<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/NCT03031756</url>
  </required_header>
  <id_info>
    <org_study_id>33-236-2015</org_study_id>
    <nct_id>NCT03031756</nct_id>
  </id_info>
  <brief_title>Efficacy of Glycine Powder Air-Polishing Combined With Scaling and Root Planing in the Treatment of Periodontitis and Halitosis</brief_title>
  <official_title>Efficacy of Glycine Powder Air-Polishing Combined With Scaling and Root Planing in the Treatment of Periodontitis and Halitosis: A Randomized Clinical Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Near East University, Turkey</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Near East University, Turkey</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this clinical study was to evaluate the clinical efficacy of using perio flow&#xD;
      adjunctively with mechanical instrumentation on periodontal parameters and halitosis.&#xD;
&#xD;
      Sixty patients who presented with 4-6-mm probing pocket depth (PPD) were recruited for the&#xD;
      study. Patients were randomly assigned to glycine powder air-polishing (GPAP) or control&#xD;
      groups. For both groups PPDscores were recorded at the baseline and 1 month. Volatile sulphur&#xD;
      compound (VSC) values were measured by a halimeter at the baseline, immediately after&#xD;
      treatment, and at 7 days, 14 days and 1 month.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>January 2015</start_date>
  <completion_date type="Actual">April 2016</completion_date>
  <primary_completion_date type="Actual">July 2015</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>Supportive Care</primary_purpose>
    <masking>Single (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Periodontal Pocket Depth (PPD)</measure>
    <time_frame>30 day.</time_frame>
    <description>PD were evaluated:at the follow-up sessions by the investigator with by marking a point on a 10 mm periodontal probe.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>halimeter values.</measure>
    <time_frame>30 day.</time_frame>
    <description>The changes of Volatile Sulphure Compaunds by were evaluated with Halimeter Device at the follow-up sessions by the investigator. The Halimeter reads out in parts-per-billion (ppb) of volatile sulfur compounds.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Halitosis</condition>
  <arm_group>
    <arm_group_label>test</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>SRP was performed using routine ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland) and hand instrumentation, glycine powder air-polishing (GPAP) was performed for 10 seconds per surface after the instrumentation (Air-Flows Perio Powder, EMS, Nyon, Switzerland) was applied using a Perio-Flows hand-piece connected to an airflow unit (Air-Flow Masters, EMS).</description>
  </arm_group>
  <arm_group>
    <arm_group_label>control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>In the control group, SRP was performed using routine ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland) and hand instrumentation.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>glycine powder air-polishing (Air-Flows)Perio Powder</intervention_name>
    <arm_group_label>test</arm_group_label>
    <other_name>EMS, Nyon</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland)</intervention_name>
    <arm_group_label>control</arm_group_label>
    <arm_group_label>test</arm_group_label>
    <other_name>EMS Piezon Master</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  In the present trial, patients who had at least three teeth with 4-6-mm periodontal&#xD;
             pockets.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  acute infectious oral lesions,&#xD;
&#xD;
          -  furcation defects,&#xD;
&#xD;
          -  using antibiotics for any reason in the last 4 weeks,&#xD;
&#xD;
          -  periodontal treatment in the last 6 months and&#xD;
&#xD;
          -  pregnant or lactating patients.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>28 Years</minimum_age>
    <maximum_age>68 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hasan Guney YILMAZ, DDS,PhD</last_name>
    <role>Study Director</role>
    <affiliation>Near East University, Faculty of Dentistry</affiliation>
  </overall_official>
  <verification_date>January 2017</verification_date>
  <study_first_submitted>January 16, 2017</study_first_submitted>
  <study_first_submitted_qc>January 25, 2017</study_first_submitted_qc>
  <study_first_posted type="Estimate">January 26, 2017</study_first_posted>
  <last_update_submitted>January 25, 2017</last_update_submitted>
  <last_update_submitted_qc>January 25, 2017</last_update_submitted_qc>
  <last_update_posted type="Estimate">January 26, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Near East University, Turkey</investigator_affiliation>
    <investigator_full_name>Hasan Guney YILMAZ</investigator_full_name>
    <investigator_title>Assoc Prof Dr</investigator_title>
  </responsible_party>
  <keyword>Air polishing</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
    <mesh_term>Halitosis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Glycine</mesh_term>
  </intervention_browse>
  <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/NCT03031756
org study id: 33-236-2015
nct id: NCT03031756
lead sponsor: 
has dmc: No
The aim of this clinical study was to evaluate the clinical efficacy of using perio flow
      adjunctively with mechanical instrumentation on periodontal parameters and halitosis.

      Sixty patients who presented with 4-6-mm probing pocket depth (PPD) were recruited for the
      study. Patients were randomly assigned to glycine powder air-polishing (GPAP) or control
      groups. For both groups PPDscores were recorded at the baseline and 1 month. Volatile sulphur
      compound (VSC) values were measured by a halimeter at the baseline, immediately after
      treatment, and at 7 days, 14 days and 1 month.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Supportive Care
masking: Single (Participant)
measure: Periodontal Pocket Depth (PPD)
time frame: 30 day.
description: PD were evaluated:at the follow-up sessions by the investigator with by marking a point on a 10 mm periodontal probe.
measure: halimeter values.
time frame: 30 day.
description: The changes of Volatile Sulphure Compaunds by were evaluated with Halimeter Device at the follow-up sessions by the investigator. The Halimeter reads out in parts-per-billion (ppb) of volatile sulfur compounds.
arm group label: test
arm group type: Experimental
description: SRP was performed using routine ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland) and hand instrumentation, glycine powder air-polishing (GPAP) was performed for 10 seconds per surface after the instrumentation (Air-Flows Perio Powder, EMS, Nyon, Switzerland) was applied using a Perio-Flows hand-piece connected to an airflow unit (Air-Flow Masters, EMS).
arm group label: control
arm group type: Active Comparator
description: In the control group, SRP was performed using routine ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland) and hand instrumentation.
intervention type: Device
intervention name: glycine powder air-polishing (Air-Flows)Perio Powder
arm group label: test
other name: EMS, Nyon
intervention type: Device
intervention name: ultrasonic (Piezon Master 700; EMS, Nyon, Switzerland)
arm group label: control
arm group label: test
other name: EMS Piezon Master
criteria: 
gender: All
minimum age: 28 Years
maximum age: 68 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hasan Guney YILMAZ, DDS,PhD
role: Study Director
affiliation: Near East University, Faculty of Dentistry
responsible party type: Principal Investigator
investigator affiliation: Near East University, Turkey
investigator full name: Hasan Guney YILMAZ
investigator title: Assoc Prof Dr
mesh term: Periodontitis
mesh term: Halitosis
mesh term: Glycine
sharing ipd: No