<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/NCT03814434</url>
  </required_header>
  <id_info>
    <org_study_id>RiskFactorsSurgPeriimplantitis</org_study_id>
    <nct_id>NCT03814434</nct_id>
  </id_info>
  <brief_title>Surgical Treatment of Periimplantitis in Patients With Risk Factors</brief_title>
  <official_title>Surgical Treatment of Periimplantitis in Patients With Risk Factors: Heavy Smokers, Type 2 Diabetic and Chronic Periodontitis Patients</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Luiz Antonio Pugliesi Alves de Lima</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Sao Paulo</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>
      This study evaluates clinical and radiographic parameters among riks factor groups in&#xD;
      patients with periimplantitis. This study will also treat and evaluate the patients response&#xD;
      before and after surgical treatment.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Periimplantitis (PI) is an inflammatory process that results in tissue attachment bone loss&#xD;
      around the implant. Periodontal disease, smoke habit and type 2diabetes mellitus have been&#xD;
      recognized as potential risk factor indicators that might lead to complications establishment&#xD;
      and progression around dental implants. PI treatment predictability has been shown limited&#xD;
      and influenced by factors not totally clarified. The aim of this study is to evaluate the&#xD;
      reparative response after PI surgical treatment at clinical and radiographic levelsin risk&#xD;
      factors patients: type 2 diabetes mellitus, smokers and chronic periodontal disease.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">May 28, 2018</start_date>
  <completion_date type="Anticipated">January 28, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 28, 2020</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Non-Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <intervention_model_description>This is not a randomized study. All patients will entered the study after being diagnosed with periimplantitis. Patients will be allocated to different groups according to their condition: Heavy Smokers, Type 2 Diabetes Mellitus, Chronic periodontitis and systemically healthy patients (control group).</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
    <masking_description>Surgeon will not be aware of group being treated. Analyses of the data and statistics will not show explain what group has originated the data. Groups will be identified as A, B, C or D.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Radiographic Bone height Gain</measure>
    <time_frame>3 months</time_frame>
    <description>Radiographic Bone Height Gain Comparison to baseline 3 months after surgical treatment</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Periimplant Pocket probing depth</measure>
    <time_frame>3 months</time_frame>
    <description>Periimplant probing depth comparison to baseline 3 months after surgical treatment</description>
  </secondary_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">40</enrollment>
  <condition>Peri-Implantitis</condition>
  <condition>Type 2 Diabetes Mellitus</condition>
  <condition>Smoking, Cigarette</condition>
  <condition>Periodontal Diseases</condition>
  <arm_group>
    <arm_group_label>Smokers with Periimplantitis group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Heavy smokers patients with periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Type 2 Diabetes with Periimplantitis group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients diagnosed with Type 2 Diabetes with periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Chronic Periodontitis with Periimplantitis group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Patients diagnosed with Chronic Periodontitis and periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control with Periimplantitis group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Systemically healthy patients with periimplantitis will be included in this group. Patients will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Non-Surgical treatment</intervention_name>
    <description>Implant and teeth surfaces decontamination through scaling and planning, Curettage, profilaxys and Oral Hygiene orientation</description>
    <arm_group_label>Chronic Periodontitis with Periimplantitis group</arm_group_label>
    <arm_group_label>Control with Periimplantitis group</arm_group_label>
    <arm_group_label>Smokers with Periimplantitis group</arm_group_label>
    <arm_group_label>Type 2 Diabetes with Periimplantitis group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Surgical Treatment</intervention_name>
    <description>Anaesthesia, Incision, curettage, Treatment of the contaminated implant surface, Irrigation with saline, Guided Bone Regeneration and suture</description>
    <arm_group_label>Chronic Periodontitis with Periimplantitis group</arm_group_label>
    <arm_group_label>Control with Periimplantitis group</arm_group_label>
    <arm_group_label>Smokers with Periimplantitis group</arm_group_label>
    <arm_group_label>Type 2 Diabetes with Periimplantitis group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
        Implants diagnosed with peri-implantitis with boné defects; Probing depth ≥ 4mm; Positive&#xD;
        Bleeding on Probing and Suppuration score; Radiographic Bone Loss ≥ 3mm; Generalized&#xD;
        Chronic Periodontitis (Armitage, 1999); Heavy Smokers (&gt; 10 cigarets per day); Type 2&#xD;
        Diabetes Mellitus tipo 2 (ADA, 2005) with HbA1c between 6.5% and 7.5%&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        Complete Edentulism; Mucosal disease; Alcohol abuse; Systemic disease except type 2&#xD;
        Diabetes Mellitus, that might interfere in periimplantitis progression; Medication intake:&#xD;
        anticoagulants, antineoplasics, contraceptives, bisphosphonates and antidepressives;&#xD;
        Medication intake in the last 6 months: antibiotics; Medication intake in the last 3&#xD;
        months: antiinflammatories; Aggressive Periodontitis and Anaphylactic shock history;&#xD;
        Periodontal treatment in the last 6 months before the baseline; Periodontal Pockets &gt; 7mm;&#xD;
