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/NCT06033859</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY22060166</org_study_id>
      <nct_id>NCT06033859</nct_id>
    </id_info>
    <brief_title>Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression: A Prospective Study</brief_title>
    <acronym>BOP</acronym>
    <official_title>Incidence of Bleeding on Probing as an Indicator of Peri-Implant Disease Progression: A Prospective Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Pittsburgh</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>University of Pittsburgh</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 primary goal of the present prospective cohort study is to evaluate the effect of varying&#xD;
        incidences of BOP at implant sites across 15 months of maintenance visits on the probability&#xD;
        of peri-implant disease progression. Over 15 months, participants will attend 6 visits where&#xD;
        clinical measurements and maintenance care will be performed every 3 months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Screening/Baseline/Maintenance Visit 1 (V1) After participants have consented, their health&#xD;
        history will be reviewed, and their vitals including blood pressure and heart rate will be&#xD;
        recorded. A dental exam of the teeth and gums will be completed. During this exam, a UNC 15&#xD;
        periodontal probe will be used to perform the clinical assessments. Intraoral photographs&#xD;
        (not identifiable) will be taken. An x-ray of the implant(s) included in the study will be&#xD;
        taken using a customized x-ray holder (created during Visit 1) so that at the end of the&#xD;
        study, a final x-ray will be taken in the exact same position. Finally, each participant will&#xD;
        receive a dental prophylaxis (D1110) or maintenance (D4910) according to their prior&#xD;
        periodontal diagnosis. This visit will take approximately 2-2.5 hours.&#xD;
  &#xD;
        Maintenance Visits 2-6 (V2-V6) Participants will return in 3-month intervals at approximately&#xD;
        3, 6, 9, 12, and 15 months (+/- 10 days) for Study Visits V2 - V6. At each of these visits,&#xD;
        individuals will be asked about continued participation in the study. Participants will also&#xD;
        be asked if there have been any changes to medical or dental history and if they are taking&#xD;
        any new medications. Vitals including blood pressure and heart rate will be recorded.&#xD;
        Intraoral photographs (not identifiable) of the study area will be performed, as well as,&#xD;
        collecting measurements from around the dental implant(s), and providing regular dental&#xD;
        cleaning. At the 15 month visit, a final x-ray will be taken using the custom x-ray holder&#xD;
        made at the first visit. These visits will take approximately 1.5-2 hours each. The final&#xD;
        visit will take approximately 2-2.5 hours.&#xD;
  &#xD;
        Clinical and radiographic assessments will include:&#xD;
  &#xD;
          1. BOP: at each of the 4 measured locations surrounding the implant of interest will be&#xD;
             recorded according to Mombelli et al. (1987):&#xD;
  &#xD;
               1. Score 0 - No BOP&#xD;
  &#xD;
               2. Score 1 - Bleeding dot&#xD;
  &#xD;
               3. Score 2 - Continuous line of blood that fills the sulcus&#xD;
  &#xD;
               4. Score 3 - Profuse bleeding and/or hemorrhage drip.&#xD;
  &#xD;
          2. Probing depths (PD): at 4 locations surrounding the implant of interest (mesiolingual&#xD;
             (ML), mesiobuccal (MB), distolingual (DL), and distobuccal (DB)). PD increase must&#xD;
             exceed a threshold of 0.8mm to be considered progression.&#xD;
  &#xD;
          3. Recession: measured at each of the 4 locations surrounding the implant of interest.&#xD;
  &#xD;
          4. Keratinized mucosa width: measured at the midbuccal aspect of the implant(s).&#xD;
  &#xD;
          5. Mucosal thickness: assessed with the aid of an endodontic spreader, 2mm below the&#xD;
             mucosal margin, at the midbuccal aspect of the implant(s).&#xD;
  &#xD;
          6. Marginal bone loss (MBL): measured by overlaying the baseline and final radiographs and&#xD;
             measuring the change in marginal bone levels. Progression will have to exceed a&#xD;
             threshold of 0.5mm to be considered.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">December 2025</completion_date>
    <primary_completion_date type="Anticipated">December 2025</primary_completion_date>
    <study_type>Observational</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <primary_outcome>
      <measure>Marginal Bone Loss (MBL)</measure>
      <time_frame>Baseline and 15 months</time_frame>
      <description>MBL will be calculated by measuring the difference in marginal bone level between the standardized periapical radiographs. Progression will have to exceed a threshold of 0.5mm to be considered.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Incidence of BOP</measure>
      <time_frame>3, 6, 9, 12 and 15 months</time_frame>
      <description>Changes in BOP at each of the 4 sites assessed in baseline, according to Mombelli et al. (1987):&#xD;
  Score 0 - No BOP&#xD;
  Score 1 - Bleeding dot&#xD;
  Score 2 - Continuous line of blood that fills the sulcus&#xD;
  Score 3 - Profuse bleeding and/or hemorrhage drip.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Changes in probing depth (PD)</measure>
      <time_frame>Baseline, 3, 6, 9, 12 and 15 months</time_frame>
      <description>Differences in probing depth over the study period. PD increase must exceed a threshold of 0.8mm to be considered progression.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Mucosal recession</measure>
      <time_frame>Baseline, 3, 6, 9, 12 and 15 months</time_frame>
      <description>Measured at each of the 4 locations surrounding the implant of interest.</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Peri-implant mucosal phenotype</measure>
      <time_frame>Baseline and 15 months</time_frame>
      <description>Assessed by determining the keratinized mucosa (KM) width, measured in millimeters with a periodontal probe, at the mid-buccal aspect of the implant from the gingival margin to the mucogingival junction and the mucosal thickness, measured in millimeters, at the mid-buccal aspect of the implant, 1.5mm below the gingival margin with an endodontic spreader (0.25mm diameter) and endodontic cursor.</description>
    </other_outcome>
    <number_of_groups>4</number_of_groups>
    <enrollment type="Anticipated">150</enrollment>
    <condition>Peri-Implantitis</condition>
