<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/NCT03797807</url>
  </required_header>
  <id_info>
    <org_study_id>18/LO/1956</org_study_id>
    <nct_id>NCT03797807</nct_id>
  </id_info>
  <brief_title>Minimally-invasive Non-surgical and Surgical Periodontitis Treatment</brief_title>
  <official_title>Clinical and Radiographic Changes in Intrabony Defects Following Non-surgical vs. Surgical Minimally-invasive Periodontal Therapy. A Parallel Group, Single Centre, Examiner-blind, Non-inferiority Randomised Controlled Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Queen Mary University of London</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Queen Mary University of London</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 compare the efficacy of a modified minimally-invasive non-surgical periodontal therapy&#xD;
      (MINST) approach with a surgical approach (M-MIST) in determining bone and clinical&#xD;
      attachment changes in intrabony defects&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Periodontal diseases are inflammatory conditions that affect the supporting apparatus of the&#xD;
      teeth, including gingiva and alveolar bone. The bone loss resulting from periodontitis often&#xD;
      is irregular and localised, giving onset to 'intrabony' or 'vertical defects' affecting one&#xD;
      side of the tooth more than the other and more than on the neighbouring teeth. Periodontal&#xD;
      intrabony defects have been associated with a higher risk of further progression and&#xD;
      eventually tooth loss.&#xD;
&#xD;
      The treatment of periodontitis involves a non-specific reduction of the bacterial load below&#xD;
      the gingival margin. This is achieved by oral hygiene instructions (OHI) and non-surgical&#xD;
      periodontal therapy (NSPT), aimed at removing calculus and disrupting the plaque biofilm from&#xD;
      the affected root surfaces. Intrabony defects are considered sites requiring therapy, often&#xD;
      beyond NSPT. Decades ago, intrabony defects were treated with surgical elimination of the&#xD;
      defect achieved by sacrificing the adjacent healthy supportive or non-supportive bone. More&#xD;
      recently periodontal regenerative procedures have been advocated for deep intrabony defects,&#xD;
      which are considered amenable for guided tissue regeneration. This technique results in&#xD;
      regeneration of periodontal attachment measurable histologically and radiographically and&#xD;
      measurable clinically. However, this is associated with potential morbidity and high costs&#xD;
      due to the use of bone graft and barrier materials and is not always predictable. The more&#xD;
      recent introduction of minimally-invasive surgical therapy (MIST), modified-MIST (M-MIST) and&#xD;
      single-flap approach suggested that the use of biomaterials may not be so crucial for&#xD;
      obtaining periodontal regeneration.&#xD;
&#xD;
      Retrospective studies from the investigator's group have shown that minimally invasive&#xD;
      non-surgical periodontal treatment of intrabony defects results in clinical improvements&#xD;
      (measured as PPD reductions and clinical attachment level-CAL- gain) but also in bone fill of&#xD;
      the bony defects, measurable radiographically. The extent of the radiographic resolution of&#xD;
      the defect was positively associated with initial defect depth and use of adjunctive&#xD;
      antibiotics, while smoking seemed to negatively influence this outcome. A non-surgical&#xD;
      minimally-invasive treatment protocol, named MINST, has been proposed along these principles.&#xD;
      A more recent retrospective analysis has revealed a reduction in bony defect of nearly 3 mm&#xD;
      for cases treated with minimally-invasive non-surgical therapy. The effect of MINST may be&#xD;
      mediated by improved blood flow and stable blood clot in the intrabony defect. However, very&#xD;
      few studies have been published on MINST and no data are available on the comparison between&#xD;
      MINST and MIST.&#xD;
&#xD;
      This is a parallel group, single centre, examiner-blind, non-inferiority randomized&#xD;
      controlled trial to compare the effect of a modified minimally-invasive non-surgical therapy&#xD;
