<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/NCT03258996</url>
  </required_header>
  <id_info>
    <org_study_id>2017_01</org_study_id>
    <nct_id>NCT03258996</nct_id>
  </id_info>
  <brief_title>m-VISTA Technique vs. CAF in the Treatment of Class III Multiple Recessions</brief_title>
  <official_title>Modified VISTA Technique Versus Coronally Advanced Flap in the Treatment of Class III Multiple Recessions: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Aitziber Fernandez Jimenez</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of the Basque Country (UPV/EHU)</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>
  </oversight_info>
  <brief_summary>
    <textblock>
      The main objective is to assess whether the percentage of root coverage (%RC) achieved in the&#xD;
      treatment of multiples class III recessions using the technique we have called modified&#xD;
      vestibular incision subperiosteal tunnel access (m-VISTA), which is a lateral approach&#xD;
      subperiosteal tunnel technique, combined with a connective tissue graft is greater than that&#xD;
      achieved through the coronally advance flap (CAF) technique together with a connective tissue&#xD;
      graft.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The reason for designing this study is that treatment of Class III gingival recessions&#xD;
      (Miller 1985) continues to be challenging today and, although different techniques have been&#xD;
      proposed to attempt to improve root coverage results, there is little evidence on what would&#xD;
      offer better results.&#xD;
&#xD;
      To achieve those objectives a randomized controlled clinical trial is designed. Using the&#xD;
      percentage of root coverage as a primary response variable, it is estimated with the&#xD;
      calculation of the sample size, we would need 11 patients for each treatment group (Domenech&#xD;
      and Granero 2010). In addition, taking into account possible drop-outs, we would increase the&#xD;
      number of patients by recruiting a total of 24 patients.&#xD;
&#xD;
      A same experienced, blind and calibrated (the intraclass correlation coefficient will be at&#xD;
      least of 0.75) examiner (R.E.) will collect the following periodontal clinical parameters at&#xD;
      the baseline, and at 6 and 12 months, in each tooth involved, using a periodontal probe:&#xD;
      Gingival recession, number and location of recessions to be treated, number of treated&#xD;
      recessions that have a complete root coverage, the width of the gingival recession and the&#xD;
      keratinized gingiva, the distance from the contact point to the interdental papilla, depth of&#xD;
      probing, bleeding index and plaque index. And will also collect the opinion of the&#xD;
      participant regarding pain and the degree of satisfaction with the aesthetic result.&#xD;
&#xD;
      Students of the University of the Basque Country's (UPV/EHU) Own Degree in Periodontology and&#xD;
      Osteointegration will perform the corresponding surgical technique (m-VISTA or CAF) depending&#xD;
      on the randomization sequence obtained. A clinical monitor (A.M.G.) will keep the sequence&#xD;
      hidden until the moment of the intervention.&#xD;
&#xD;
      Initially, the subject will not know which technique to receive, the complete information&#xD;
      regarding the surgical technique used, as the results obtained in his case, will be given in&#xD;
      the last visit of the year.&#xD;
&#xD;
      Finally, a blind statistic (X.M) will analyze the data using the SPSS software, having as&#xD;
      unit of analysis the subject. Doing a descriptive statistics, checking if the groups are&#xD;
      homogeneous in basal, inter-group, intra-group and change variables comparisons and&#xD;
      logistical regression to assess the intensity and duration of post-surgical pain adjusted for&#xD;
      possible confounding factors.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">December 4, 2017</start_date>
  <completion_date type="Actual">September 30, 2021</completion_date>
  <primary_completion_date type="Actual">March 31, 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>We will perform the experimental or control technique according to the randomization sequence.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
    <masking_description>Participant: Initially, the subject will not know what technique has been received, the complete information regarding the surgical technique used, as the results obtained in his case, will be given in the last visit of the year.&#xD;
Observer: Another periodoncist (R.E.), outside the intervention, would be in charge of recording the clinical parameters.&#xD;
Analyst: The statistician (X.M.) does not know which treatment corresponds to each variable.</masking_description>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of root coverage (%CR)</measure>
    <time_frame>12 months</time_frame>
