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/NCT05964127</url>
    </required_header>
    <id_info>
      <org_study_id>EDGE ID 124712</org_study_id>
      <nct_id>NCT05964127</nct_id>
    </id_info>
    <brief_title>Peri-implantitis and Systemic Inflammation</brief_title>
    <acronym>LASSO</acronym>
    <official_title>Local and Systemic Effects of Peri-implantitis and Its Treatment (LASSO). A Randomised Controlled Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Eastman Dental Insitute and Hospital</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Eastman Dental Insitute and Hospital</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>
        To investigate the effects of peri-implantitis (a disease around dental implants) and its&#xD;
        treatment at both local and systemic levels using clinical and biological parameters.&#xD;
  &#xD;
        One study with two parts which will run simultaneously. An initial observational study&#xD;
        comparing cases and controls and a subsequent interventional study in which the cases will&#xD;
        proceed to treatments and all participants will be followed up for 6 months.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Dental implants provide the gold standard treatment modality for missing teeth in most&#xD;
        clinical situations. However, patient-related, site-related and clinician-related factors&#xD;
        play a significant part in the management of patents with edentulous spaces. As the provision&#xD;
        of implants increases worldwide and as patient life expectancy increases the long-term&#xD;
        maintenance of implants and their restorative components will be essential. Similar to&#xD;
        periodontal disease occurring in the periodontium around teeth there is an akin peri-implant&#xD;
        disease process occurring in the peri-implant mucosa around implants. The prevalence of&#xD;
        peri-implantitis in studies range from 1-47%, with an estimated weighted mean prevalence of&#xD;
        22%. Systematic analysis at implant-based and subjected-based levels shows prevalence's of&#xD;
        peri-implantitis of 9.25% and 19.83% respectively.&#xD;
  &#xD;
        Peri-implantitis is an inflammatory disease of the soft tissues around an osseointegrated&#xD;
        dental implant accompanied by bone loss beyond normal physiological remodelling. Like&#xD;
        periodontitis, peri-implantitis is the result of a host inflammatory response to a microbial&#xD;
        biofilm, which results in inflammation of the peri-implant connective tissue and progressive&#xD;
        bone loss. The current understanding, although limited, suggests that peri-implant disease is&#xD;
        a condition that, whilst having several traits in common with periodontal disease, is unique,&#xD;
        with distinctive features. Recent discoveries in microbiology opens a completely new&#xD;
        perspective on the aetiology of peri-implant disease and the further development of&#xD;
        metagenomics might open the way to new therapeutic approaches.&#xD;
  &#xD;
        Systemic inflammation plays a crucial role in a number of chronic disorders including&#xD;
        diabetes and cardiovascular diseases. There is consistent and substantial evidence proposing&#xD;
        that inflammation plays a causative role in the onset and progression of these chronic&#xD;
        disorders. Periodontitis is linked to systemic inflammation and effective periodontal&#xD;
        treatment resolves this host response. It is plausible to suggest that peri-implantitis could&#xD;
        well represent a similar inflammatory trigger for the host. Recent experimental human&#xD;
        evidence has confirmed peri-implantitis is associated with a larger mucosal inflammatory&#xD;
        infiltrate. This local mucosal response and possible bacterial dissemination, could be&#xD;
        triggering a systemic inflammatory response, as assessed by elevated levels of a common&#xD;
        inflammatory biomarkers, called C-reactive protein (CRP).&#xD;
  &#xD;
        With an inflammatory pathophysiology an exploration of key inflammatory biomarkers can help&#xD;
        in disease quantification. Whilst peri-implant crevicular fluid (PICF) will be an area to&#xD;
        assess for inflammatory biomarkers of peri-implantitis the focus is still on the blood-borne&#xD;
        systemic inflammatory challenge, specifically focusing on the acute-phase protein CRP. CRP is&#xD;
        a pentameric pattern recognition molecule which is extremely sensitive to the systemic&#xD;
        response to inflammation and regulated by key cytokines like Interleukin 6 (IL-6).&#xD;
  &#xD;
        Evidence on CRP specifically within peri-implant disease is lacking. However, studies which&#xD;
        use CRP to assist in the diagnosis of diseases around other implantable biomaterials i.e.&#xD;
        prosthetic hip and knee joint infections are available and show benefits when combined with&#xD;
        other diagnostic tests. Increased levels of CRP have been observed in gingivitis and&#xD;
        periodontitis reflecting the locally stressed environment. However, CRP levels fluctuate with&#xD;
        various confounding factors including aging, elevated triglycerides and insulin-resistance&#xD;
        diabetes. Clinical trials have also shown that treatment for periodontal infection with&#xD;
        intensive mechanical therapy can significantly lower the serum CRP levels.&#xD;
  &#xD;
        Currently the management of peri-implantitis is somewhat variable and relies on our knowledge&#xD;
        and understanding of the management of periodontitis. The need for implant surface&#xD;
        decontamination is unequivocal, however, the implant surface is incomparable to that of a&#xD;
        tooth root surface. Treatment options include, and often combine, non-surgical mechanical&#xD;
        instrumentation, with or without adjunctive antimicrobials, to surgeries ranging from simple&#xD;
        access flaps for open flap debridement, with or without osseous recontouring, to&#xD;
        implantoplasty and defect regeneration using biomaterials. Systematic reviews have attempted&#xD;
        to collate the evidence to provide some management clarity but fell short due to the&#xD;
        variability in peri-implantitis case definitions and high heterogeneity of included studies.&#xD;
        The challenges of successful instrumentation of implants is that the macro-topography has&#xD;
        voids which are smaller than the width of the narrowest surgical instruments. A novel&#xD;
        approach to this conundrum is the decontamination of the implant surface using an air-powder&#xD;
        abrasive system. Such a technique has been shown, under in vitro evaluation, to remove 99.9%&#xD;
        of bacteria from the test specimens.&#xD;
  &#xD;
        Peri-implantitis treatment is not currently as predictable as for periodontitis and there&#xD;
        must be a focus for innovative treatment approaches. We have strong evidence to support the&#xD;
        expected clinical outcomes of non-surgical periodontal therapy and access flap periodontal&#xD;
        surgery in periodontitis. The equivalent evidence in peri-implantitis treatment is lacking,&#xD;
        in part, due to the challenges of decontamination of an implant surface. The use of&#xD;
        air-powder abrasion systems may be an area worthy of further research to determine if this&#xD;
        technically appropriate treatment provides clinical evidence of success through appropriately&#xD;
        designed trials. The EMS designed PerioFlow system is such a system which combines&#xD;
        air-powder-water delivered through a multi-outlet, flexible, single-use nozzle.&#xD;
  &#xD;
        This study is therefore aimed at assessing the potential effects of peri-implantitis and&#xD;
        different treatment approaches on both peri-implant inflammation and systemic inflammation.&#xD;