    <condition>Bleeding of Subgingival Space</condition>
    <arm_group>
      <arm_group_label>Implants with BOP score 0</arm_group_label>
      <description>Implants with no BOP according to the modified bleeding index (Mombelli et al. 1987) at baseline.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Implants with BOP score 1</arm_group_label>
      <description>Implants with a bleeding dot (Mombelli et al. 1987) at baseline.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Implants with BOP score 2</arm_group_label>
      <description>Implants with a continuous line of blood that fills the sulcus (Mombelli et al. 1987) at baseline.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Implants with BOP score 3</arm_group_label>
      <description>Implants with a profuse bleeding and/or hemorrhage drip (Mombelli et al. 1987) at baseline.</description>
    </arm_group>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Clinical measurements</intervention_name>
      <description>With the aid of a periodontal probe, the incidence of BOP, as well as PD, recession and KM will be assessed.</description>
      <arm_group_label>Implants with BOP score 0</arm_group_label>
      <arm_group_label>Implants with BOP score 1</arm_group_label>
      <arm_group_label>Implants with BOP score 2</arm_group_label>
      <arm_group_label>Implants with BOP score 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Diagnostic Test</intervention_type>
      <intervention_name>Radiographic measurement</intervention_name>
      <description>A standardized periapical radiograph of the implant will be completed at the beginning and the end of study to determine the marginal bone loss.</description>
      <arm_group_label>Implants with BOP score 0</arm_group_label>
      <arm_group_label>Implants with BOP score 1</arm_group_label>
      <arm_group_label>Implants with BOP score 2</arm_group_label>
      <arm_group_label>Implants with BOP score 3</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Dental prophylaxis or maintenance</intervention_name>
      <description>Dental prophylaxis or maintenance will be performed every 3 months.</description>
      <arm_group_label>Implants with BOP score 0</arm_group_label>
      <arm_group_label>Implants with BOP score 1</arm_group_label>
      <arm_group_label>Implants with BOP score 2</arm_group_label>
      <arm_group_label>Implants with BOP score 3</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          The population from which cases will be recruited are from the patients of record at the&#xD;
          University of Pittsburgh Periodontics Department who meet the inclusion criteria of the&#xD;
          study.&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          To be enrolled in the study, the participant must meet the following inclusion criteria:&#xD;
  &#xD;
            -  adults in good general health (at least ASA 2)&#xD;
  &#xD;
            -  having ≥ 1 dental implant that was restored before January 2021&#xD;
  &#xD;
            -  patients of the University of Pittsburgh Periodontics Department&#xD;
  &#xD;
            -  available for maintenance visits every 3 months for the length of the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Active infectious diseases of any kind&#xD;
  &#xD;
            -  Pregnant or planning to become pregnant (self-reported)&#xD;
  &#xD;
            -  Congenital or metabolic bone disorders&#xD;
  &#xD;
            -  Current heavy smokers: Subjects who have smoked more than 1 pack/day within 6 months&#xD;
               of study onset&#xD;
  &#xD;
            -  Co-morbid conditions that would affect the study outcome or interpretation of study&#xD;
               results&#xD;
  &#xD;
            -  Require treatment for periodontal disease prior to baseline&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>80 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Andrea Ravida, DDS MS</last_name>
      <role>Principal Investigator</role>
      <affiliation>University of Pittsburgh</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Andrea Ravida, DDS MS</last_name>
      <phone>734-730-9678</phone>
      <email>andrearavida@pitt.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Carla Sanchez, MS</last_name>
      <phone>412-624-1179</phone>
      <email>cab28@pitt.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>University of Pittsburgh School of Dental Medicine</name>
        <address>
          <city>Pittsburgh</city>
          <state>Pennsylvania</state>
          <zip>15213</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Andrea Ravida, DDS, MS</last_name>
        <phone>734-730-9678</phone>
        <email>andrearavida@pitt.edu</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>September 5, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 13, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 13, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>University of Pittsburgh</investigator_affiliation>
      <investigator_full_name>Andrea Ravida</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <keyword>Bleeding on probing</keyword>
    <keyword>Peri-implant mucositis</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peri-Implantitis</mesh_term>
      <mesh_term>Hemorrhage</mesh_term>
      <mesh_term>Disease Progression</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</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/NCT06033859
  org study id: STUDY22060166
  nct id: NCT06033859
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The primary goal of the present prospective cohort study is to evaluate the effect of varying
        incidences of BOP at implant sites across 15 months of maintenance visits on the probability
        of peri-implant disease progression. Over 15 months, participants will attend 6 visits where
        clinical measurements and maintenance care will be performed every 3 months.
  Screening/Baseline/Maintenance Visit 1 (V1) After participants have consented, their health
        history will be reviewed, and their vitals including blood pressure and heart rate will be
        recorded. A dental exam of the teeth and gums will be completed. During this exam, a UNC 15
        periodontal probe will be used to perform the clinical assessments. Intraoral photographs
        (not identifiable) will be taken. An x-ray of the implant(s) included in the study will be
        taken using a customized x-ray holder (created during Visit 1) so that at the end of the
        study, a final x-ray will be taken in the exact same position. Finally, each participant will
        receive a dental prophylaxis (D1110) or maintenance (D4910) according to their prior
        periodontal diagnosis. This visit will take approximately 2-2.5 hours.
  