      (MINST) approach to minimally invasive surgical treatment (MIST) in the healing of&#xD;
      periodontal intrabony defects in 66 patients with periodontitis .&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Recruiting</overall_status>
  <start_date type="Actual">March 20, 2019</start_date>
  <completion_date type="Anticipated">April 30, 2025</completion_date>
  <primary_completion_date type="Anticipated">April 30, 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>Radiographic whole defect depth change</measure>
    <time_frame>9 months</time_frame>
    <description>Radiographic whole defect depth change in millimeters at 9 months [considered a surrogate measure evaluating the entire regenerative process including bone, cementum and periodontal ligament</description>
  </primary_outcome>
  <other_outcome>
    <measure>Probing Pocket Depth (PPD) change</measure>
    <time_frame>Up to 15 months</time_frame>
    <description>Probing Pocket Depth (PPD) change (in mm)</description>
  </other_outcome>
  <other_outcome>
    <measure>Clinical Attachment Level (CAL) gain change</measure>
    <time_frame>Up to 15 months</time_frame>
    <description>Clinical Attachment Level (CAL) gain change (in mm)</description>
  </other_outcome>
  <other_outcome>
    <measure>Markers and growth factors in gingival crevicular fluid (GCF)</measure>
    <time_frame>Up to 15 months</time_frame>
    <description>Levels of inflammatory markers and growth factors in gingival crevicular fluid (GCF). Specifically, markers related with the healing of epithelium, connective tissue, bone and related to inflammatory/host responses will be examined.</description>
  </other_outcome>
  <other_outcome>
    <measure>Bacterial detection</measure>
    <time_frame>Up to 15 months</time_frame>
    <description>Bacterial detection associated with presence of intrabony defects</description>
  </other_outcome>
  <other_outcome>
    <measure>Gingival inflammation and healing</measure>
    <time_frame>Up to 15 months</time_frame>
    <description>Gingival inflammation and healing (as measured by geometric/thermal stereophotogrammetry imaging in the 'GTI sub-study')</description>
  </other_outcome>
  <other_outcome>
    <measure>Self administered OIDP (oral impact on daily performances index)</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>We will utilize the oral impact on daily performances index (OIDP) to evaluate health and treatment outcomes. The OIDP focuses on the impact that the conditions of the teeth and mouth have on the physical/functional, psychological and social well-being of the person. Particularly, it assesses the impact of oral conditions on basic daily life activities and behaviours (eating, speaking, cleaning teeth, and going out, relaxing, smiling, major work or role, emotional stability, social contact). For each performance, both the frequency and severity of oral impacts are assessed. The overall OIDP score ranges from 0 to 100, with higher scores indicating worse quality of life.</description>
  </other_outcome>
  <other_outcome>
    <measure>Global ratings on health and quality of life with Visual Analogue Scale (VAS)</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>The VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.</description>
  </other_outcome>
  <other_outcome>
    <measure>Global ratings on health and quality of life with a question &quot;How would you rate the quality of your life&quot;</measure>
    <time_frame>Up to 9 months</time_frame>
    <description>The responses will be scored on a six-point scale as:&#xD;
Excellent&#xD;
Very good&#xD;
Good&#xD;
Fair&#xD;
Poor&#xD;
Very poor</description>
  </other_outcome>
  <number_of_arms>4</number_of_arms>
  <enrollment type="Anticipated">66</enrollment>
  <condition>Periodontitis</condition>
  <arm_group>
    <arm_group_label>MINST</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Minimally invasive non surgical treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>MIST</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Minimally invasive surgical treatment</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GTI + MINST</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Minimally invasive non surgical treatment + Geometric/Thermal Imaging (GTI subgroup)</description>
  </arm_group>
  <arm_group>
