<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/NCT03819075</url>
  </required_header>
  <id_info>
    <org_study_id>26/CE-IUCS/2018</org_study_id>
    <nct_id>NCT03819075</nct_id>
  </id_info>
  <brief_title>Combined Er:YAG And Nd:YAG Laser Protocol For Treatment Of Peri-Implantitis</brief_title>
  <official_title>An Evaluation Of Effectiveness Of A Combined Er:YAG And Nd:YAG Laser Protocol For Treatment Of Peri-Implantitis: A Randomized Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Luis Monteiro</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cooperativa de Ensino Superior, Politécnico e Universitário</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>
      A laser treatment for periimplantitis using two different wavelengths (Er:YAG and Nd:YAG)&#xD;
      will be compared to standard treatment in a randomized clinical trial.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The general aim of this study is to evaluate the clinical outcome of the treatment of&#xD;
      peri-implantitis using a combination of a Er:YAG and Nd:YAG laser protocol or using a&#xD;
      conventional mechanical treatment in patients with a diagnosis of peri-implantitis.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 3, 2018</start_date>
  <completion_date type="Anticipated">May 2024</completion_date>
  <primary_completion_date type="Anticipated">December 2023</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>Two groups; laser and control</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Single (Outcomes Assessor)</masking>
    <masking_description>Clinical measurements will be performed by an evaluator unaware of group assignment.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Proportion of participants with treatment success</measure>
    <time_frame>6 months</time_frame>
    <description>Treatment success defined as implant survival with the absence of peri-implant probing depths (PD) greater than 5 mm with concomitant bleeding/suppuration and absence of progression of peri-implant bone loss.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Plaque index</measure>
    <time_frame>1 month</time_frame>
    <description>(PI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plaque index</measure>
    <time_frame>3 months</time_frame>
    <description>(PI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plaque index</measure>
    <time_frame>6 months</time_frame>
    <description>(PI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Plaque index</measure>
    <time_frame>12 months</time_frame>
    <description>(PI)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding on probing</measure>
    <time_frame>1 month</time_frame>
    <description>(BOP) evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding on probing</measure>
    <time_frame>3 months</time_frame>
    <description>evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding on probing</measure>
    <time_frame>6 months</time_frame>
    <description>evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding on probing</measure>
    <time_frame>12 months</time_frame>
    <description>evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing depth</measure>
    <time_frame>1 month</time_frame>
    <description>measured from the mucosal margin to the bottom of the pocket.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing depth</measure>
    <time_frame>3 months</time_frame>
    <description>measured from the mucosal margin to the bottom of the pocket.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing depth</measure>
    <time_frame>6 months</time_frame>
    <description>measured from the mucosal margin to the bottom of the pocket.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing depth</measure>
    <time_frame>12 months</time_frame>
    <description>measured from the mucosal margin to the bottom of the pocket.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mucosal recession</measure>
    <time_frame>1 month</time_frame>
    <description>measured from the mucosal margin to the bottom of the pocket.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mucosal recession</measure>
    <time_frame>3 months</time_frame>
    <description>measured from the mucosal margin to the bottom of the pocket.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mucosal recession</measure>
    <time_frame>6 months</time_frame>
    <description>measured from the mucosal margin to the bottom of the pocket.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Mucosal recession</measure>
    <time_frame>12 months</time_frame>
    <description>measured from the mucosal margin to the bottom of the pocket.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment level gain</measure>
    <time_frame>1 month</time_frame>
    <description>Difference in clinical attachment level at baseline and follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment level gain</measure>
    <time_frame>3 months</time_frame>
    <description>Difference in clinical attachment level at baseline and follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment level gain</measure>
    <time_frame>6 months</time_frame>
    <description>Difference in clinical attachment level at baseline and follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Clinical attachment level gain</measure>
    <time_frame>12 months</time_frame>
    <description>Difference in clinical attachment level at baseline and follow up.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life questionnaire</measure>
    <time_frame>0 months</time_frame>
    <description>Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life questionnaire</measure>