        Maintenance Visits 2-6 (V2-V6) Participants will return in 3-month intervals at approximately
        3, 6, 9, 12, and 15 months (+/- 10 days) for Study Visits V2 - V6. At each of these visits,
        individuals will be asked about continued participation in the study. Participants will also
        be asked if there have been any changes to medical or dental history and if they are taking
        any new medications. Vitals including blood pressure and heart rate will be recorded.
        Intraoral photographs (not identifiable) of the study area will be performed, as well as,
        collecting measurements from around the dental implant(s), and providing regular dental
        cleaning. At the 15 month visit, a final x-ray will be taken using the custom x-ray holder
        made at the first visit. These visits will take approximately 1.5-2 hours each. The final
        visit will take approximately 2-2.5 hours.
  
        Clinical and radiographic assessments will include:
  
          1. BOP: at each of the 4 measured locations surrounding the implant of interest will be
             recorded according to Mombelli et al. (1987):
  
               1. Score 0 - No BOP
  
               2. Score 1 - Bleeding dot
  
               3. Score 2 - Continuous line of blood that fills the sulcus
  
               4. Score 3 - Profuse bleeding and/or hemorrhage drip.
  
          2. Probing depths (PD): at 4 locations surrounding the implant of interest (mesiolingual
             (ML), mesiobuccal (MB), distolingual (DL), and distobuccal (DB)). PD increase must
             exceed a threshold of 0.8mm to be considered progression.
  