    <arm_group_label>GTI + MIST</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Minimally invasive surgical treatment + Geometric/Thermal Imaging (GTI subgroup)</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MINST</intervention_name>
    <description>A non-surgical minimally invasive treatment protocol, named MINST, has been proposed for the treatment of periodontal intrabony defects, in order to minimize patient discomfort and maximize the healing potential</description>
    <arm_group_label>GTI + MINST</arm_group_label>
    <arm_group_label>MINST</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>MIST</intervention_name>
    <description>A minimally invasive surgical treatment protocol, named MIST, has been proposed for the treatment of periodontal intrabony defects, in order to minimize patient discomfort and maximize the healing potential</description>
    <arm_group_label>GTI + MIST</arm_group_label>
    <arm_group_label>MIST</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Diagnostic Test</intervention_type>
    <intervention_name>GTI subgroup (Geometrical/Thermal Imaging)</intervention_name>
    <description>Geometrical/Thermal Imaging</description>
    <arm_group_label>GTI + MINST</arm_group_label>
    <arm_group_label>GTI + MIST</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Age 25-70&#xD;
&#xD;
          2. Diagnosis of 'Periodontitis' stage III or IV (grades A to C)&#xD;
&#xD;
          3. Presence of ≥1 'intrabony defect' (PPD, &gt;5 mm with intrabony defect depth ≥3mm at&#xD;
             screening radiograph),&#xD;
&#xD;
          4. Signed informed consent. -&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
        1. Smoking (current or in past 5 years) including e-cigarettes/vaping 2. Medical history&#xD;
        including diabetes or hepatic or renal disease, or other serious medical conditions or&#xD;
        transmittable diseases 3. History of conditions requiring prophylactic antibiotic coverage&#xD;
        prior to invasive dental procedures 4. Antiinflammatory or anticoagulant therapy during the&#xD;
        month preceding the baseline exam 5. Systemic antibiotic therapy during the 3 months&#xD;
        preceding the baseline exam 6. History of alcohol or drug abuse, 7. Self-reported pregnancy&#xD;
        or lactation 8. Other severe acute or chronic medical or psychiatric condition or&#xD;
        laboratory abnormality that according to the investigator may increase the risk associated&#xD;
        with trial participation, 9. Periodontal treatment to the study site within the last 12&#xD;
        months (excluding not-extensive subgingival debridement as judged by the examining&#xD;
        clinician).&#xD;
&#xD;
        -&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Luigi Nibali, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>Barts &amp; The London School of Medicine &amp; Dentistry, QMUL</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Vandana Luthra, Dr.</last_name>
    <phone>02078826348</phone>
    <email>BHNT.Clinicaloralresearchcentre@nhs.net</email>
  </overall_contact>
  <location>
    <facility>
      <name>Barts and The London Dental Hospital</name>
      <address>
        <city>London</city>
        <zip>E1 2AD</zip>
        <country>United Kingdom</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Rinat Ezra, PhD</last_name>
      <phone>0207 882 6348</phone>
      <phone_ext>6348</phone_ext>
      <email>BHNT.Clinicaloralresearchcentre@nhs.net</email>
    </contact>
    <contact_backup>
      <last_name>Simona Salomone, PhD</last_name>
      <phone>0207 882 6064</phone>
      <phone_ext>6064</phone_ext>
      <email>BHNT.Clinicaloralresearchcentre@nhs.net</email>
    </contact_backup>
  </location>
  <location_countries>
    <country>United Kingdom</country>
  </location_countries>
  <reference>
    <citation>Papapanou PN, Tonetti MS. Diagnosis and epidemiology of periodontal osseous lesions. Periodontol 2000. 2000 Feb;22:8-21. doi: 10.1034/j.1600-0757.2000.2220102.x. No abstract available.</citation>
    <PMID>11276518</PMID>
  </reference>
  <reference>
    <citation>Papapanou PN, Wennstrom JL. The angular bony defect as indicator of further alveolar bone loss. J Clin Periodontol. 1991 May;18(5):317-22. doi: 10.1111/j.1600-051x.1991.tb00435.x.</citation>