    <description>In each patient the mean of their gingival recessions at baseline (initial RECm) and at 12 months (RECm_12 months) will be calculated. A new variable called %CR [(RECm_initial - RECm_12 months) / (RECm_initial x 100) will be calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Percentage of recessions with complete root coverage (%CRC)</measure>
    <time_frame>12 months</time_frame>
    <description>Each patient will record the number of recessions, which after treatment, show complete root coverage at 12 months (CRC_12 months). A new variable called % CRC_12 months [CRC_12meses / NRT x100] will be calculated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-surgical pain perception</measure>
    <time_frame>After surgery up to 14 days</time_frame>
    <description>The subject will we instructed to collect their perception of post-surgical pain in the VAS based Journal of Pain (IDT). Specifically the subject will record: Its intensity (0-100mm), its duration (minutes or hours) and if any analgesic treatment has been necessary (No o Yes: Which?).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival recession (REC)</measure>
    <time_frame>Change from baseline at following surgery sixth and twelfth month respectively.</time_frame>
    <description>Distance in mm from the amelocementaria line the gingival margin, measured at the vestibular midpoint. It will be registered in all the teeth present (except wisdom teeth) at the beginning, and, during the follow-up only in the recessions to be treated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-surgical aesthetic result (VAS aesthetic)</measure>
    <time_frame>12 months</time_frame>
    <description>The same examiner will evaluate the degree of satisfaction of the subject with the aesthetic result obtained after the intervention, through a Questionnaire based on the Visual Analogue Scale (VAS).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pre-surgical pain perception</measure>
    <time_frame>Baseline.</time_frame>
    <description>In the VAS based Journal of Pain (IDT) the examiner will record if the subject has had regional head and neck pain in the last month and if there is any pain in the immediate preoperative, if it is affirmative the intensity will be noted.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-surgical complications</measure>
    <time_frame>After surgery first seven days.</time_frame>
    <description>The presence or not, as the description, of the post-surgical complications (PSC) that may appear will be collected.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Central Sensitization Inventory severity-level score of the subject</measure>
    <time_frame>Baseline.</time_frame>
    <description>Central Sensitization inventory (CSI) (Mayer et al. 2012) will be done, in which each subject will be asked on the frequency in which he perceives 25 symptoms and will be given a score of 0-4 finally establishing a clinical level in a range of 0-100 points (Subclinical: 0-29; Medium: 30-39; Moderate: 40-49 ; Severe: 50-59; Extreme: 60-100).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of recessions to be treated (NRT) Number of recessions to be treated (NRT)</measure>
    <time_frame>Baseline.</time_frame>
    <description>Number of Class III recessions to be treated will be recorded.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Localization of the recessions to treat (LRT)</measure>
    <time_frame>Baseline.</time_frame>
    <description>On the one hand, upper recessions will be considered the located in the maxillary and on the other hand, lower recessions those located in the mandible.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Gingival recession width (GRW)</measure>
    <time_frame>Change from baseline at following surgery sixth and twelfth month respectively.</time_frame>
    <description>Mesio-distal distance taken in the coronal area of the same, measured in millimeters. It will be recorded only in the recessions to be treated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Keratinized gingiva width (KGW)</measure>
    <time_frame>Change from baseline at following surgery sixth and twelfth month respectively.</time_frame>
    <description>Distance in millimeters from the mucogingival junction to the gingival margin, measured at the vestibular midpoint. It will be recorded only in the recessions to be treated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Distance from contact point to the interdental papilla (CP-IP)</measure>
    <time_frame>Change from baseline at following surgery sixth and twelfth month respectively.</time_frame>
    <description>Distance in millimeters from the mesial and distal contact point of the tooth with recession, to the most coronal part of the interdental papilla. It will be recorded only in the recessions to be treated.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Probing depth (PD)</measure>
    <time_frame>Change from baseline at following surgery sixth and twelfth month respectively.</time_frame>
