<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/NCT03801187</url>
  </required_header>
  <id_info>
    <org_study_id>peri-implant surgical-1</org_study_id>
    <nct_id>NCT03801187</nct_id>
  </id_info>
  <brief_title>Surgical Protocol for Peri-implantitis Treatment</brief_title>
  <official_title>Surgical Protocol for Peri-implantitis in Horizontal Defect With Keratinised Tissue Using Er:YAG Laser or an Air-abrasive Device in Addition to Chlorhexidine: a Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Università Vita-Salute San Raffaele</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Università Vita-Salute San Raffaele</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>
      Peri-implant diseases are common post-restorative complications in implant rehabilitations&#xD;
      and they occur with an incidence of 12-43%.&#xD;
&#xD;
      Based on the available data in literature, the surgical therapy for peri-implantitis is&#xD;
      effective in disease resolution. Surgical access to peri-implant lesions facilitates the&#xD;
      removal of all granulation tissue from the defect area as well as debridement and&#xD;
      decontamination of the exposed implant surface defect area.&#xD;
&#xD;
      Different techniques have been used for implant surface decontamination during peri-implant&#xD;
      surgery, including mechanical, chemical and laser treatments.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Peri-implantitis are defined as inflammatory diseases caused by bacterial biofilm around&#xD;
      implant surface characterized by bleeding on probing, probing depth and eventually bone loss;&#xD;
      if not successfully treated they may lead to implant loss. Based on the available parameters&#xD;
      that have been reported in literature non surgical therapy doesn't seem to be effective on&#xD;
      peri-implantitis. Therefore it is recommended to consider advanced therapies such as surgical&#xD;
      interventions when non surgical peri-implant therapy fails to achieve significant&#xD;
      improvements in clinical parameters.&#xD;
&#xD;
      Numerous approaches have been used for implant surface decontamination during peri-implant&#xD;
      surgery, including mechanical, chemical and laser treatments.&#xD;
&#xD;
      Conventional mechanical means don't seem to be effective on peri-implant diseases. In&#xD;
      addition, the rough implant surface is a retentive factor for bacterial colonization and&#xD;
      therefore makes implant surface difficult to debride.&#xD;
&#xD;
      A treatment protocol that may offer an advantage over traditional mechanical treatment&#xD;
      includes the use of laser therapy and air-powder devices. Data have shown that treatments&#xD;
      with Er.Yag laser have a bactericidal effect and are safe and effective on implant surfaces.&#xD;
      Slightly better clinical results in terms of debridement, probing depth, bleeding on probing&#xD;
      and clinical attachment level have been reported by Er:Yag laser treatment compared with&#xD;
      traditional non surgical mechanical debridement with titanium curettes and pellet with saline&#xD;
      in the surgical treatment of peri-implantitis.&#xD;
&#xD;
      The air abrasive method for debridement has also been used on implant surfaces demonstrating&#xD;
      no relevant adverse effect. Until now, powders based on sodium bicarbonate and glycine have&#xD;
      been used with pressured air/water. Nowadays a less abrasive method involves the use of&#xD;
      erythritol powder.&#xD;
&#xD;
      The aim of the present randomized controlled clinical trial is to assess the efficacy in&#xD;
      improving clinical parameters of two further methods of implant decontamination (er:Yag laser&#xD;
      or air-abrasive device) after chemical treatment and chemical cleaning during surgical&#xD;
      treatment of peri-implantitis in addition to chlorhexidine in horizontal defects with&#xD;
      keratinised tissue around implant surfaces.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">July 2, 2018</start_date>
  <completion_date type="Anticipated">December 31, 2021</completion_date>
  <primary_completion_date type="Anticipated">December 30, 2020</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>Single (Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Bleeding on probing changes</measure>
    <time_frame>baseline, 3, 6 and 12 months after treatment</time_frame>
    <description>changes of bleeding on probing, evaluated as present if bleeding will be evident within 30 s after probing, or absent, if no bleeding will be noticed within 30 s after probing,</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>clinical attachment level changes</measure>
    <time_frame>baseline, 3, 6 and 12 months after treatment</time_frame>
    <description>changes in clinical attachment level, measured from CEJ to the tip of the probe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>probing pocket depth changes</measure>
    <time_frame>baseline, 3, 6 and 12 months after treatment</time_frame>
    <description>changes in probing depth probing, measured from gingival margin to te tip of the probe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>mucosal recession changes</measure>
    <time_frame>baseline, 3, 6 and 12 months after treatment</time_frame>