    <PMID>2066446</PMID>
  </reference>
  <reference>
    <citation>Heitz-Mayfield LJ, Trombelli L, Heitz F, Needleman I, Moles D. A systematic review of the effect of surgical debridement vs non-surgical debridement for the treatment of chronic periodontitis. J Clin Periodontol. 2002;29 Suppl 3:92-102; discussion 160-2. doi: 10.1034/j.1600-051x.29.s3.5.x.</citation>
    <PMID>12787211</PMID>
  </reference>
  <reference>
    <citation>Nyman S, Lindhe J, Karring T, Rylander H. New attachment following surgical treatment of human periodontal disease. J Clin Periodontol. 1982 Jul;9(4):290-6. doi: 10.1111/j.1600-051x.1982.tb02095.x.</citation>
    <PMID>6964676</PMID>
  </reference>
  <reference>
    <citation>Cortellini P, Tonetti MS. Focus on intrabony defects: guided tissue regeneration. Periodontol 2000. 2000 Feb;22:104-32. doi: 10.1034/j.1600-0757.2000.2220108.x. No abstract available.</citation>
    <PMID>11276509</PMID>
  </reference>
  <reference>
    <citation>Needleman IG, Worthington HV, Giedrys-Leeper E, Tucker RJ. Guided tissue regeneration for periodontal infra-bony defects. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD001724. doi: 10.1002/14651858.CD001724.pub2.</citation>
    <PMID>16625546</PMID>
  </reference>
  <reference>
    <citation>Trombelli L, Farina R, Franceschetti G, Calura G. Single-flap approach with buccal access in periodontal reconstructive procedures. J Periodontol. 2009 Feb;80(2):353-60. doi: 10.1902/jop.2009.080420.</citation>
    <PMID>19186978</PMID>
  </reference>
  <reference>
    <citation>Cortellini P, Tonetti MS. Clinical and radiographic outcomes of the modified minimally invasive surgical technique with and without regenerative materials: a randomized-controlled trial in intra-bony defects. J Clin Periodontol. 2011 Apr;38(4):365-73. doi: 10.1111/j.1600-051X.2011.01705.x. Epub 2011 Feb 8.</citation>
    <PMID>21303402</PMID>
  </reference>
  <reference>
    <citation>Nibali L, Pometti D, Tu YK, Donos N. Clinical and radiographic outcomes following non-surgical therapy of periodontal infrabony defects: a retrospective study. J Clin Periodontol. 2011 Jan;38(1):50-7. doi: 10.1111/j.1600-051X.2010.01648.x. Epub 2010 Nov 22.</citation>
    <PMID>21091528</PMID>
  </reference>
  <reference>
    <citation>Ribeiro FV, Casarin RC, Palma MA, Junior FH, Sallum EA, Casati MZ. Clinical and patient-centered outcomes after minimally invasive non-surgical or surgical approaches for the treatment of intrabony defects: a randomized clinical trial. J Periodontol. 2011 Sep;82(9):1256-66. doi: 10.1902/jop.2011.100680. Epub 2011 Feb 2.</citation>
    <PMID>21284549</PMID>
  </reference>
  <reference>
    <citation>Nibali L, Pometti D, Chen TT, Tu YK. Minimally invasive non-surgical approach for the treatment of periodontal intrabony defects: a retrospective analysis. J Clin Periodontol. 2015 Sep;42(9):853-859. doi: 10.1111/jcpe.12443. Epub 2015 Sep 29.</citation>
    <PMID>26257238</PMID>
  </reference>
  <verification_date>May 2023</verification_date>
  <study_first_submitted>December 19, 2018</study_first_submitted>
  <study_first_submitted_qc>January 8, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 9, 2019</study_first_posted>
  <last_update_submitted>May 25, 2023</last_update_submitted>
  <last_update_submitted_qc>May 25, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">May 26, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</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/NCT03797807
org study id: 18/LO/1956
nct id: NCT03797807
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
To compare the efficacy of a modified minimally-invasive non-surgical periodontal therapy
      (MINST) approach with a surgical approach (M-MIST) in determining bone and clinical
      attachment changes in intrabony defects
Periodontal diseases are inflammatory conditions that affect the supporting apparatus of the
      teeth, including gingiva and alveolar bone. The bone loss resulting from periodontitis often
      is irregular and localised, giving onset to 'intrabony' or 'vertical defects' affecting one
      side of the tooth more than the other and more than on the neighbouring teeth. Periodontal
      intrabony defects have been associated with a higher risk of further progression and
      eventually tooth loss.