    <description>Distance in millimeters from the gingival margin to the bottom of the periodontal pocket. It will be recorded at the beginning in all teeth present (except wisdow teeth) in 6 points per tooth (mesio-bucal, mid-bucal, disto-bucal, mesio-lingual, mid-lingual and disto-lingual) and, during follow-up, only in the recessions to be treated at the vestibular mid-point.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient bleeding index (BI)</measure>
    <time_frame>Change from baseline at following surgery sixth and twelfth month respectively.</time_frame>
    <description>After a periodontal probing of all teeth, the presence (yes or no) of bleeding is recorded dichotomously at 6 points per tooth (mesio-bucal, mid-bucal, disto-bucal, mesio-lingual, mid-lingual and disto-lingual) and the percentage of sites that bleed from the total of probed sites is calculated (Ainamo and Bay 1975).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Patient plaque index (PI)</measure>
    <time_frame>Change from baseline at following surgery sixth and twelfth month respectively.</time_frame>
    <description>A plaque developer is used and the presence (yes or no) of plaque is recorded dichotomously at 6 points per tooth (mesio-bucal, mid-bucal, disto-bucal, mesio-lingual, mid-lingual and disto-lingual) and the percentage of sites with plaque of the total probed sites is calculated (O'Leary et al 1972).</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Gingival Recessions</condition>
  <arm_group>
    <arm_group_label>Modified vestibular incision subperiosteal tunnel access</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Test group: Coverage of Class III multiples gingival recessions with the application of Modified vestibular incision subperiosteal tunnel access technique and a connective tissue graft from the palate.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Coronally advanced flap</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group: Coverage of Class III multiples gingival recessions with the application of Coronally advanced flap and a connective tissue graft from the palate.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Modified vestibular incision subperiosteal tunnel access</intervention_name>
    <description>Single vertical mucosal incision, in the middel of the area to be treated, from which we began to lift a mucoperiosteal flap in a single plane.&#xD;
With a micro-scalpel intrasulcular incisions are made extending to the base of the papillas.&#xD;
Preparation of a tunnel in the same plane. Take a connective tissue graft on the same side of the palate. The connective graft is inserted through the vertical incision prepared with the aid of the suture.&#xD;
All is stabilized by means of suspensory sutures of coronal traction on each point of contact.&#xD;
Finally the vertical incision made is sutured.</description>
    <arm_group_label>Modified vestibular incision subperiosteal tunnel access</arm_group_label>
    <other_name>m-VISTA</other_name>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Coronally advanced flap</intervention_name>
    <description>Oblique submarginal incisions in both interdental areas of each recession, which continue with the intrasulcular incision, one tooth extending on each side of the teeth to be treated.&#xD;
A partial-total-partial thickness flap is elevated in the coronal-apical direction.&#xD;
A vestibular mucosal dissection is performed to eliminate muscle tension. The remnant tissue of the anatomical interdental papillas is desepithelized. Take a CTG on the same side of the palate. The connective tissue graft is stabilized with resorbable suture over the recessions with suspensory sutures on the teeth.&#xD;
Finally, suspensory sutures with non-resorbable sutures are also used to achieve an accurate adaptation of the vestibular flap over the exposed root and stabilize each surgical papilla over each desepithelized interdental area.</description>
    <arm_group_label>Coronally advanced flap</arm_group_label>
    <other_name>CAF</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients of the Master of Periodontology of the UPV / EHU.&#xD;
&#xD;
          -  Age ≥ 18 years.&#xD;
&#xD;
          -  Multiple recessions (more than two) Class III ≥ 2 mm deep, in which the interdental&#xD;
             papilla does not extend beyond the cementoenamel line.&#xD;
&#xD;
          -  Absence of active periodontal disease.&#xD;
&#xD;
          -  Plaque index (O'Leary et al. 1972) and bleeding index (Ainamo and Bay 1975) ≤15%.&#xD;
&#xD;
          -  Informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Smokers &gt; 10 cigarettes / day.&#xD;
&#xD;
          -  Subjects with systemic conditions that contraindicate surgery.&#xD;
&#xD;
          -  Subjects that have taken analgesics and anti-inflammatory drugs in the last 72 hours.&#xD;
&#xD;
          -  Subjects taking opioids, anticonvulsants and antidepressants except serotonin&#xD;
             selective inhibitors.&#xD;
&#xD;