        The study is conceived into two parts. One part investigating the association between&#xD;
        peri-implantitis and local and systemic inflammation as measured through systemic&#xD;
        inflammatory biomarkers, like CRP, in saliva, PICF and blood, but additionally reporting on&#xD;
        any differences in the clinical parameters, microbiology, soft tissue thickness and&#xD;
        vascularity between health and peri-implantitis. The second part focuses on three different&#xD;
        treatment modalities for peri-implantitis and compares the outcomes of these using the same&#xD;
        clinical, microbiological, immunological and vascular parameters.&#xD;
  &#xD;
        This study will allow us to identify any associations, quantify the effects, postulate the&#xD;
        potential clinical implications, evaluate clinical treatments and guide future interventional&#xD;
        studies.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">July 19, 2023</start_date>
    <completion_date type="Anticipated">December 31, 2025</completion_date>
    <primary_completion_date type="Anticipated">July 31, 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>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Inflammation</measure>
      <time_frame>6-months after treatment</time_frame>
      <description>Serum CRP</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Inflammation</measure>
      <time_frame>Baseline, 3 and 6-months after treatment</time_frame>
      <description>IL-6</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Endothelial Function</measure>
      <time_frame>Baseline, 3 and 6 months after treatment</time_frame>
      <description>FMD</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>OCT</measure>
      <time_frame>Baseline, 3 and 6 months after treatment</time_frame>
      <description>Gingival epithelial inflammatory status using Optical Coherence Tomography (OCT)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Blood flow</measure>
      <time_frame>Baseline, 3 and 6 months</time_frame>
      <description>Gingival vascularity using Laser Speckle Contrast Imager (LSCI)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Gingival tissue thickness</measure>
      <time_frame>Baseline, 3 and 6 months after treatment</time_frame>
      <description>Ultrasound gingival assessment</description>
    </secondary_outcome>
    <number_of_arms>3</number_of_arms>
    <enrollment type="Anticipated">138</enrollment>
    <condition>Peri-Implantitis and Systemic Inflammation</condition>
    <arm_group>
      <arm_group_label>Group A - Non-surgical hand instruments</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>After appropriate local anaesthesia of the treatment site supragingival, subgingival and implant surface debridement will be undertaken with Hu-Friedy titanium implant hand instruments only. Any remaining supragingival deposits will be polished using a contra-angle handpiece, rubber cup and Cleanic polishing paste.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group B - Non-surgical Air-flow</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>After appropriate local anaesthesia of the treatment site supragingival, subgingival and implant surface debridement will be undertaken using EMS PerioFlow with Plus powder (Erythritol) and supplemented with EMS Piezon and EMS AirFlow and Plus powder as required.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Group C - Surgical Air-flow</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>After appropriate local anaesthesia of the treatment site a full thickness mucoperiosteal flap will be raised to adequately expose the tissue defect. Supragingival, subgingival and implant surface debridement will be undertaken using EMS PerioFlow with Plus powder (Erythritol) and supplemented with EMS Piezon and EMS AirFlow and Plus powder as required.</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>Air flow device</intervention_name>
      <description>An air/powder device for surface decontamination</description>
      <arm_group_label>Group B - Non-surgical Air-flow</arm_group_label>
      <arm_group_label>Group C - Surgical Air-flow</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Hand instruments</intervention_name>
      <description>Periodontal hand instruments</description>
      <arm_group_label>Group A - Non-surgical hand instruments</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Access flap surgery</intervention_name>
      <description>To improve the surgical access for implant decontamination</description>
      <arm_group_label>Group C - Surgical Air-flow</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  At least 18 years of age and in good general health&#xD;
  &#xD;
            -  A minimum of 20 teeth&#xD;
  &#xD;
            -  Participants must have at least one implant in situ with peri-implantitis as per its&#xD;
               case definition&#xD;
  &#xD;
            -  Must voluntarily agree to sign the consent form&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Currently on any weight reduction program&#xD;
  &#xD;
            -  History of diabetes&#xD;
  &#xD;
            -  Uncontrolled or currently undergoing treatment for systemic medical conditions&#xD;
  &#xD;
            -  Chronic treatment (defined as 2 weeks or more) of antibiotic, anti-inflammatory or&#xD;
               anticoagulant therapy during the month preceding the baseline assessment&#xD;
  &#xD;
            -  Taking statins drugs&#xD;
  &#xD;
            -  History of alcohol or drug abuse&#xD;
  &#xD;
            -  Self-reported pregnancy or breastfeeding&#xD;
  &#xD;
            -  Patients who have active periodontitis as per its case definition and/or have had&#xD;
               treatment for periodontitis within the last 1 year&#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_contact>
      <last_name>Jeanie Suvan</last_name>
      <phone>+442034561108</phone>
      <email>j.suvan@ucl.ac.uk</email>
    </overall_contact>
    <location>
      <facility>
        <name>University College London</name>
        <address>
          <city>London</city>
          <country>United Kingdom</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Jean Suvan</last_name>
        <email>j.suvan@ucl.ac.uk</email>
      </contact>
      <contact_backup>
        <last_name>Francesco D'Aiuto</last_name>
        <email>f.daiuto@ucl.ac.uk</email>
      </contact_backup>
      <investigator>
        <last_name>Francesco D'Aiuto</last_name>
        <role>Principal Investigator</role>
      </investigator>
      <investigator>
        <last_name>Jeanie Suvan</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Marco Orlandi</last_name>
        <role>Sub-Investigator</role>
      </investigator>
      <investigator>
        <last_name>Yumeng Yan</last_name>
        <role>Sub-Investigator</role>
      </investigator>
    </location>
    <location_countries>
      <country>United Kingdom</country>
    </location_countries>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>December 11, 2020</study_first_submitted>
    <study_first_submitted_qc>July 19, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">July 27, 2023</study_first_posted>
    <last_update_submitted>July 19, 2023</last_update_submitted>
    <last_update_submitted_qc>July 19, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">July 27, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Eastman Dental Insitute and Hospital</investigator_affiliation>
      <investigator_full_name>Prof Francesco D'Aiuto</investigator_full_name>
      <investigator_title>Professor &amp; Head of Department of Periodontology</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Peri-Implantitis</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/NCT05964127
  org study id: EDGE ID 124712
  nct id: NCT05964127
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  To investigate the effects of peri-implantitis (a disease around dental implants) and its
        treatment at both local and systemic levels using clinical and biological parameters.
  