    <description>changes in mucosal recession, measured from CEJ to gingival margin</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>bone level changes</measure>
    <time_frame>baseline and 12 months after treatment</time_frame>
    <description>changes in bone level at mesial and distal aspect, measured on periapical X-ray</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Anticipated">45</enrollment>
  <condition>Peri-implantitis</condition>
  <arm_group>
    <arm_group_label>Chlorhexidine</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>Access flap will be raised to gain access to the implant surface. Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in Chlorhexidine.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Er:YAG laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Er: Yag laser treatment will be provided on the implant surface.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Air Powder</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>An Air-Powder treatment will be provided on the implant surface</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>chlorhexidine</intervention_name>
    <description>Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in chlorhexidine.</description>
    <arm_group_label>Air Powder</arm_group_label>
    <arm_group_label>Chlorhexidine</arm_group_label>
    <arm_group_label>Er:YAG laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Er:YAG laser</intervention_name>
    <description>Er.YAg laser treatment will be provided on the implant surface.</description>
    <arm_group_label>Er:YAG laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Air-Powder</intervention_name>
    <description>An air powder device will be treatment will be provided on the implant surface.</description>
    <arm_group_label>Air Powder</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  presence of at least one screw-type titanium implant exhibiting bleeding and/or&#xD;
             suppuration on probing combined with:&#xD;
&#xD;
               1. PPD ≥ 5 mm and bone loss ≥ 2 mm (compared to crestal bone levels at the time of&#xD;
                  placement of the reconstruction)&#xD;
&#xD;
               2. PPD ≥6 and bone loss ≥3 (not compared to crestal bone levels at the time of&#xD;
                  placement of the reconstruction)&#xD;
&#xD;
          -  single tooth and bridgework restorations without overhangs&#xD;
&#xD;
          -  no evidence of occlusal overload (i.e. occlusal contacts revealed appropriate&#xD;
             adjustment),&#xD;
&#xD;
          -  treated chronic periodontitis and proper periodontal maintenance care&#xD;
&#xD;
          -  FMPS &lt; 20%&#xD;
&#xD;
          -  non-smoker or light smoking status in smokers (&lt;10 cigarettes per day)&#xD;
&#xD;
          -  implant function time ≥ 1 year.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with uncontrolled diabetes&#xD;
&#xD;
          -  patients with osteoporosis or under bisphosphonate medication,&#xD;
&#xD;
          -  pregnant or lactating women&#xD;
&#xD;
          -  patients with a history of radiotherapy to the head and neck region&#xD;
&#xD;
          -  hollow implants&#xD;
&#xD;
          -  implant mobility&#xD;
&#xD;
          -  implants at which no position could be identified where proper probing measurements&#xD;
             could be performed;&#xD;
&#xD;
          -  previous surgical treatment of the peri-implantitis lesions&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Massimo De Sanctis, Prof.</last_name>
    <role>Study Chair</role>
    <affiliation>Università Vita-Salute San Raffaele</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Marco Clementini</last_name>
    <phone>0226432806</phone>
    <email>mclementini@me.com</email>
  </overall_contact>
  <location>
    <facility>
      <name>Università Vita-Salute San Raffaele</name>
      <address>
        <city>Milano</city>
        <zip>20100</zip>
        <country>Italy</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Marco Clementini</last_name>
      <email>mclementini@me.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Italy</country>
  </location_countries>
  <verification_date>November 2020</verification_date>
  <study_first_submitted>January 9, 2019</study_first_submitted>
  <study_first_submitted_qc>January 9, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 11, 2019</study_first_posted>
  <last_update_submitted>November 2, 2020</last_update_submitted>
  <last_update_submitted_qc>November 2, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">November 3, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Università Vita-Salute San Raffaele</investigator_affiliation>
    <investigator_full_name>Marco Clementini</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>peri-implantitis</keyword>
  <keyword>surgical treatment</keyword>
  <keyword>Er:Yag laser</keyword>
  <keyword>Air-flow</keyword>
  <keyword>chlorhexidine</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peri-Implantitis</mesh_term>
  </condition_browse>
  <intervention_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Chlorhexidine</mesh_term>
  </intervention_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03801187
org study id: peri-implant surgical-1
nct id: NCT03801187
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Peri-implant diseases are common post-restorative complications in implant rehabilitations
      and they occur with an incidence of 12-43%.