          -  Women who are pregnant or nursing.&#xD;
&#xD;
          -  Patients who do not wish to participate in the study.&#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>Luis Antonio Aguirre Zorzano, Dr.</last_name>
    <role>Study Director</role>
    <affiliation>University of the Basque Country (UPV/EHU)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aitziber Fernández Jiménez, Lcda.</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of the Basque Country (UPV/EHU)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ruth Estefanía Fresco, Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>University of the Basque Country (UPV/EHU)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Xabier Marichalar Mendia, Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>University of the Basque Country (UPV/EHU)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Aroa Hereñu González, Lcda.</last_name>
    <role>Study Chair</role>
    <affiliation>University of the Basque Country (UPV/EHU)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Jose Manuel Aguirre Urizar, Dr.</last_name>
    <role>Study Director</role>
    <affiliation>University of the Basque Country (UPV/EHU)</affiliation>
  </overall_official>
  <overall_official>
    <last_name>Ana María García de la Fuente, Dr.</last_name>
    <role>Study Chair</role>
    <affiliation>University of the Basque Country (UPV/EHU)</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department fo Stomatology II, Faculty of Medicine and Nursery, University of the Basque Country</name>
      <address>
        <city>Leioa</city>
        <state>Biscay</state>
        <zip>48940</zip>
        <country>Spain</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Spain</country>
  </location_countries>
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  </results_reference>
  <results_reference>
    <citation>Zadeh HH. Minimally invasive treatment of maxillary anterior gingival recession defects by vestibular incision subperiosteal tunnel access and platelet-derived growth factor BB. Int J Periodontics Restorative Dent. 2011 Nov-Dec;31(6):653-60.</citation>
    <PMID>22140667</PMID>
  </results_reference>
  <results_reference>
    <citation>Zucchelli G, De Sanctis M. Treatment of multiple recession-type defects in patients with esthetic demands. J Periodontol. 2000 Sep;71(9):1506-14. doi: 10.1902/jop.2000.71.9.1506.</citation>
    <PMID>11022782</PMID>
  </results_reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>August 18, 2017</study_first_submitted>
  <study_first_submitted_qc>August 21, 2017</study_first_submitted_qc>
  <study_first_posted type="Actual">August 23, 2017</study_first_posted>
  <last_update_submitted>March 7, 2022</last_update_submitted>
  <last_update_submitted_qc>March 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>University of the Basque Country (UPV/EHU)</investigator_affiliation>
    <investigator_full_name>Aitziber Fernandez Jimenez</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Gingival recession</keyword>
  <keyword>Class III gingival recession</keyword>
  <keyword>Multiples gingival recessions</keyword>
  <keyword>Periodontitis</keyword>
  <keyword>Mucogingival surgery</keyword>
  <keyword>Modified vestibular incision subperiosteal tunnel access</keyword>
  <keyword>Coronally advanced flap</keyword>
  <keyword>Connective tissue graft</keyword>
  <keyword>Post-surgical pain</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingival Recession</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Yes</sharing_ipd>
    <ipd_description>The data collected for the study will be identified by a code and only the researcher will be able to relate them. The personal data will be treated with absolute confidentiality in accordance with the Data Protection Law and will remain in the patient's clinical history. The coded data will be included in a UPV/EHU´s file with reference number 2080310015-INA0110, whose head is Ana María García de la Fuente, and will only be used for the purposes of this project.</ipd_description>
  </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/NCT03258996
org study id: 2017_01
nct id: NCT03258996
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The main objective is to assess whether the percentage of root coverage (%RC) achieved in the
      treatment of multiples class III recessions using the technique we have called modified
      vestibular incision subperiosteal tunnel access (m-VISTA), which is a lateral approach
      subperiosteal tunnel technique, combined with a connective tissue graft is greater than that
      achieved through the coronally advance flap (CAF) technique together with a connective tissue
      graft.
The reason for designing this study is that treatment of Class III gingival recessions
      (Miller 1985) continues to be challenging today and, although different techniques have been
      proposed to attempt to improve root coverage results, there is little evidence on what would
      offer better results.