      The treatment of periodontitis involves a non-specific reduction of the bacterial load below
      the gingival margin. This is achieved by oral hygiene instructions (OHI) and non-surgical
      periodontal therapy (NSPT), aimed at removing calculus and disrupting the plaque biofilm from
      the affected root surfaces. Intrabony defects are considered sites requiring therapy, often
      beyond NSPT. Decades ago, intrabony defects were treated with surgical elimination of the
      defect achieved by sacrificing the adjacent healthy supportive or non-supportive bone. More
      recently periodontal regenerative procedures have been advocated for deep intrabony defects,
      which are considered amenable for guided tissue regeneration. This technique results in
      regeneration of periodontal attachment measurable histologically and radiographically and
      measurable clinically. However, this is associated with potential morbidity and high costs
      due to the use of bone graft and barrier materials and is not always predictable. The more
      recent introduction of minimally-invasive surgical therapy (MIST), modified-MIST (M-MIST) and
      single-flap approach suggested that the use of biomaterials may not be so crucial for
      obtaining periodontal regeneration.

      Retrospective studies from the investigator's group have shown that minimally invasive
      non-surgical periodontal treatment of intrabony defects results in clinical improvements
      (measured as PPD reductions and clinical attachment level-CAL- gain) but also in bone fill of
      the bony defects, measurable radiographically. The extent of the radiographic resolution of
      the defect was positively associated with initial defect depth and use of adjunctive
      antibiotics, while smoking seemed to negatively influence this outcome. A non-surgical
      minimally-invasive treatment protocol, named MINST, has been proposed along these principles.
      A more recent retrospective analysis has revealed a reduction in bony defect of nearly 3 mm
      for cases treated with minimally-invasive non-surgical therapy. The effect of MINST may be
      mediated by improved blood flow and stable blood clot in the intrabony defect. However, very
      few studies have been published on MINST and no data are available on the comparison between
      MINST and MIST.

      This is a parallel group, single centre, examiner-blind, non-inferiority randomized
      controlled trial to compare the effect of a modified minimally-invasive non-surgical therapy
      (MINST) approach to minimally invasive surgical treatment (MIST) in the healing of
      periodontal intrabony defects in 66 patients with periodontitis .
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Outcomes Assessor)
measure: Radiographic whole defect depth change
time frame: 9 months
description: Radiographic whole defect depth change in millimeters at 9 months [considered a surrogate measure evaluating the entire regenerative process including bone, cementum and periodontal ligament
measure: Probing Pocket Depth (PPD) change
time frame: Up to 15 months
description: Probing Pocket Depth (PPD) change (in mm)
measure: Clinical Attachment Level (CAL) gain change
time frame: Up to 15 months
description: Clinical Attachment Level (CAL) gain change (in mm)
measure: Markers and growth factors in gingival crevicular fluid (GCF)
time frame: Up to 15 months
description: Levels of inflammatory markers and growth factors in gingival crevicular fluid (GCF). Specifically, markers related with the healing of epithelium, connective tissue, bone and related to inflammatory/host responses will be examined.
measure: Bacterial detection
time frame: Up to 15 months
description: Bacterial detection associated with presence of intrabony defects
measure: Gingival inflammation and healing
time frame: Up to 15 months
description: Gingival inflammation and healing (as measured by geometric/thermal stereophotogrammetry imaging in the 'GTI sub-study')
measure: Self administered OIDP (oral impact on daily performances index)
time frame: Up to 9 months
description: We will utilize the oral impact on daily performances index (OIDP) to evaluate health and treatment outcomes. The OIDP focuses on the impact that the conditions of the teeth and mouth have on the physical/functional, psychological and social well-being of the person. Particularly, it assesses the impact of oral conditions on basic daily life activities and behaviours (eating, speaking, cleaning teeth, and going out, relaxing, smiling, major work or role, emotional stability, social contact). For each performance, both the frequency and severity of oral impacts are assessed. The overall OIDP score ranges from 0 to 100, with higher scores indicating worse quality of life.
measure: Global ratings on health and quality of life with Visual Analogue Scale (VAS)
time frame: Up to 9 months
description: The VAS records the patient's self-rated health on a vertical visual analogue scale, where the endpoints are labelled 'The best health you can imagine' and 'The worst health you can imagine'.