      Based on the available data in literature, the surgical therapy for peri-implantitis is
      effective in disease resolution. Surgical access to peri-implant lesions facilitates the
      removal of all granulation tissue from the defect area as well as debridement and
      decontamination of the exposed implant surface defect area.

      Different techniques have been used for implant surface decontamination during peri-implant
      surgery, including mechanical, chemical and laser treatments.
Peri-implantitis are defined as inflammatory diseases caused by bacterial biofilm around
      implant surface characterized by bleeding on probing, probing depth and eventually bone loss;
      if not successfully treated they may lead to implant loss. Based on the available parameters
      that have been reported in literature non surgical therapy doesn't seem to be effective on
      peri-implantitis. Therefore it is recommended to consider advanced therapies such as surgical
      interventions when non surgical peri-implant therapy fails to achieve significant
      improvements in clinical parameters.

      Numerous approaches have been used for implant surface decontamination during peri-implant
      surgery, including mechanical, chemical and laser treatments.

      Conventional mechanical means don't seem to be effective on peri-implant diseases. In
      addition, the rough implant surface is a retentive factor for bacterial colonization and
      therefore makes implant surface difficult to debride.

      A treatment protocol that may offer an advantage over traditional mechanical treatment
      includes the use of laser therapy and air-powder devices. Data have shown that treatments
      with Er.Yag laser have a bactericidal effect and are safe and effective on implant surfaces.
      Slightly better clinical results in terms of debridement, probing depth, bleeding on probing
      and clinical attachment level have been reported by Er:Yag laser treatment compared with
      traditional non surgical mechanical debridement with titanium curettes and pellet with saline
      in the surgical treatment of peri-implantitis.

      The air abrasive method for debridement has also been used on implant surfaces demonstrating
      no relevant adverse effect. Until now, powders based on sodium bicarbonate and glycine have
      been used with pressured air/water. Nowadays a less abrasive method involves the use of
      erythritol powder.

      The aim of the present randomized controlled clinical trial is to assess the efficacy in
      improving clinical parameters of two further methods of implant decontamination (er:Yag laser
      or air-abrasive device) after chemical treatment and chemical cleaning during surgical
      treatment of peri-implantitis in addition to chlorhexidine in horizontal defects with
      keratinised tissue around implant surfaces.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Bleeding on probing changes
time frame: baseline, 3, 6 and 12 months after treatment
description: changes of bleeding on probing, evaluated as present if bleeding will be evident within 30 s after probing, or absent, if no bleeding will be noticed within 30 s after probing,
measure: clinical attachment level changes
time frame: baseline, 3, 6 and 12 months after treatment
description: changes in clinical attachment level, measured from CEJ to the tip of the probe
measure: probing pocket depth changes
time frame: baseline, 3, 6 and 12 months after treatment
description: changes in probing depth probing, measured from gingival margin to te tip of the probe
measure: mucosal recession changes
time frame: baseline, 3, 6 and 12 months after treatment
description: changes in mucosal recession, measured from CEJ to gingival margin
measure: bone level changes
time frame: baseline and 12 months after treatment
description: changes in bone level at mesial and distal aspect, measured on periapical X-ray
arm group label: Chlorhexidine
arm group type: Sham Comparator
description: Access flap will be raised to gain access to the implant surface. Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in Chlorhexidine.
arm group label: Er:YAG laser
arm group type: Experimental
description: Er: Yag laser treatment will be provided on the implant surface.
arm group label: Air Powder
arm group type: Active Comparator
description: An Air-Powder treatment will be provided on the implant surface
intervention type: Procedure
intervention name: chlorhexidine
description: Inflammatory tissue, excess cement or plaque deposits will be removed using titanium curettes and the implant surface will be cleaned by copious irrigation with sterile saline and surgical gauze soaked in chlorhexidine.
arm group label: Air Powder
arm group label: Chlorhexidine
arm group label: Er:YAG laser
intervention type: Procedure
intervention name: Er:YAG laser
description: Er.YAg laser treatment will be provided on the implant surface.
arm group label: Er:YAG laser
intervention type: Procedure
intervention name: Air-Powder
description: An air powder device will be treatment will be provided on the implant surface.
arm group label: Air Powder
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Massimo De Sanctis, Prof.
role: Study Chair
affiliation: Università Vita-Salute San Raffaele
last name: Marco Clementini
phone: 0226432806
email: mclementini@me.com
facility: 
status: Recruiting
contact: 
country: Italy
responsible party type: Principal Investigator
investigator affiliation: Università Vita-Salute San Raffaele
investigator full name: Marco Clementini
investigator title: Principal Investigator
mesh term: Peri-Implantitis
mesh term: Chlorhexidine
sharing ipd: Undecided