      To achieve those objectives a randomized controlled clinical trial is designed. Using the
      percentage of root coverage as a primary response variable, it is estimated with the
      calculation of the sample size, we would need 11 patients for each treatment group (Domenech
      and Granero 2010). In addition, taking into account possible drop-outs, we would increase the
      number of patients by recruiting a total of 24 patients.

      A same experienced, blind and calibrated (the intraclass correlation coefficient will be at
      least of 0.75) examiner (R.E.) will collect the following periodontal clinical parameters at
      the baseline, and at 6 and 12 months, in each tooth involved, using a periodontal probe:
      Gingival recession, number and location of recessions to be treated, number of treated
      recessions that have a complete root coverage, the width of the gingival recession and the
      keratinized gingiva, the distance from the contact point to the interdental papilla, depth of
      probing, bleeding index and plaque index. And will also collect the opinion of the
      participant regarding pain and the degree of satisfaction with the aesthetic result.

      Students of the University of the Basque Country's (UPV/EHU) Own Degree in Periodontology and
      Osteointegration will perform the corresponding surgical technique (m-VISTA or CAF) depending
      on the randomization sequence obtained. A clinical monitor (A.M.G.) will keep the sequence
      hidden until the moment of the intervention.

      Initially, the subject will not know which technique to receive, the complete information
      regarding the surgical technique used, as the results obtained in his case, will be given in
      the last visit of the year.

      Finally, a blind statistic (X.M) will analyze the data using the SPSS software, having as
      unit of analysis the subject. Doing a descriptive statistics, checking if the groups are
      homogeneous in basal, inter-group, intra-group and change variables comparisons and
      logistical regression to assess the intensity and duration of post-surgical pain adjusted for
      possible confounding factors.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: We will perform the experimental or control technique according to the randomization sequence.
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
masking description: Participant: Initially, the subject will not know what technique has been received, the complete information regarding the surgical technique used, as the results obtained in his case, will be given in the last visit of the year.
Observer: Another periodoncist (R.E.), outside the intervention, would be in charge of recording the clinical parameters.
Analyst: The statistician (X.M.) does not know which treatment corresponds to each variable.
measure: Percentage of root coverage (%CR)
time frame: 12 months
description: In each patient the mean of their gingival recessions at baseline (initial RECm) and at 12 months (RECm_12 months) will be calculated. A new variable called %CR [(RECm_initial - RECm_12 months) / (RECm_initial x 100) will be calculated.
measure: Percentage of recessions with complete root coverage (%CRC)
time frame: 12 months
description: Each patient will record the number of recessions, which after treatment, show complete root coverage at 12 months (CRC_12 months). A new variable called % CRC_12 months [CRC_12meses / NRT x100] will be calculated.
measure: Post-surgical pain perception
time frame: After surgery up to 14 days
description: The subject will we instructed to collect their perception of post-surgical pain in the VAS based Journal of Pain (IDT). Specifically the subject will record: Its intensity (0-100mm), its duration (minutes or hours) and if any analgesic treatment has been necessary (No o Yes: Which?).
measure: Gingival recession (REC)
time frame: Change from baseline at following surgery sixth and twelfth month respectively.
description: Distance in mm from the amelocementaria line the gingival margin, measured at the vestibular midpoint. It will be registered in all the teeth present (except wisdom teeth) at the beginning, and, during the follow-up only in the recessions to be treated.
measure: Post-surgical aesthetic result (VAS aesthetic)
time frame: 12 months
description: The same examiner will evaluate the degree of satisfaction of the subject with the aesthetic result obtained after the intervention, through a Questionnaire based on the Visual Analogue Scale (VAS).
measure: Pre-surgical pain perception
time frame: Baseline.
description: In the VAS based Journal of Pain (IDT) the examiner will record if the subject has had regional head and neck pain in the last month and if there is any pain in the immediate preoperative, if it is affirmative the intensity will be noted.
measure: Post-surgical complications
time frame: After surgery first seven days.