measure: Global ratings on health and quality of life with a question "How would you rate the quality of your life"
time frame: Up to 9 months
description: The responses will be scored on a six-point scale as:
Excellent
Very good
Good
Fair
Poor
Very poor
arm group label: MINST
arm group type: Experimental
description: Minimally invasive non surgical treatment
arm group label: MIST
arm group type: Active Comparator
description: Minimally invasive surgical treatment
arm group label: GTI + MINST
arm group type: Active Comparator
description: Minimally invasive non surgical treatment + Geometric/Thermal Imaging (GTI subgroup)
arm group label: GTI + MIST
arm group type: Active Comparator
description: Minimally invasive surgical treatment + Geometric/Thermal Imaging (GTI subgroup)
intervention type: Procedure
intervention name: MINST
description: A non-surgical minimally invasive treatment protocol, named MINST, has been proposed for the treatment of periodontal intrabony defects, in order to minimize patient discomfort and maximize the healing potential
arm group label: GTI + MINST
arm group label: MINST
intervention type: Procedure
intervention name: MIST
description: A minimally invasive surgical treatment protocol, named MIST, has been proposed for the treatment of periodontal intrabony defects, in order to minimize patient discomfort and maximize the healing potential
arm group label: GTI + MIST
arm group label: MIST
intervention type: Diagnostic Test
intervention name: GTI subgroup (Geometrical/Thermal Imaging)
description: Geometrical/Thermal Imaging
arm group label: GTI + MINST
arm group label: GTI + MIST
criteria: 
gender: All
minimum age: 25 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Luigi Nibali, PhD
role: Principal Investigator
affiliation: Barts & The London School of Medicine & Dentistry, QMUL
last name: Vandana Luthra, Dr.
phone: 02078826348
email: BHNT.Clinicaloralresearchcentre@nhs.net
facility: 
status: Recruiting
contact: 
contact backup: 
country: United Kingdom
citation: Papapanou PN, Tonetti MS. Diagnosis and epidemiology of periodontal osseous lesions. Periodontol 2000. 2000 Feb;22:8-21. doi: 10.1034/j.1600-0757.2000.2220102.x. No abstract available.
PMID: 11276518
citation: Papapanou PN, Wennstrom JL. The angular bony defect as indicator of further alveolar bone loss. J Clin Periodontol. 1991 May;18(5):317-22. doi: 10.1111/j.1600-051x.1991.tb00435.x.
PMID: 2066446
citation: Heitz-Mayfield LJ, Trombelli L, Heitz F, Needleman I, Moles D. A systematic review of the effect of surgical debridement vs non-surgical debridement for the treatment of chronic periodontitis. J Clin Periodontol. 2002;29 Suppl 3:92-102; discussion 160-2. doi: 10.1034/j.1600-051x.29.s3.5.x.
PMID: 12787211
citation: Nyman S, Lindhe J, Karring T, Rylander H. New attachment following surgical treatment of human periodontal disease. J Clin Periodontol. 1982 Jul;9(4):290-6. doi: 10.1111/j.1600-051x.1982.tb02095.x.
PMID: 6964676
citation: Cortellini P, Tonetti MS. Focus on intrabony defects: guided tissue regeneration. Periodontol 2000. 2000 Feb;22:104-32. doi: 10.1034/j.1600-0757.2000.2220108.x. No abstract available.
PMID: 11276509
citation: Needleman IG, Worthington HV, Giedrys-Leeper E, Tucker RJ. Guided tissue regeneration for periodontal infra-bony defects. Cochrane Database Syst Rev. 2006 Apr 19;(2):CD001724. doi: 10.1002/14651858.CD001724.pub2.
PMID: 16625546
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PMID: 21303402
citation: Nibali L, Pometti D, Tu YK, Donos N. Clinical and radiographic outcomes following non-surgical therapy of periodontal infrabony defects: a retrospective study. J Clin Periodontol. 2011 Jan;38(1):50-7. doi: 10.1111/j.1600-051X.2010.01648.x. Epub 2010 Nov 22.
PMID: 21091528
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citation: Nibali L, Pometti D, Chen TT, Tu YK. Minimally invasive non-surgical approach for the treatment of periodontal intrabony defects: a retrospective analysis. J Clin Periodontol. 2015 Sep;42(9):853-859. doi: 10.1111/jcpe.12443. Epub 2015 Sep 29.
PMID: 26257238
responsible party type: Sponsor
mesh term: Periodontitis
sharing ipd: No