        Light Smokers (&lt; 10 cigarets/day); Implant Mobility.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_contact>
    <last_name>Luiz A Lima, phd</last_name>
    <phone>+5511992228876</phone>
    <email>lapalima@usp.br</email>
  </overall_contact>
  <location>
    <facility>
      <name>Faculdade de Odontologia Universidade de Sao Paulo</name>
      <address>
        <city>São Paulo</city>
        <state>Sao Paulo</state>
        <country>Brazil</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luiz Lima, PhD</last_name>
      <phone>+551130917418</phone>
      <email>lapalima@usp.br</email>
    </contact>
    <contact_backup>
      <last_name>Daniela Y Takahashi, MSc</last_name>
      <phone>+551130917833</phone>
      <email>danyumietk@usp.br</email>
    </contact_backup>
    <investigator>
      <last_name>Debora M Nomoto, DDS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Mauro A Murataka, DDS</last_name>
      <role>Sub-Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>March 2019</verification_date>
  <study_first_submitted>January 21, 2019</study_first_submitted>
  <study_first_submitted_qc>January 22, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 24, 2019</study_first_posted>
  <last_update_submitted>March 7, 2019</last_update_submitted>
  <last_update_submitted_qc>March 7, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of Sao Paulo</investigator_affiliation>
    <investigator_full_name>Luiz Antonio Pugliesi Alves de Lima</investigator_full_name>
    <investigator_title>Associate Professor</investigator_title>
  </responsible_party>
  <keyword>peri-implantitis</keyword>
  <keyword>inflammation</keyword>
  <keyword>Therapy</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</mesh_term>
    <mesh_term>Peri-Implantitis</mesh_term>
    <mesh_term>Diabetes Mellitus, Type 2</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</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/NCT03814434
org study id: RiskFactorsSurgPeriimplantitis
nct id: NCT03814434
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study evaluates clinical and radiographic parameters among riks factor groups in
      patients with periimplantitis. This study will also treat and evaluate the patients response
      before and after surgical treatment.
Periimplantitis (PI) is an inflammatory process that results in tissue attachment bone loss
      around the implant. Periodontal disease, smoke habit and type 2diabetes mellitus have been
      recognized as potential risk factor indicators that might lead to complications establishment
      and progression around dental implants. PI treatment predictability has been shown limited
      and influenced by factors not totally clarified. The aim of this study is to evaluate the
      reparative response after PI surgical treatment at clinical and radiographic levelsin risk
      factors patients: type 2 diabetes mellitus, smokers and chronic periodontal disease.
allocation: Non-Randomized
intervention model: Parallel Assignment
intervention model description: This is not a randomized study. All patients will entered the study after being diagnosed with periimplantitis. Patients will be allocated to different groups according to their condition: Heavy Smokers, Type 2 Diabetes Mellitus, Chronic periodontitis and systemically healthy patients (control group).
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
masking description: Surgeon will not be aware of group being treated. Analyses of the data and statistics will not show explain what group has originated the data. Groups will be identified as A, B, C or D.
measure: Radiographic Bone height Gain
time frame: 3 months
description: Radiographic Bone Height Gain Comparison to baseline 3 months after surgical treatment
measure: Periimplant Pocket probing depth
time frame: 3 months
description: Periimplant probing depth comparison to baseline 3 months after surgical treatment
arm group label: Smokers with Periimplantitis group
arm group type: Experimental
description: Heavy smokers patients with periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
arm group label: Type 2 Diabetes with Periimplantitis group
arm group type: Experimental
description: Patients diagnosed with Type 2 Diabetes with periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
arm group label: Chronic Periodontitis with Periimplantitis group
arm group type: Experimental
description: Patients diagnosed with Chronic Periodontitis and periimplantitis will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
arm group label: Control with Periimplantitis group
arm group type: Experimental
description: Systemically healthy patients with periimplantitis will be included in this group. Patients will be evaluated and will have their clinical, biological and radiographic data collected at baseline, after non-surgical and surgical treatment and after 3, 6 and 12 months.
intervention type: Procedure
intervention name: Non-Surgical treatment
description: Implant and teeth surfaces decontamination through scaling and planning, Curettage, profilaxys and Oral Hygiene orientation
arm group label: Chronic Periodontitis with Periimplantitis group
arm group label: Control with Periimplantitis group
arm group label: Smokers with Periimplantitis group
arm group label: Type 2 Diabetes with Periimplantitis group
intervention type: Procedure
intervention name: Surgical Treatment
description: Anaesthesia, Incision, curettage, Treatment of the contaminated implant surface, Irrigation with saline, Guided Bone Regeneration and suture
arm group label: Chronic Periodontitis with Periimplantitis group
arm group label: Control with Periimplantitis group
arm group label: Smokers with Periimplantitis group
arm group label: Type 2 Diabetes with Periimplantitis group
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Luiz A Lima, phd
phone: +5511992228876
email: lapalima@usp.br
facility: 
status: Recruiting
contact: 
contact backup: 
investigator: 
investigator: 
country: Brazil
responsible party type: Sponsor-Investigator
investigator affiliation: University of Sao Paulo
investigator full name: Luiz Antonio Pugliesi Alves de Lima
investigator title: Associate Professor
mesh term: Periodontal Diseases
mesh term: Peri-Implantitis
mesh term: Diabetes Mellitus, Type 2
sharing ipd: No