<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/NCT04440241</url>
  </required_header>
  <id_info>
    <org_study_id>REGT_CT_19</org_study_id>
    <nct_id>NCT04440241</nct_id>
  </id_info>
  <brief_title>Regenerative Surgical Treatment of Peri-implant Defects</brief_title>
  <official_title>Regenerative Surgical Treatment of Peri-implant Defects. Submerged Versus Not Submerged</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Santiago de Compostela</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Osteology Foundation</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Santiago de Compostela</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>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      Does submerged healing of implants improve clinical and radiologic outcomes for the treatment&#xD;
      of peri-implantitis? A number of recent systematic reviews have shown that the prevalence of&#xD;
      periimplantitisin the population is high.&#xD;
&#xD;
      Nevertheless, there appears to be no consensus on treatment standards for the management of&#xD;
      peri-implant diseases. Also, the significant variation in the empirical use of the available&#xD;
      therapeutic modalities seems to result in moderately effective treatment outcomes. Animal and&#xD;
      human case series-studies have shown improved outcomes when using a submerged healing&#xD;
      approach. However, there seems to be no randomized controlled clinical studies comparing&#xD;
      submerged/non-submerged healing efficacy for the treatment of peri-implantitis. Since current&#xD;
      modalities for the treatment of peri-implantitis seem to result inmoderately effective&#xD;
      outcomes, there is an urgency to investigate treatment strategies that will result in&#xD;
      improved patient's benefits in terms of health.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The present study will be double-blinded randomized controlled clinical trial. Patients&#xD;
      requiring surgical treatment of peri-implantitis after non-surgical therapy will beassigned&#xD;
      to either:&#xD;
&#xD;
      Test group: submerged healing or Control group: non-submerged healing treatment of&#xD;
      peri-implantitis using guided bone regeneration with a bone substitute and a resorbable&#xD;
      membrane.&#xD;
&#xD;
      The primary aim of this study is to evaluate whether submerged healing of implants&#xD;
      willsignificantly improve the changes in marginal bone levels measured on X-rays 12months&#xD;
      post-treatment compared to a non-submerged healing approach for the treatment of&#xD;
      peri-implantitis.&#xD;
&#xD;
      Secondary aims include changes in clinical attachment levels, changes in probing pocket&#xD;
      depth, recession, keratinized tissue, occurrence of bleeding on probing, suppuration on&#xD;
      probing (PUS), marginal gingival recession (REC), full mouth plaque score (FMPS), full mouth&#xD;
      bleeding score (FMBS), type of peri-implant bone defect, frequency and type of complications&#xD;
      and implant loss.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">April 1, 2021</start_date>
  <completion_date type="Anticipated">December 1, 2022</completion_date>
  <primary_completion_date type="Anticipated">December 1, 2021</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>Test group: submerged healing Control group: non-submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Changes marginal bone level</measure>
    <time_frame>baseline, 6 and 12 months</time_frame>
    <description>measured on periapical X-rays, from the shoulder of the implant to the bottom of the bone defect next to the implant at the mesial and distal surfaces. Mean marginal bone levels between mesial and distal measurements will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Changes Probing pocket depth</measure>
    <time_frame>baseline, 6 and 12 months</time_frame>
    <description>distance from the margin gingival to the bottom of the peri-implant pouch. All clinical variables will be recorded with a Hu-friedy CP15 UNC millimeter probe in six points on each implant.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Changes Clinical attachment level</measure>
    <time_frame>baseline, 6 and 12 months</time_frame>
    <description>Distance from the implant shoulder or prosthetic abutment to the bottom of the peri-implant pocket.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Reccesion</measure>
    <time_frame>baseline, 6 and 12 months</time_frame>
    <description>distance from the margin of the peri-implant mucosa to the implant / abutment interface.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change Keratinized mucosa</measure>
    <time_frame>baseline, 6 and 12 months</time_frame>
    <description>distance from the gingival margin up to the mucogingival line.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change blending on probing</measure>
    <time_frame>baseline, 6 and 12 months</time_frame>
    <description>Registry of presence of bleeding by binary scale (1 bleed present / 0 bleed absent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change supuration</measure>
    <time_frame>baseline, 6 and 12 months</time_frame>
    <description>Pus presence register by scale binary (1 present / 0 absent)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Change plaque score</measure>
    <time_frame>baseline, 6 and 12 months</time_frame>
    <description>Registration of presence of plaque by binary scale on each surface (1 present / 0 absent), calculating the percentage of total surfaces in which plaque is detected by using a periodontal probe</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>configuration of the bone defect</measure>
    <time_frame>baseline</time_frame>
    <description>Based on the classification of Schwarz et al. (2007)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">44</enrollment>
  <condition>Implant Site Pocket Infection</condition>