        One study with two parts which will run simultaneously. An initial observational study
        comparing cases and controls and a subsequent interventional study in which the cases will
        proceed to treatments and all participants will be followed up for 6 months.
  Dental implants provide the gold standard treatment modality for missing teeth in most
        clinical situations. However, patient-related, site-related and clinician-related factors
        play a significant part in the management of patents with edentulous spaces. As the provision
        of implants increases worldwide and as patient life expectancy increases the long-term
        maintenance of implants and their restorative components will be essential. Similar to
        periodontal disease occurring in the periodontium around teeth there is an akin peri-implant
        disease process occurring in the peri-implant mucosa around implants. The prevalence of
        peri-implantitis in studies range from 1-47%, with an estimated weighted mean prevalence of
        22%. Systematic analysis at implant-based and subjected-based levels shows prevalence's of
        peri-implantitis of 9.25% and 19.83% respectively.
  
        Peri-implantitis is an inflammatory disease of the soft tissues around an osseointegrated
        dental implant accompanied by bone loss beyond normal physiological remodelling. Like
        periodontitis, peri-implantitis is the result of a host inflammatory response to a microbial
        biofilm, which results in inflammation of the peri-implant connective tissue and progressive
        bone loss. The current understanding, although limited, suggests that peri-implant disease is
        a condition that, whilst having several traits in common with periodontal disease, is unique,
        with distinctive features. Recent discoveries in microbiology opens a completely new
        perspective on the aetiology of peri-implant disease and the further development of
        metagenomics might open the way to new therapeutic approaches.
  