    <time_frame>1 month</time_frame>
    <description>Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life questionnaire</measure>
    <time_frame>3 months</time_frame>
    <description>Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Quality of life questionnaire</measure>
    <time_frame>12 months</time_frame>
    <description>Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">62</enrollment>
  <condition>Peri-Implantitis</condition>
  <arm_group>
    <arm_group_label>Laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>For the laser group we will use a Lightwalker Laser (Fotona) with a Er:YAG 2940 nm and Nd:YAG 1064 nm wavelengths units.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Standard periimplantitis treatment will be conducted in the control group.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Lightwalker Laser (Fotona)</intervention_name>
    <description>For the laser group we will use a Lightwalker Laser (Fotona) with a Er:YAG 2940 nm and Nd:YAG 1064 nm wavelengths units. The laser protocol will follow the instructions of the manufacturer (TwinLight protocol) and consists of degranulation of necrotic soft tissue and bone, implant surface disinfection and creating spot bleeding in bone with Er:YAG and deep disinfection and biomodulation with Nd:YAG.</description>
    <arm_group_label>Laser</arm_group_label>
    <other_name>TwinLight periimplantitis</other_name>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>standard</intervention_name>
    <description>Granulation tissue elimination, mechanical instrumentation of the implant surface and curettage of intraosseous or supracrestally bone defects will be accomplished using plastic curets, under irrigation with sterile saline solution. Cotton pellets soaked in sterile saline solution will be use to clean debris and remains of removed tissue.</description>
    <arm_group_label>Control</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least one implant with peri-implantitis&#xD;
&#xD;
          -  no serious mobility of the implants&#xD;
&#xD;
          -  written informed consent of the voluntary participant in the study&#xD;
&#xD;
          -  availability of participant for control visits for a follow-up of at least 12 months&#xD;
             without interruptions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  serious systematic disease&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  current use of photosensitive drugs, bisphosphonate medication or antibiotics&#xD;
&#xD;
          -  patients who do not want to follow post treatment recommendation of oral hygiene and&#xD;
             follow-up visits&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>No</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luis Monteiro, DMD, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Instituto Universitário de Ciências da Saude, CESPU</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Luis Monteiro, DMD, PhD</last_name>
    <phone>+351 919120226</phone>
    <email>luis.monteiro@iucs.cespu.pt</email>
  </overall_contact>
  <location>
    <facility>
      <name>Instituto Universitário de Ciências da Saude, CESPU</name>
      <address>
        <city>Porto</city>
        <zip>4585-116</zip>
        <country>Portugal</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Luis Monteiro</last_name>
      <phone>+351 919120226</phone>
      <email>luis.monteiro@iucs.cespu.pt</email>
    </contact>
  </location>
  <location_countries>
    <country>Portugal</country>
  </location_countries>
  <verification_date>August 2023</verification_date>
  <study_first_submitted>January 25, 2019</study_first_submitted>
  <study_first_submitted_qc>January 25, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 28, 2019</study_first_posted>
  <last_update_submitted>August 31, 2023</last_update_submitted>
  <last_update_submitted_qc>August 31, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">September 1, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cooperativa de Ensino Superior, Politécnico e Universitário</investigator_affiliation>
    <investigator_full_name>Luis Monteiro</investigator_full_name>
    <investigator_title>DMD, Phd, Auxiliar Professor at the IUCS in Periodontal Surgical Clinic, Oral Pathology and Biopathology</investigator_title>
  </responsible_party>
  <keyword>laser</keyword>
  <keyword>Er:YAG</keyword>
  <keyword>Nd:YAG</keyword>
  <keyword>periimplantitis</keyword>
  <keyword>randomized controlled trial</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Peri-Implantitis</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/NCT03819075
org study id: 26/CE-IUCS/2018
nct id: NCT03819075
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
A laser treatment for periimplantitis using two different wavelengths (Er:YAG and Nd:YAG)
      will be compared to standard treatment in a randomized clinical trial.
The general aim of this study is to evaluate the clinical outcome of the treatment of
      peri-implantitis using a combination of a Er:YAG and Nd:YAG laser protocol or using a
      conventional mechanical treatment in patients with a diagnosis of peri-implantitis.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Two groups; laser and control
primary purpose: Treatment
masking: Single (Outcomes Assessor)
masking description: Clinical measurements will be performed by an evaluator unaware of group assignment.
measure: Proportion of participants with treatment success
time frame: 6 months
description: Treatment success defined as implant survival with the absence of peri-implant probing depths (PD) greater than 5 mm with concomitant bleeding/suppuration and absence of progression of peri-implant bone loss.