description: The presence or not, as the description, of the post-surgical complications (PSC) that may appear will be collected.
measure: Central Sensitization Inventory severity-level score of the subject
time frame: Baseline.
description: Central Sensitization inventory (CSI) (Mayer et al. 2012) will be done, in which each subject will be asked on the frequency in which he perceives 25 symptoms and will be given a score of 0-4 finally establishing a clinical level in a range of 0-100 points (Subclinical: 0-29; Medium: 30-39; Moderate: 40-49 ; Severe: 50-59; Extreme: 60-100).
measure: Number of recessions to be treated (NRT) Number of recessions to be treated (NRT)
time frame: Baseline.
description: Number of Class III recessions to be treated will be recorded.
measure: Localization of the recessions to treat (LRT)
time frame: Baseline.
description: On the one hand, upper recessions will be considered the located in the maxillary and on the other hand, lower recessions those located in the mandible.
measure: Gingival recession width (GRW)
time frame: Change from baseline at following surgery sixth and twelfth month respectively.
description: Mesio-distal distance taken in the coronal area of the same, measured in millimeters. It will be recorded only in the recessions to be treated.
measure: Keratinized gingiva width (KGW)
time frame: Change from baseline at following surgery sixth and twelfth month respectively.
description: Distance in millimeters from the mucogingival junction to the gingival margin, measured at the vestibular midpoint. It will be recorded only in the recessions to be treated.
measure: Distance from contact point to the interdental papilla (CP-IP)
time frame: Change from baseline at following surgery sixth and twelfth month respectively.
description: Distance in millimeters from the mesial and distal contact point of the tooth with recession, to the most coronal part of the interdental papilla. It will be recorded only in the recessions to be treated.
measure: Probing depth (PD)
time frame: Change from baseline at following surgery sixth and twelfth month respectively.
description: Distance in millimeters from the gingival margin to the bottom of the periodontal pocket. It will be recorded at the beginning in all teeth present (except wisdow teeth) in 6 points per tooth (mesio-bucal, mid-bucal, disto-bucal, mesio-lingual, mid-lingual and disto-lingual) and, during follow-up, only in the recessions to be treated at the vestibular mid-point.
measure: Patient bleeding index (BI)
time frame: Change from baseline at following surgery sixth and twelfth month respectively.
description: After a periodontal probing of all teeth, the presence (yes or no) of bleeding is recorded dichotomously at 6 points per tooth (mesio-bucal, mid-bucal, disto-bucal, mesio-lingual, mid-lingual and disto-lingual) and the percentage of sites that bleed from the total of probed sites is calculated (Ainamo and Bay 1975).
measure: Patient plaque index (PI)
time frame: Change from baseline at following surgery sixth and twelfth month respectively.
description: A plaque developer is used and the presence (yes or no) of plaque is recorded dichotomously at 6 points per tooth (mesio-bucal, mid-bucal, disto-bucal, mesio-lingual, mid-lingual and disto-lingual) and the percentage of sites with plaque of the total probed sites is calculated (O'Leary et al 1972).
arm group label: Modified vestibular incision subperiosteal tunnel access
arm group type: Experimental
description: Test group: Coverage of Class III multiples gingival recessions with the application of Modified vestibular incision subperiosteal tunnel access technique and a connective tissue graft from the palate.
arm group label: Coronally advanced flap
arm group type: Active Comparator
description: Control group: Coverage of Class III multiples gingival recessions with the application of Coronally advanced flap and a connective tissue graft from the palate.
intervention type: Procedure
intervention name: Modified vestibular incision subperiosteal tunnel access
description: Single vertical mucosal incision, in the middel of the area to be treated, from which we began to lift a mucoperiosteal flap in a single plane.
With a micro-scalpel intrasulcular incisions are made extending to the base of the papillas.
Preparation of a tunnel in the same plane. Take a connective tissue graft on the same side of the palate. The connective graft is inserted through the vertical incision prepared with the aid of the suture.
All is stabilized by means of suspensory sutures of coronal traction on each point of contact.