          3. Recession: measured at each of the 4 locations surrounding the implant of interest.
  
          4. Keratinized mucosa width: measured at the midbuccal aspect of the implant(s).
  
          5. Mucosal thickness: assessed with the aid of an endodontic spreader, 2mm below the
             mucosal margin, at the midbuccal aspect of the implant(s).
  
          6. Marginal bone loss (MBL): measured by overlaying the baseline and final radiographs and
             measuring the change in marginal bone levels. Progression will have to exceed a
             threshold of 0.5mm to be considered.
  observational model: Cohort
  time perspective: Prospective
  measure: Marginal Bone Loss (MBL)
  time frame: Baseline and 15 months
  description: MBL will be calculated by measuring the difference in marginal bone level between the standardized periapical radiographs. Progression will have to exceed a threshold of 0.5mm to be considered.
  measure: Incidence of BOP
  time frame: 3, 6, 9, 12 and 15 months
  description: Changes in BOP at each of the 4 sites assessed in baseline, according to Mombelli et al. (1987):
  Score 0 - No BOP
  Score 1 - Bleeding dot
  Score 2 - Continuous line of blood that fills the sulcus
  Score 3 - Profuse bleeding and/or hemorrhage drip.
  measure: Changes in probing depth (PD)
  time frame: Baseline, 3, 6, 9, 12 and 15 months
  description: Differences in probing depth over the study period. PD increase must exceed a threshold of 0.8mm to be considered progression.
  measure: Mucosal recession
  time frame: Baseline, 3, 6, 9, 12 and 15 months
  description: Measured at each of the 4 locations surrounding the implant of interest.
  measure: Peri-implant mucosal phenotype
  time frame: Baseline and 15 months
  description: Assessed by determining the keratinized mucosa (KM) width, measured in millimeters with a periodontal probe, at the mid-buccal aspect of the implant from the gingival margin to the mucogingival junction and the mucosal thickness, measured in millimeters, at the mid-buccal aspect of the implant, 1.5mm below the gingival margin with an endodontic spreader (0.25mm diameter) and endodontic cursor.
  arm group label: Implants with BOP score 0
  description: Implants with no BOP according to the modified bleeding index (Mombelli et al. 1987) at baseline.
  arm group label: Implants with BOP score 1
  description: Implants with a bleeding dot (Mombelli et al. 1987) at baseline.
  arm group label: Implants with BOP score 2
  description: Implants with a continuous line of blood that fills the sulcus (Mombelli et al. 1987) at baseline.
  arm group label: Implants with BOP score 3
  description: Implants with a profuse bleeding and/or hemorrhage drip (Mombelli et al. 1987) at baseline.
  intervention type: Diagnostic Test
  intervention name: Clinical measurements
  description: With the aid of a periodontal probe, the incidence of BOP, as well as PD, recession and KM will be assessed.
  arm group label: Implants with BOP score 0
  arm group label: Implants with BOP score 1
  arm group label: Implants with BOP score 2
  arm group label: Implants with BOP score 3
  intervention type: Diagnostic Test
  intervention name: Radiographic measurement
  description: A standardized periapical radiograph of the implant will be completed at the beginning and the end of study to determine the marginal bone loss.
  arm group label: Implants with BOP score 0
  arm group label: Implants with BOP score 1
  arm group label: Implants with BOP score 2
  arm group label: Implants with BOP score 3
  intervention type: Procedure
  intervention name: Dental prophylaxis or maintenance
  description: Dental prophylaxis or maintenance will be performed every 3 months.
  arm group label: Implants with BOP score 0
  arm group label: Implants with BOP score 1
  arm group label: Implants with BOP score 2
  arm group label: Implants with BOP score 3
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 80 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Andrea Ravida, DDS MS
  role: Principal Investigator
  affiliation: University of Pittsburgh
  last name: Andrea Ravida, DDS MS
  phone: 734-730-9678
  email: andrearavida@pitt.edu
  last name: Carla Sanchez, MS
  phone: 412-624-1179
  email: cab28@pitt.edu
  facility: 
  status: Recruiting
  contact: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: University of Pittsburgh
  investigator full name: Andrea Ravida
  investigator title: Assistant Professor
  mesh term: Peri-Implantitis
  mesh term: Hemorrhage
  mesh term: Disease Progression
  sharing ipd: No