  <arm_group>
    <arm_group_label>Test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>non submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>regenerative treatment periimplantitis</intervention_name>
    <description>Full thickness buccal and lingual flaps will be performed. After debridement of the defect using hand and ultrasonic instruments and implant surface decontamination using titanium brushes (TiBrush®) and saline Regenerative treatment will be performed only in the intrabony component of type 1 peri-implant defects. Guided bone regeneration using a bone substitute (Bio-oss®) and a resorbable membrane (bio-gide®) will be performed in the intrabony and dehiscenses areas of the defect.&#xD;
The surgeon will be blinded to the assignment of treatment until it is time to close the flaps.</description>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_label>Test group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Age ≥18 years.&#xD;
&#xD;
          -  Systemically healthy patients.&#xD;
&#xD;
          -  Presence of at least 1 implant diagnosed with peri-implantitis (peri-implant probing&#xD;
             pocket depth ≥6 mm in at least 1 aspect of the implant with bleeding and/or&#xD;
             suppuration on probing and radiographically documented marginal bone loss ≥3mm)&#xD;
             according to Renvert et al. (2018), after non-surgical therapy of periimplantitis, and&#xD;
             a 4mm deep intrabony component.&#xD;
&#xD;
          -  Absence of mobility of the implants.&#xD;
&#xD;
          -  Individual implant-supported crown or partial fixed implant supported restoration&#xD;
             (removable prosthesis will be excluded).&#xD;
&#xD;
          -  Patient's smoking ≤ 10 cigarettes/day.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Non-removable prostheses&#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>Santiago Mareque</last_name>
    <role>Study Director</role>
    <affiliation>University of Santiago de Compostela</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Santiago Mareque</last_name>
    <phone>616 975 256‬</phone>
    <email>smareque@gmail.com</email>
  </overall_contact>
  <overall_contact_backup>
    <last_name>Juan Blanco</last_name>
    <phone>616 975 256‬</phone>
    <email>smareque@gmail.com</email>
  </overall_contact_backup>
  <location>
    <facility>
      <name>Master Periodoncia. Facultad odontología</name>
      <address>
        <city>Santiago De Compostela</city>
        <state>A Coruña</state>
        <zip>15782</zip>
        <country>Spain</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Santiago Mareque</last_name>
      <email>smareque@gmail.com</email>
    </contact>
    <contact_backup>
      <last_name>Carlota Blanco</last_name>
      <email>carlota.blanco@rai.usc.es</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
  <results_reference>
    <citation>Schwarz F, Herten M, Sager M, Bieling K, Sculean A, Becker J. Comparison of naturally occurring and ligature-induced peri-implantitis bone defects in humans and dogs. Clin Oral Implants Res. 2007 Apr;18(2):161-70. doi: 10.1111/j.1600-0501.2006.01320.x. Erratum In: Clin Oral Implants Res. 2007 Jun;18(3):397.</citation>
    <PMID>17348880</PMID>
  </results_reference>
  <results_reference>
    <citation>Schwarz F, Sahm N, Schwarz K, Becker J. Impact of defect configuration on the clinical outcome following surgical regenerative therapy of peri-implantitis. J Clin Periodontol. 2010 May;37(5):449-55. doi: 10.1111/j.1600-051X.2010.01540.x. Epub 2010 Mar 24.</citation>
    <PMID>20374416</PMID>
  </results_reference>
  <results_reference>
    <citation>Roccuzzo M, Bonino F, Bonino L, Dalmasso P. Surgical therapy of peri-implantitis lesions by means of a bovine-derived xenograft: comparative results of a prospective study on two different implant surfaces. J Clin Periodontol. 2011 Aug;38(8):738-45. doi: 10.1111/j.1600-051X.2011.01742.x. Epub 2011 Jun 2.</citation>
    <PMID>21635278</PMID>
  </results_reference>
  <verification_date>September 2021</verification_date>
  <study_first_submitted>June 15, 2020</study_first_submitted>
  <study_first_submitted_qc>June 18, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 19, 2020</study_first_posted>
  <last_update_submitted>September 28, 2021</last_update_submitted>
  <last_update_submitted_qc>September 28, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">September 29, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Santiago de Compostela</investigator_affiliation>
    <investigator_full_name>Juan Blanco Carrión</investigator_full_name>
    <investigator_title>Principal investigator - Juan Blanco Carrión</investigator_title>
  </responsible_party>
  <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/NCT04440241
org study id: REGT_CT_19
nct id: NCT04440241
lead sponsor: 
collaborator: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
is us export: No
Does submerged healing of implants improve clinical and radiologic outcomes for the treatment
      of peri-implantitis? A number of recent systematic reviews have shown that the prevalence of
      periimplantitisin the population is high.

      Nevertheless, there appears to be no consensus on treatment standards for the management of
      peri-implant diseases. Also, the significant variation in the empirical use of the available
      therapeutic modalities seems to result in moderately effective treatment outcomes. Animal and
      human case series-studies have shown improved outcomes when using a submerged healing
      approach. However, there seems to be no randomized controlled clinical studies comparing
      submerged/non-submerged healing efficacy for the treatment of peri-implantitis. Since current
      modalities for the treatment of peri-implantitis seem to result inmoderately effective
      outcomes, there is an urgency to investigate treatment strategies that will result in
      improved patient's benefits in terms of health.