measure: Plaque index
time frame: 1 month
description: (PI)
measure: Plaque index
time frame: 3 months
description: (PI)
measure: Plaque index
time frame: 6 months
description: (PI)
measure: Plaque index
time frame: 12 months
description: (PI)
measure: Bleeding on probing
time frame: 1 month
description: (BOP) evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.
measure: Bleeding on probing
time frame: 3 months
description: evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.
measure: Bleeding on probing
time frame: 6 months
description: evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.
measure: Bleeding on probing
time frame: 12 months
description: evaluated as present if bleeding was evident within 30 s after probing, or absent, if no bleeding was noticed within 30 s after probing.
measure: Probing depth
time frame: 1 month
description: measured from the mucosal margin to the bottom of the pocket.
measure: Probing depth
time frame: 3 months
description: measured from the mucosal margin to the bottom of the pocket.
measure: Probing depth
time frame: 6 months
description: measured from the mucosal margin to the bottom of the pocket.
measure: Probing depth
time frame: 12 months
description: measured from the mucosal margin to the bottom of the pocket.
measure: Mucosal recession
time frame: 1 month
description: measured from the mucosal margin to the bottom of the pocket.
measure: Mucosal recession
time frame: 3 months
description: measured from the mucosal margin to the bottom of the pocket.
measure: Mucosal recession
time frame: 6 months
description: measured from the mucosal margin to the bottom of the pocket.
measure: Mucosal recession
time frame: 12 months
description: measured from the mucosal margin to the bottom of the pocket.
measure: Clinical attachment level gain
time frame: 1 month
description: Difference in clinical attachment level at baseline and follow up.
measure: Clinical attachment level gain
time frame: 3 months
description: Difference in clinical attachment level at baseline and follow up.
measure: Clinical attachment level gain
time frame: 6 months
description: Difference in clinical attachment level at baseline and follow up.
measure: Clinical attachment level gain
time frame: 12 months
description: Difference in clinical attachment level at baseline and follow up.
measure: Quality of life questionnaire
time frame: 0 months
description: Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.
measure: Quality of life questionnaire
time frame: 1 month
description: Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.
measure: Quality of life questionnaire
time frame: 3 months
description: Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.
measure: Quality of life questionnaire
time frame: 6 months
description: Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.
measure: Quality of life questionnaire
time frame: 12 months
description: Oral Health Impact Profile-14 on the scale from 0 to 56 with higher scores indicating a poorer oral health-related quality of life.
arm group label: Laser
arm group type: Experimental
description: For the laser group we will use a Lightwalker Laser (Fotona) with a Er:YAG 2940 nm and Nd:YAG 1064 nm wavelengths units.
arm group label: Control
arm group type: Active Comparator
description: Standard periimplantitis treatment will be conducted in the control group.
intervention type: Device
intervention name: Lightwalker Laser (Fotona)
description: For the laser group we will use a Lightwalker Laser (Fotona) with a Er:YAG 2940 nm and Nd:YAG 1064 nm wavelengths units. The laser protocol will follow the instructions of the manufacturer (TwinLight protocol) and consists of degranulation of necrotic soft tissue and bone, implant surface disinfection and creating spot bleeding in bone with Er:YAG and deep disinfection and biomodulation with Nd:YAG.
arm group label: Laser
other name: TwinLight periimplantitis
intervention type: Other
intervention name: standard
description: Granulation tissue elimination, mechanical instrumentation of the implant surface and curettage of intraosseous or supracrestally bone defects will be accomplished using plastic curets, under irrigation with sterile saline solution. Cotton pellets soaked in sterile saline solution will be use to clean debris and remains of removed tissue.
arm group label: Control
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: No
last name: Luis Monteiro, DMD, PhD
role: Principal Investigator
affiliation: Instituto Universitário de Ciências da Saude, CESPU
last name: Luis Monteiro, DMD, PhD
phone: +351 919120226
email: luis.monteiro@iucs.cespu.pt
facility: 
status: Recruiting
contact: 
country: Portugal
responsible party type: Sponsor-Investigator
investigator affiliation: Cooperativa de Ensino Superior, Politécnico e Universitário
investigator full name: Luis Monteiro
investigator title: DMD, Phd, Auxiliar Professor at the IUCS in Periodontal Surgical Clinic, Oral Pathology and Biopathology
mesh term: Peri-Implantitis
sharing ipd: No