        Systemic inflammation plays a crucial role in a number of chronic disorders including
        diabetes and cardiovascular diseases. There is consistent and substantial evidence proposing
        that inflammation plays a causative role in the onset and progression of these chronic
        disorders. Periodontitis is linked to systemic inflammation and effective periodontal
        treatment resolves this host response. It is plausible to suggest that peri-implantitis could
        well represent a similar inflammatory trigger for the host. Recent experimental human
        evidence has confirmed peri-implantitis is associated with a larger mucosal inflammatory
        infiltrate. This local mucosal response and possible bacterial dissemination, could be
        triggering a systemic inflammatory response, as assessed by elevated levels of a common
        inflammatory biomarkers, called C-reactive protein (CRP).
  
        With an inflammatory pathophysiology an exploration of key inflammatory biomarkers can help
        in disease quantification. Whilst peri-implant crevicular fluid (PICF) will be an area to
        assess for inflammatory biomarkers of peri-implantitis the focus is still on the blood-borne
        systemic inflammatory challenge, specifically focusing on the acute-phase protein CRP. CRP is
        a pentameric pattern recognition molecule which is extremely sensitive to the systemic
        response to inflammation and regulated by key cytokines like Interleukin 6 (IL-6).
  
        Evidence on CRP specifically within peri-implant disease is lacking. However, studies which
        use CRP to assist in the diagnosis of diseases around other implantable biomaterials i.e.
        prosthetic hip and knee joint infections are available and show benefits when combined with
        other diagnostic tests. Increased levels of CRP have been observed in gingivitis and
        periodontitis reflecting the locally stressed environment. However, CRP levels fluctuate with
        various confounding factors including aging, elevated triglycerides and insulin-resistance
        diabetes. Clinical trials have also shown that treatment for periodontal infection with
        intensive mechanical therapy can significantly lower the serum CRP levels.
  
        Currently the management of peri-implantitis is somewhat variable and relies on our knowledge
        and understanding of the management of periodontitis. The need for implant surface
        decontamination is unequivocal, however, the implant surface is incomparable to that of a
        tooth root surface. Treatment options include, and often combine, non-surgical mechanical
        instrumentation, with or without adjunctive antimicrobials, to surgeries ranging from simple
        access flaps for open flap debridement, with or without osseous recontouring, to
        implantoplasty and defect regeneration using biomaterials. Systematic reviews have attempted
        to collate the evidence to provide some management clarity but fell short due to the
        variability in peri-implantitis case definitions and high heterogeneity of included studies.
        The challenges of successful instrumentation of implants is that the macro-topography has
        voids which are smaller than the width of the narrowest surgical instruments. A novel
        approach to this conundrum is the decontamination of the implant surface using an air-powder
        abrasive system. Such a technique has been shown, under in vitro evaluation, to remove 99.9%
        of bacteria from the test specimens.
  
