xml: <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/NCT05989750</url>
    </required_header>
    <id_info>
      <org_study_id>BASEC 2023-D0032</org_study_id>
      <nct_id>NCT05989750</nct_id>
    </id_info>
    <brief_title>Air-polishing With Erythritol During Orthodontic Tretament</brief_title>
    <acronym>AirPort</acronym>
    <official_title>Air-polishing With Erythritol on Prevalence of White Spot Lesions and Gingivitis During Orthodontic Treatment With Fixed Appliances: a Randomized Clinical Trial of 2-years Duration</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Catherine Giannopoulou</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University of Geneva, Switzerland</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Geneva, Switzerland</source>
    <oversight_info>
      <has_dmc>Yes</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>
        Patients with multi-bracketed fixed orthodontic treatment are at increased risk of developing&#xD;
        white spot lesions (WSL) and gingivitis. Various preventive strategies have been examined to&#xD;
        prevent the development of WSLs. During initial non-surgical periodontal therapy, the use of&#xD;
        subgingival air-polishing with erythritol powder has shown promising results in reducing deep&#xD;
        pockets and gingival inflammation. The efficacy of its use as monotherapy in preventing WSLs&#xD;
        and gingival inflammation in patients during orthodontic treatment, has not yet been tested.&#xD;
  &#xD;
        The primary objective of the present study is to compare the effectiveness of an&#xD;
        air-polishing device used as monotherapy versus ultrasonic instrumentation (the current gold&#xD;
        standard procedure) in preventing white spot lesions (WSL) and gingivitis among young&#xD;
        patients undergoing multi-bracketed fixed orthodontic treatment.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a randomized clinical study for evaluating the performance of an air-polishing device&#xD;
        in preventing WSLs and gingivitis among patients undergoing multi-bracketed fixed orthodontic&#xD;
        treatment. The null hypothesis tested is that there is no difference between the&#xD;
        air-polishing device and the conventional ultrasonic device in preventing WSLs and gingivitis&#xD;
        during orthodontic treatment.&#xD;
  &#xD;
        Clinical examination and clinical samples will be taken before, during and after orthodontic&#xD;
        treatment. It is a single center study of 3 years duration involving samples of 60 patients&#xD;
        attending the Division of Orthodontics for treatment. Half of the participants will be&#xD;
        randomly assigned for treatment with the air-polishing device in every orthodontic&#xD;
        appointment, meaning once per month, the other half will be treated with a standard&#xD;
        ultrasonic scaler every six months. The study duration for each participant will be&#xD;
        approximately 2 years. The investigators will then analyze the prevalence of WSLs using the&#xD;
        Quantitative light-induced fluorescence (QLF) method. Gingivitis will be evaluated throughout&#xD;
        the study by using standard clinical parameters; the antimicrobial efficacy against several&#xD;
        known periodontal pathogens and the host-response (inflammatory markers in GCF) will be&#xD;
        measured by the qPCR assay and the multiplex immunoassay, respectively. Clinical evaluation&#xD;
        and collection of samples for microbial and host response analysis will be performed every 6&#xD;
        months. Incidence of bracket debonding we will be calculated and compared.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 11, 2023</start_date>
    <completion_date type="Anticipated">September 2026</completion_date>
    <primary_completion_date type="Anticipated">September 11, 2025</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>
      <intervention_model_description>Randomized, examiner-masked clinical trial</intervention_model_description>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Investigator)</masking>
      <masking_description>The examiner, the biostatistician and people working in the laboratory for the analyses, will be blinded for allocation group. Only the operator and the participant will be aware of the type of treatment based on the computer-generated allocation table that will be kept at the Trial Master File (TMF) of the study.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Appearance of white spot lesions (WSL) during orthodontic movement with fixed appliances.</measure>
      <time_frame>2 years</time_frame>
      <description>the formation of white spot lesions during the 2-years period of orthodontic treatment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Appearance on inflammatory lesions during orthodontic treatmnet</measure>
      <time_frame>2 years</time_frame>
      <description>Signs of inflammation based on clinical parameters during the 2-year period of orthodontic treatment</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Changes from baseline in clinical parameters</measure>
      <time_frame>2 years</time_frame>
      <description>plaque accumulation gingival inflammation pocket probing depth bleeding on probing gingival recessions</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Patient acceptance</measure>
      <time_frame>2 years</time_frame>
      <description>Visual Analogue Scale (VAS) with 0: very satisfied and 10: unsatisfied</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Tooth sensitivity</measure>
      <time_frame>2 years</time_frame>
