</ipd_access_criteria>
  </patient_data>
  <provided_document_section>
    <provided_document>
      <document_type>Study Protocol and Statistical Analysis Plan</document_type>
      <document_has_protocol>Yes</document_has_protocol>
      <document_has_icf>No</document_has_icf>
      <document_has_sap>Yes</document_has_sap>
      <document_date>November 24, 2017</document_date>
      <document_url>https://ClinicalTrials.gov/ProvidedDocs/44/NCT03819244/Prot_SAP_000.pdf</document_url>
    </provided_document>
  </provided_document_section>
  <!-- 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/NCT03819244
org study id: 24112017-01
nct id: NCT03819244
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: Yes
The study evaluates postoperative pain, intraoperative bleeding and wound healing after
      second stage implant surgery. Submerged implants were exposed with diode laser in Group 1
      (n=20) and by using Er,Cr:YSGG laser in Group 2 (n=20).
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: Postoperative pain on 1st day
time frame: 1st Day
description: Patients score pain intensity with numeric scale ranging between 0(no pain) to 10(most severe pain) on the postoperative 1st day. Pain scores on the postoperative 1st day in each group are compared.
measure: Postoperative pain on 2nd day
time frame: 2nd Day
description: Patients score pain intensity with numeric scale ranging between 0(no pain) to 10(most severe pain) on the postoperative 2nd day. Pain scores on the postoperative 2nd day in each group are compared.
measure: Postoperative pain on 3rd day
time frame: 3rd Day
description: Patients score pain intensity with numeric scale ranging between 0(no pain) to 10(most severe pain) on the postoperative 3rd day. Pain scores on the postoperative 3rd day in each group are compared.
measure: Number of analgesics used daily
time frame: 3 days
description: Analgesic consumption per day on postoperative 1st, 2nd and 3rd days.
measure: Intraoperative bleeding
time frame: During operation
description: Bleeding during surgical procedure was scored by the physician as 1=minimal, 2=normal and 3=excessive bleeding
arm group label: Diode laser
arm group type: Experimental
description: Soft tissue incision with 940 nm Gallium Aluminum Arsenide diode laser, at implant recovery settings (2.5 W output power, average power: 1.25 W, pulse length : 1.00 ms, pulse interval: 1.00 ms) in second-stage implant surgery.
arm group label: Erbium laser
arm group type: Experimental
description: Soft tissue incision with 2780 nm Er,Cr:YSGG laser, at implant recovery settings (2.00 W power, 100 Hz, H mode, 10% water and 10% air) in second-stage implant surgery.
intervention type: Device
intervention name: 940 nm Gallium Aluminum Arsenide Diode Laser
description: Exposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with diode laser for placing the healing abutment.
arm group label: Diode laser
intervention type: Device
intervention name: 2780 nm Er,Cr:YSGG Laser
description: Exposure of the cover screw of osseointegrated dental implants embedded under oral mucosa by performing the soft tissue incision with erbium laser for placing the healing abutment.
arm group label: Erbium laser
criteria: 
gender: All
minimum age: 18 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Erkan Feslihan, DDS
role: Principal Investigator
affiliation: Van Yuzuncu Yil University
facility: 
country: Turkey
citation: El-Kholey KE. Efficacy and safety of a diode laser in second-stage implant surgery: a comparative study. Int J Oral Maxillofac Surg. 2014 May;43(5):633-8. doi: 10.1016/j.ijom.2013.10.003. Epub 2013 Nov 7.
PMID: 24210453
citation: Arnabat-Dominguez J, Espana-Tost AJ, Berini-Aytes L, Gay-Escoda C. Erbium:YAG laser application in the second phase of implant surgery: a pilot study in 20 patients. Int J Oral Maxillofac Implants. 2003 Jan-Feb;18(1):104-12.
PMID: 12608675
responsible party type: Principal Investigator
investigator affiliation: Yuzuncu Yıl University
investigator full name: Erkan Feslihan
investigator title: Principal investigator
mesh term: Pain, Postoperative
sharing ipd: Yes
ipd description: Individual participant data will be shared after publication of the article about this study.
ipd info type: Study Protocol
ipd time frame: Data will be available within 6 months.
ipd access criteria: Open access
provided document: 