        Peri-implantitis treatment is not currently as predictable as for periodontitis and there
        must be a focus for innovative treatment approaches. We have strong evidence to support the
        expected clinical outcomes of non-surgical periodontal therapy and access flap periodontal
        surgery in periodontitis. The equivalent evidence in peri-implantitis treatment is lacking,
        in part, due to the challenges of decontamination of an implant surface. The use of
        air-powder abrasion systems may be an area worthy of further research to determine if this
        technically appropriate treatment provides clinical evidence of success through appropriately
        designed trials. The EMS designed PerioFlow system is such a system which combines
        air-powder-water delivered through a multi-outlet, flexible, single-use nozzle.
  
        This study is therefore aimed at assessing the potential effects of peri-implantitis and
        different treatment approaches on both peri-implant inflammation and systemic inflammation.
        The study is conceived into two parts. One part investigating the association between
        peri-implantitis and local and systemic inflammation as measured through systemic
        inflammatory biomarkers, like CRP, in saliva, PICF and blood, but additionally reporting on
        any differences in the clinical parameters, microbiology, soft tissue thickness and
        vascularity between health and peri-implantitis. The second part focuses on three different
        treatment modalities for peri-implantitis and compares the outcomes of these using the same
        clinical, microbiological, immunological and vascular parameters.
  
        This study will allow us to identify any associations, quantify the effects, postulate the
        potential clinical implications, evaluate clinical treatments and guide future interventional
        studies.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Inflammation
  time frame: 6-months after treatment
  description: Serum CRP
  measure: Inflammation
  time frame: Baseline, 3 and 6-months after treatment
  description: IL-6
  measure: Endothelial Function
  time frame: Baseline, 3 and 6 months after treatment
  description: FMD
  measure: OCT
  time frame: Baseline, 3 and 6 months after treatment
  description: Gingival epithelial inflammatory status using Optical Coherence Tomography (OCT)
  measure: Blood flow
  time frame: Baseline, 3 and 6 months
  description: Gingival vascularity using Laser Speckle Contrast Imager (LSCI)
  measure: Gingival tissue thickness
  time frame: Baseline, 3 and 6 months after treatment
  description: Ultrasound gingival assessment
  arm group label: Group A - Non-surgical hand instruments
  arm group type: Active Comparator
  description: After appropriate local anaesthesia of the treatment site supragingival, subgingival and implant surface debridement will be undertaken with Hu-Friedy titanium implant hand instruments only. Any remaining supragingival deposits will be polished using a contra-angle handpiece, rubber cup and Cleanic polishing paste.
  arm group label: Group B - Non-surgical Air-flow
  arm group type: Active Comparator
  description: After appropriate local anaesthesia of the treatment site supragingival, subgingival and implant surface debridement will be undertaken using EMS PerioFlow with Plus powder (Erythritol) and supplemented with EMS Piezon and EMS AirFlow and Plus powder as required.
  arm group label: Group C - Surgical Air-flow
  arm group type: Active Comparator
  description: After appropriate local anaesthesia of the treatment site a full thickness mucoperiosteal flap will be raised to adequately expose the tissue defect. Supragingival, subgingival and implant surface debridement will be undertaken using EMS PerioFlow with Plus powder (Erythritol) and supplemented with EMS Piezon and EMS AirFlow and Plus powder as required.
  intervention type: Device
  intervention name: Air flow device
  description: An air/powder device for surface decontamination
  arm group label: Group B - Non-surgical Air-flow
  arm group label: Group C - Surgical Air-flow
  intervention type: Other
  intervention name: Hand instruments
  description: Periodontal hand instruments
  arm group label: Group A - Non-surgical hand instruments
  intervention type: Procedure
  intervention name: Access flap surgery
  description: To improve the surgical access for implant decontamination
  arm group label: Group C - Surgical Air-flow
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Jeanie Suvan
  phone: +442034561108
  email: j.suvan@ucl.ac.uk
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  investigator: 
  investigator: 
  investigator: 
  investigator: 
  country: United Kingdom
  responsible party type: Principal Investigator
  investigator affiliation: Eastman Dental Insitute and Hospital
  investigator full name: Prof Francesco D'Aiuto
  investigator title: Professor & Head of Department of Periodontology
  mesh term: Peri-Implantitis
  mesh term: Inflammation
  sharing ipd: Undecided