      <description>Visual Analogue Scale (VAS) with 0: no sensitivity and 10: worst senstitivity</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Total bacterial counts and counts of 6 periodontal pathogens in subgingival samples from treated pockets</measure>
      <time_frame>2 years</time_frame>
      <description>Changes from baseline of microorganisms will be identified and enumerated by laboratory Real-time Polymerase Chain Reaction</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Inflammatory markers in GCF from baseline</measure>
      <time_frame>2 years</time_frame>
      <description>Changes of the Inflammatory markers in the gingival crevicular fluid (GCF) throughout the study will be analyzed by the Bioplex 200 Suspension array system.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Toral tretament time</measure>
      <time_frame>2 years</time_frame>
      <description>Treatment time will be recorded at each visit</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">60</enrollment>
    <condition>Inflammation Gum</condition>
    <condition>White Spot Lesion</condition>
    <arm_group>
      <arm_group_label>Control procedure</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Ultrasonic scaling and polishing will be performed every 6 months for subgingival cleaning</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Test procedure</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>AIR-FLOW PROPHYLAXIS MASTER in combination with erythritol powder (AIR FLOW Powder Plus) will be used every month for 2 years for subgingival cleaning</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Air-Flow Prophylaxis Master</intervention_name>
      <description>AIR-FLOW PROPHYLAXIS MASTER in combination with erythritol powder (AIR FLOW Powder Plus) will be used every month for 2 years for subgingival cleaning according to the manufacturer's procedures.</description>
      <arm_group_label>Control procedure</arm_group_label>
      <arm_group_label>Test procedure</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Subjects about to undergo fixed orthodontic treatment will be invited to participate.&#xD;
               As the age of the study population will be between 12 and 16 years, only participants&#xD;
               from whom informed written consent will be obtained by their parents, will be included&#xD;
               in the study.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  • Clinically significant concomitant disease states (e.g., renal failure, hepatic&#xD;
               dysfunction, cardiovascular disease, etc.),&#xD;
  &#xD;
                 -  Known or suspected non-compliance, drug or alcohol abuse&#xD;
  &#xD;
                 -  Inability to follow the procedures of the investigation, e.g. due to language&#xD;
                    problems, psychological disorders, dementia, etc. of the subject&#xD;
  &#xD;
                 -  Participation in another investigation with an investigational drug or another MD&#xD;
                    within the 30 days preceding and during the present investigation&#xD;
  &#xD;
                 -  Previous enrolment into the current investigation&#xD;
  &#xD;
                 -  Enrolment of the PI, his/her family members, employees and other dependent&#xD;
                    persons&#xD;
  &#xD;
                 -  History of fixed orthodontic treatment&#xD;
  &#xD;
                 -  Defects on enamel on labial surfaces of the teeth&#xD;
  &#xD;
                 -  Untreated cavitated lesions&#xD;
  &#xD;
                 -  Plaque levels &gt;25%&#xD;
  &#xD;
                 -  Periodontitis&#xD;
  &#xD;
                 -  Multiple missing teeth&#xD;
  &#xD;
                 -  Cleft lip and/or palate or other craniofacial anomalies or syndromes&#xD;
  &#xD;
                 -  Patients taking any regular medication&#xD;
  &#xD;
                 -  Patients with asthmatic problems&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>16 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>University of Geneva, University Clinics of Dental Medicine</name>
        <address>
          <city>Geneva</city>
          <zip>1205</zip>
          <country>Switzerland</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Switzerland</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>July 14, 2023</study_first_submitted>
    <study_first_submitted_qc>August 4, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 4, 2023</last_update_submitted>
    <last_update_submitted_qc>August 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>University of Geneva, Switzerland</investigator_affiliation>
      <investigator_full_name>Catherine Giannopoulou</investigator_full_name>
      <investigator_title>Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Gingivitis</mesh_term>
      <mesh_term>Inflammation</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Undecided</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT05989750
  org study id: BASEC 2023-D0032
  nct id: NCT05989750
  lead sponsor: 
  collaborator: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Patients with multi-bracketed fixed orthodontic treatment are at increased risk of developing
        white spot lesions (WSL) and gingivitis. Various preventive strategies have been examined to
        prevent the development of WSLs. During initial non-surgical periodontal therapy, the use of
        subgingival air-polishing with erythritol powder has shown promising results in reducing deep
        pockets and gingival inflammation. The efficacy of its use as monotherapy in preventing WSLs
        and gingival inflammation in patients during orthodontic treatment, has not yet been tested.