The present study will be double-blinded randomized controlled clinical trial. Patients
      requiring surgical treatment of peri-implantitis after non-surgical therapy will beassigned
      to either:

      Test group: submerged healing or Control group: non-submerged healing treatment of
      peri-implantitis using guided bone regeneration with a bone substitute and a resorbable
      membrane.

      The primary aim of this study is to evaluate whether submerged healing of implants
      willsignificantly improve the changes in marginal bone levels measured on X-rays 12months
      post-treatment compared to a non-submerged healing approach for the treatment of
      peri-implantitis.

      Secondary aims include changes in clinical attachment levels, changes in probing pocket
      depth, recession, keratinized tissue, occurrence of bleeding on probing, suppuration on
      probing (PUS), marginal gingival recession (REC), full mouth plaque score (FMPS), full mouth
      bleeding score (FMBS), type of peri-implant bone defect, frequency and type of complications
      and implant loss.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Test group: submerged healing Control group: non-submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.
primary purpose: Treatment
masking: Double (Investigator, Outcomes Assessor)
measure: Changes marginal bone level
time frame: baseline, 6 and 12 months
description: measured on periapical X-rays, from the shoulder of the implant to the bottom of the bone defect next to the implant at the mesial and distal surfaces. Mean marginal bone levels between mesial and distal measurements will be calculated.
measure: Changes Probing pocket depth
time frame: baseline, 6 and 12 months
description: distance from the margin gingival to the bottom of the peri-implant pouch. All clinical variables will be recorded with a Hu-friedy CP15 UNC millimeter probe in six points on each implant.
measure: Changes Clinical attachment level
time frame: baseline, 6 and 12 months
description: Distance from the implant shoulder or prosthetic abutment to the bottom of the peri-implant pocket.
measure: Change Reccesion
time frame: baseline, 6 and 12 months
description: distance from the margin of the peri-implant mucosa to the implant / abutment interface.
measure: Change Keratinized mucosa
time frame: baseline, 6 and 12 months
description: distance from the gingival margin up to the mucogingival line.
measure: Change blending on probing
time frame: baseline, 6 and 12 months
description: Registry of presence of bleeding by binary scale (1 bleed present / 0 bleed absent)
measure: Change supuration
time frame: baseline, 6 and 12 months
description: Pus presence register by scale binary (1 present / 0 absent)
measure: Change plaque score
time frame: baseline, 6 and 12 months
description: Registration of presence of plaque by binary scale on each surface (1 present / 0 absent), calculating the percentage of total surfaces in which plaque is detected by using a periodontal probe
measure: configuration of the bone defect
time frame: baseline
description: Based on the classification of Schwarz et al. (2007)
arm group label: Test group
arm group type: Experimental
description: submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.
arm group label: Control group
arm group type: Experimental
description: non submerged healing treatment of peri-implantitis using guided bone regeneration with a bone substitute and a resorbable membrane.
intervention type: Procedure
intervention name: regenerative treatment periimplantitis
description: Full thickness buccal and lingual flaps will be performed. After debridement of the defect using hand and ultrasonic instruments and implant surface decontamination using titanium brushes (TiBrush®) and saline Regenerative treatment will be performed only in the intrabony component of type 1 peri-implant defects. Guided bone regeneration using a bone substitute (Bio-oss®) and a resorbable membrane (bio-gide®) will be performed in the intrabony and dehiscenses areas of the defect.
The surgeon will be blinded to the assignment of treatment until it is time to close the flaps.
arm group label: Control group
arm group label: Test group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Santiago Mareque
role: Study Director
affiliation: University of Santiago de Compostela
last name: Santiago Mareque
phone: 616 975 256‬
email: smareque@gmail.com
last name: Juan Blanco
phone: 616 975 256‬
email: smareque@gmail.com
facility: 
status: Recruiting
contact: 
contact backup: 
country: Spain
citation: Schwarz F, Herten M, Sager M, Bieling K, Sculean A, Becker J. Comparison of naturally occurring and ligature-induced peri-implantitis bone defects in humans and dogs. Clin Oral Implants Res. 2007 Apr;18(2):161-70. doi: 10.1111/j.1600-0501.2006.01320.x. Erratum In: Clin Oral Implants Res. 2007 Jun;18(3):397.
PMID: 17348880
citation: Schwarz F, Sahm N, Schwarz K, Becker J. Impact of defect configuration on the clinical outcome following surgical regenerative therapy of peri-implantitis. J Clin Periodontol. 2010 May;37(5):449-55. doi: 10.1111/j.1600-051X.2010.01540.x. Epub 2010 Mar 24.
PMID: 20374416
citation: Roccuzzo M, Bonino F, Bonino L, Dalmasso P. Surgical therapy of peri-implantitis lesions by means of a bovine-derived xenograft: comparative results of a prospective study on two different implant surfaces. J Clin Periodontol. 2011 Aug;38(8):738-45. doi: 10.1111/j.1600-051X.2011.01742.x. Epub 2011 Jun 2.
PMID: 21635278
responsible party type: Principal Investigator
investigator affiliation: University of Santiago de Compostela
investigator full name: Juan Blanco Carrión
investigator title: Principal investigator - Juan Blanco Carrión
sharing ipd: No