<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/NCT04507009</url>
  </required_header>
  <id_info>
    <org_study_id>A-2005</org_study_id>
    <nct_id>NCT04507009</nct_id>
  </id_info>
  <brief_title>Clinical Investigation of the Efficacy of CGF and Ozone in the Treatment of Alveolar Osteitis</brief_title>
  <official_title>Clinical Investigation of the Efficacy of CGF (Concentrated Growth Factor) and Ozone in the Treatment of Alveolar Osteitis</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>T.C. ORDU ÜNİVERSİTESİ</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>T.C. ORDU ÜNİVERSİTESİ</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>
      The aim of this study is to investigate the efficacy of CGF and Ozone in the treatment of&#xD;
      alveolitis and to develop a new treatment protocol that can enable a quick and effective&#xD;
      solution of this clinical problem, which significantly affects patients' comfort of life.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      In the present study, 60 healthy patients &gt; 18 years old and have alveolitis, will included.&#xD;
      60 patient will divided randomly into three groups as Control, Ozone and Ozone+CGF. After&#xD;
      irrigation of the sockets alvogyl, ozone and ozone+CGF will applied to the sockets&#xD;
      respectively. Post operative pain, will measured at 1st to 7th days. Post operative&#xD;
      infection, and granulation tissue will measured at 1st, 3rd and 7th days. Oral hygiene will&#xD;
      evaluated at first visit. Quality of life will evaluated at 7th day.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">August 1, 2020</start_date>
  <completion_date type="Actual">October 1, 2022</completion_date>
  <primary_completion_date type="Actual">August 1, 2022</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 (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in post-operative pain assessed: visual analog (VAS) scale</measure>
    <time_frame>6th and 24th hour, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day</time_frame>
    <description>For the evaluation of the pain, the visual analog scale (VAS) will be used to express the absence of pain in the initial part on a straight line (0) and the end part to express the unbearable pain (10).&#xD;
0 (no pain)--------------------------------------------------------------------------------10 (unbearable pain) Higher values of the scale represent worse outcome.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Granulation tissue health</measure>
    <time_frame>postoperative 1st, 3rd, 7th days</time_frame>
    <description>Granulation tissue formation in the area after treatment will be evaluated clinically. Granulation tissue will be scored as healthy (pink color and no bleeding on probing) and unhealthy granulation tissue (dark red in color and usually bleeding on probing).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Inflamation severity</measure>
    <time_frame>postoperative 1st, 3rd, 7th days</time_frame>
    <description>The severity of inflammation will be assessed using the gingival index; From values 0 to 3; 0.Normal gingiva&#xD;
Slight inflammation-slight discoloration, mild edema. no probing on bleeding,&#xD;
Moderate inflammation - redness, edema. bleeding on probing,&#xD;
Severe inflammation-marked redness and edema, ulceration and tendency to spontaneous bleeding</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change in the quality of postoperative life after the procedures performed</measure>
    <time_frame>postoperative 7th day</time_frame>
    <description>The evaluation of the change in postoperative quality of life will be done with a scale of post-operative symptom severity (PoSSe) consisting of 15-item questionnaire in which the effect of operation on eating, speech, sensation, appearance, pain, disease and daily activities is evaluated. This questionnaire was divided into subscales corresponding to seven main adverse effects, and for each possible answer there was a score ranging from 0 to a variable number. For total possible answer there was a score ranging from 0 to a 97.9. Higher values of the scale represent worse outcome.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Oral hygiene degree</measure>
    <time_frame>Evaluation of the oral hygiene before operation</time_frame>
    <description>Oral hygiene of the patient will be evaluated in 3 groups as poor, moderate and good.&#xD;
Good&#xD;
Patients with a low incidence of active caries,&#xD;
Patients with no bleeding and non-inflamed gums, as well as no plaque, calculus, and gingival pocket formation.&#xD;
Bad&#xD;
Patients with periodontitis, inflamed gums, bleeding on probing, pocket formation,calculus&#xD;
Patients with active caries.&#xD;
Moderate&#xD;
Patients other than these two groups will be evaluated as moderate.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">60</enrollment>
  <condition>Alveolar Osteitis</condition>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Traditional treatment group which alvogyl applied to the socket after irrigation</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Ozone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Ozone group which Ozone (O3) applied after irrigation of the socket</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CGF +Ozone</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>CGF + Ozone group which concentrated growth factor (CGF) after Ozone (O3) applied followed by irrigation of the socket.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Ozone</intervention_name>
    <description>topical gaseous ozone application</description>
    <arm_group_label>CGF +Ozone</arm_group_label>
    <arm_group_label>Ozone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>CGF</intervention_name>
    <description>concentrated growth factor (CGF) application</description>
    <arm_group_label>CGF +Ozone</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Traditional treatment</intervention_name>
    <description>Alvogyl application</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Patients who have one or more of the following in addition to severe pain, which occur&#xD;
        within and around the socket 1-3 days after extraction and do not decrease with pain&#xD;
        killers;&#xD;
&#xD;
          -  With a partially or completely disintegrated blood clot in the socket&#xD;
&#xD;
          -  With exposed bone that gives a dark gray appearance&#xD;
&#xD;
          -  With bad odor&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Who does not want to be volunteer for the study,&#xD;
&#xD;
          -  Smokers,&#xD;
&#xD;
          -  During pregnancy or lactation,&#xD;
&#xD;
          -  Has a chronic systemic disorder that will affect recovery,&#xD;
&#xD;
          -  Has hematological disorder&#xD;
&#xD;
          -  Cooperation cannot be established,&#xD;
&#xD;
          -  Previously received radiotherapy or chemotherapy,&#xD;
&#xD;
          -  Patients using oral contraceptives&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>90 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Damla Torul, DDS PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>T.C. ORDU ÜNİVERSİTESİ</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Ordu University</name>
      <address>
        <city>Ordu</city>
        <zip>52200</zip>
        <country>Turkey</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <verification_date>November 2022</verification_date>
  <study_first_submitted>August 4, 2020</study_first_submitted>
  <study_first_submitted_qc>August 5, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">August 10, 2020</study_first_posted>
  <last_update_submitted>November 5, 2022</last_update_submitted>
  <last_update_submitted_qc>November 5, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">November 9, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>T.C. ORDU ÜNİVERSİTESİ</investigator_affiliation>
    <investigator_full_name>Dr. Damla Torul</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>Alveolitis</keyword>
  <keyword>Dry socket</keyword>
  <keyword>Ozone</keyword>
  <keyword>CGF</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Osteitis</mesh_term>
    <mesh_term>Dry Socket</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>IPD can share with other researchers on demand</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/NCT04507009
org study id: A-2005
nct id: NCT04507009
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
The aim of this study is to investigate the efficacy of CGF and Ozone in the treatment of
      alveolitis and to develop a new treatment protocol that can enable a quick and effective
      solution of this clinical problem, which significantly affects patients' comfort of life.