Finally the vertical incision made is sutured.
arm group label: Modified vestibular incision subperiosteal tunnel access
other name: m-VISTA
intervention type: Procedure
intervention name: Coronally advanced flap
description: Oblique submarginal incisions in both interdental areas of each recession, which continue with the intrasulcular incision, one tooth extending on each side of the teeth to be treated.
A partial-total-partial thickness flap is elevated in the coronal-apical direction.
A vestibular mucosal dissection is performed to eliminate muscle tension. The remnant tissue of the anatomical interdental papillas is desepithelized. Take a CTG on the same side of the palate. The connective tissue graft is stabilized with resorbable suture over the recessions with suspensory sutures on the teeth.
Finally, suspensory sutures with non-resorbable sutures are also used to achieve an accurate adaptation of the vestibular flap over the exposed root and stabilize each surgical papilla over each desepithelized interdental area.
arm group label: Coronally advanced flap
other name: CAF
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Luis Antonio Aguirre Zorzano, Dr.
role: Study Director
affiliation: University of the Basque Country (UPV/EHU)
last name: Aitziber Fernández Jiménez, Lcda.
role: Principal Investigator
affiliation: University of the Basque Country (UPV/EHU)
last name: Ruth Estefanía Fresco, Dr.
role: Study Chair
affiliation: University of the Basque Country (UPV/EHU)
last name: Xabier Marichalar Mendia, Dr.
role: Study Chair
affiliation: University of the Basque Country (UPV/EHU)
last name: Aroa Hereñu González, Lcda.
role: Study Chair
affiliation: University of the Basque Country (UPV/EHU)
last name: Jose Manuel Aguirre Urizar, Dr.
role: Study Director
affiliation: University of the Basque Country (UPV/EHU)
last name: Ana María García de la Fuente, Dr.
role: Study Chair
affiliation: University of the Basque Country (UPV/EHU)
facility: 
country: Spain
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citation: Aroca S, Keglevich T, Barbieri B, Gera I, Etienne D. Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study. J Periodontol. 2009 Feb;80(2):244-52. doi: 10.1902/jop.2009.080253.
PMID: 19186964
citation: Aroca S, Molnar B, Windisch P, Gera I, Salvi GE, Nikolidakis D, Sculean A. Treatment of multiple adjacent Miller class I and II gingival recessions with a Modified Coronally Advanced Tunnel (MCAT) technique and a collagen matrix or palatal connective tissue graft: a randomized, controlled clinical trial. J Clin Periodontol. 2013 Jul;40(7):713-20. doi: 10.1111/jcpe.12112. Epub 2013 Apr 30.
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PMID: 17309597
citation: Del Corso M, Sammartino G, Dohan Ehrenfest DM. Re: "Clinical evaluation of a modified coronally advanced flap alone or in combination with a platelet-rich fibrin membrane for the treatment of adjacent multiple gingival recessions: a 6-month study". J Periodontol. 2009 Nov;80(11):1694-7; author reply 1697-9. doi: 10.1902/jop.2009.090253.
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citation: Zadeh HH. Minimally invasive treatment of maxillary anterior gingival recession defects by vestibular incision subperiosteal tunnel access and platelet-derived growth factor BB. Int J Periodontics Restorative Dent. 2011 Nov-Dec;31(6):653-60.
PMID: 22140667
citation: Zucchelli G, De Sanctis M. Treatment of multiple recession-type defects in patients with esthetic demands. J Periodontol. 2000 Sep;71(9):1506-14. doi: 10.1902/jop.2000.71.9.1506.
PMID: 11022782
responsible party type: Sponsor-Investigator
investigator affiliation: University of the Basque Country (UPV/EHU)
investigator full name: Aitziber Fernandez Jimenez
investigator title: Principal Investigator
mesh term: Gingival Recession
sharing ipd: Yes
ipd description: The data collected for the study will be identified by a code and only the researcher will be able to relate them. The personal data will be treated with absolute confidentiality in accordance with the Data Protection Law and will remain in the patient's clinical history. The coded data will be included in a UPV/EHU´s file with reference number 2080310015-INA0110, whose head is Ana María García de la Fuente, and will only be used for the purposes of this project.