  
        The primary objective of the present study is to compare the effectiveness of an
        air-polishing device used as monotherapy versus ultrasonic instrumentation (the current gold
        standard procedure) in preventing white spot lesions (WSL) and gingivitis among young
        patients undergoing multi-bracketed fixed orthodontic treatment.
  This is a randomized clinical study for evaluating the performance of an air-polishing device
        in preventing WSLs and gingivitis among patients undergoing multi-bracketed fixed orthodontic
        treatment. The null hypothesis tested is that there is no difference between the
        air-polishing device and the conventional ultrasonic device in preventing WSLs and gingivitis
        during orthodontic treatment.
  
        Clinical examination and clinical samples will be taken before, during and after orthodontic
        treatment. It is a single center study of 3 years duration involving samples of 60 patients
        attending the Division of Orthodontics for treatment. Half of the participants will be
        randomly assigned for treatment with the air-polishing device in every orthodontic
        appointment, meaning once per month, the other half will be treated with a standard
        ultrasonic scaler every six months. The study duration for each participant will be
        approximately 2 years. The investigators will then analyze the prevalence of WSLs using the
        Quantitative light-induced fluorescence (QLF) method. Gingivitis will be evaluated throughout
        the study by using standard clinical parameters; the antimicrobial efficacy against several
        known periodontal pathogens and the host-response (inflammatory markers in GCF) will be
        measured by the qPCR assay and the multiplex immunoassay, respectively. Clinical evaluation
        and collection of samples for microbial and host response analysis will be performed every 6
        months. Incidence of bracket debonding we will be calculated and compared.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Randomized, examiner-masked clinical trial
  primary purpose: Treatment
  masking: Single (Investigator)
  masking description: The examiner, the biostatistician and people working in the laboratory for the analyses, will be blinded for allocation group. Only the operator and the participant will be aware of the type of treatment based on the computer-generated allocation table that will be kept at the Trial Master File (TMF) of the study.
  measure: Appearance of white spot lesions (WSL) during orthodontic movement with fixed appliances.
  time frame: 2 years
  description: the formation of white spot lesions during the 2-years period of orthodontic treatment
  measure: Appearance on inflammatory lesions during orthodontic treatmnet
  time frame: 2 years
  description: Signs of inflammation based on clinical parameters during the 2-year period of orthodontic treatment
  measure: Changes from baseline in clinical parameters
  time frame: 2 years
  description: plaque accumulation gingival inflammation pocket probing depth bleeding on probing gingival recessions
  measure: Patient acceptance
  time frame: 2 years
  description: Visual Analogue Scale (VAS) with 0: very satisfied and 10: unsatisfied
  measure: Tooth sensitivity
  time frame: 2 years
  description: Visual Analogue Scale (VAS) with 0: no sensitivity and 10: worst senstitivity
  measure: Total bacterial counts and counts of 6 periodontal pathogens in subgingival samples from treated pockets
  time frame: 2 years
  description: Changes from baseline of microorganisms will be identified and enumerated by laboratory Real-time Polymerase Chain Reaction
  measure: Inflammatory markers in GCF from baseline
  time frame: 2 years
  description: Changes of the Inflammatory markers in the gingival crevicular fluid (GCF) throughout the study will be analyzed by the Bioplex 200 Suspension array system.
  measure: Toral tretament time
  time frame: 2 years
  description: Treatment time will be recorded at each visit
  arm group label: Control procedure
  arm group type: Active Comparator
  description: Ultrasonic scaling and polishing will be performed every 6 months for subgingival cleaning
  arm group label: Test procedure
  arm group type: Experimental
  description: AIR-FLOW PROPHYLAXIS MASTER in combination with erythritol powder (AIR FLOW Powder Plus) will be used every month for 2 years for subgingival cleaning
  intervention type: Device
  intervention name: Air-Flow Prophylaxis Master
  description: AIR-FLOW PROPHYLAXIS MASTER in combination with erythritol powder (AIR FLOW Powder Plus) will be used every month for 2 years for subgingival cleaning according to the manufacturer's procedures.
  arm group label: Control procedure
  arm group label: Test procedure
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 16 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Switzerland
  responsible party type: Sponsor-Investigator
  investigator affiliation: University of Geneva, Switzerland
  investigator full name: Catherine Giannopoulou
  investigator title: Professor
  mesh term: Gingivitis
  mesh term: Inflammation
  sharing ipd: Undecided