In the present study, 60 healthy patients > 18 years old and have alveolitis, will included.
      60 patient will divided randomly into three groups as Control, Ozone and Ozone+CGF. After
      irrigation of the sockets alvogyl, ozone and ozone+CGF will applied to the sockets
      respectively. Post operative pain, will measured at 1st to 7th days. Post operative
      infection, and granulation tissue will measured at 1st, 3rd and 7th days. Oral hygiene will
      evaluated at first visit. Quality of life will evaluated at 7th day.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Change in post-operative pain assessed: visual analog (VAS) scale
time frame: 6th and 24th hour, 2nd day, 3rd day, 4th day, 5th day, 6th day and 7th day
description: For the evaluation of the pain, the visual analog scale (VAS) will be used to express the absence of pain in the initial part on a straight line (0) and the end part to express the unbearable pain (10).
0 (no pain)--------------------------------------------------------------------------------10 (unbearable pain) Higher values of the scale represent worse outcome.
measure: Granulation tissue health
time frame: postoperative 1st, 3rd, 7th days
description: Granulation tissue formation in the area after treatment will be evaluated clinically. Granulation tissue will be scored as healthy (pink color and no bleeding on probing) and unhealthy granulation tissue (dark red in color and usually bleeding on probing).
measure: Inflamation severity
time frame: postoperative 1st, 3rd, 7th days
description: The severity of inflammation will be assessed using the gingival index; From values 0 to 3; 0.Normal gingiva
Slight inflammation-slight discoloration, mild edema. no probing on bleeding,
Moderate inflammation - redness, edema. bleeding on probing,
Severe inflammation-marked redness and edema, ulceration and tendency to spontaneous bleeding
measure: Change in the quality of postoperative life after the procedures performed
time frame: postoperative 7th day
description: The evaluation of the change in postoperative quality of life will be done with a scale of post-operative symptom severity (PoSSe) consisting of 15-item questionnaire in which the effect of operation on eating, speech, sensation, appearance, pain, disease and daily activities is evaluated. This questionnaire was divided into subscales corresponding to seven main adverse effects, and for each possible answer there was a score ranging from 0 to a variable number. For total possible answer there was a score ranging from 0 to a 97.9. Higher values of the scale represent worse outcome.
measure: Oral hygiene degree
time frame: Evaluation of the oral hygiene before operation
description: Oral hygiene of the patient will be evaluated in 3 groups as poor, moderate and good.
Good
Patients with a low incidence of active caries,
Patients with no bleeding and non-inflamed gums, as well as no plaque, calculus, and gingival pocket formation.
Bad
Patients with periodontitis, inflamed gums, bleeding on probing, pocket formation,calculus
Patients with active caries.
Moderate
Patients other than these two groups will be evaluated as moderate.
arm group label: Control
arm group type: Active Comparator
description: Traditional treatment group which alvogyl applied to the socket after irrigation
arm group label: Ozone
arm group type: Experimental
description: Ozone group which Ozone (O3) applied after irrigation of the socket
arm group label: CGF +Ozone
arm group type: Experimental
description: CGF + Ozone group which concentrated growth factor (CGF) after Ozone (O3) applied followed by irrigation of the socket.
intervention type: Device
intervention name: Ozone
description: topical gaseous ozone application
arm group label: CGF +Ozone
arm group label: Ozone
intervention type: Other
intervention name: CGF
description: concentrated growth factor (CGF) application
arm group label: CGF +Ozone
intervention type: Other
intervention name: Traditional treatment
description: Alvogyl application
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: 90 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Damla Torul, DDS PhD
role: Principal Investigator
affiliation: T.C. ORDU ÜNİVERSİTESİ
facility: 
country: Turkey
responsible party type: Principal Investigator
investigator affiliation: T.C. ORDU ÜNİVERSİTESİ
investigator full name: Dr. Damla Torul
investigator title: Associate Professor
mesh term: Osteitis
mesh term: Dry Socket
sharing ipd: No
ipd description: IPD can share with other researchers on demand