xml: <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/NCT06000228</url>
    </required_header>
    <id_info>
      <org_study_id>Sushma Periodontics 2022</org_study_id>
      <nct_id>NCT06000228</nct_id>
    </id_info>
    <brief_title>Effect of Vestibular Depth on Predictability of Miller Class III/ RT2 Gingival Recession Coverage</brief_title>
    <official_title>&quot;Effect of Vestibular Depth on Root Coverage Predictability in Miller Class III/Recession Type 2 Labial Gingival Recession Treated With Minimally Invasive Technique Using Connective Tissue Graft: A Prospective Cohort Study</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Postgraduate Institute of Dental Sciences Rohtak</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Postgraduate Institute of Dental Sciences Rohtak</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>
        Aim of this study is to assess the influence of vestibular depth on root coverage in Miller&#xD;
        class III/ Cairo RT2 gingival recession when treated with minimally invasive technique using&#xD;
        connective tissue graft.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Gingival recession is defined as partial exposure of the root surface to the oral cavity&#xD;
        because of apical migration of the gingival margin (GM) with respect to the cemento-enamel&#xD;
        junction (CEJ). Miller class III/Cairo RT2 gingival recession most common gingival recession&#xD;
        where patient complaint of root sensitivity, root caries and wedge shape defect. Several&#xD;
        mucogingival approaches have been proposed such as tunnel techniques, coronally advanced&#xD;
        flap(most common), connective tissue graft, rotated flap. Local factor that influences the&#xD;
        surgical intervention and outcome therapy is interproximal bone and attachment level,&#xD;
        marginal gingival thickness (MGT), width of attached gingiva, and recession defect depth (RD)&#xD;
        clinical attachment level (CAL). In recent publication Aroca et al. studied influence of&#xD;
        distance from tip of the papilla and the contact point (DCP) on recession coverage outcome&#xD;
        and concluded that the probability to obtain a complete root coverage decreases when the DCP&#xD;
        at baseline increases. Another finding of recent case series shown association of vestibular&#xD;
        depth (VD) and outcome in terms of % root coverage (%RC) and complete complete coverage (CRC)&#xD;
        and revealed that each additional 1mm VD increased 2.75 times the probability of achieving&#xD;
        CRC but they have not compared the root coverage outcome in deep and shallow vestibular&#xD;
        depth. Therefore, this study will be conducted in Miller class III/RT2 labial gingival&#xD;
        recession to observed the impact of vestibular depth on root coverage when treating with&#xD;
        minimally invasive technique using connective tissue graft.&#xD;
  &#xD;
        AIM AND OBJECTIVE To assess the influence of vestibular depth on root coverage in Miller&#xD;
        class III/ Cairo RT2 gingival recession when treated with minimally invasive technique using&#xD;
        connective tissue graft.&#xD;
  &#xD;
        Primary objective Comparative evaluation of percentage of recession coverage and complete&#xD;
        root coverage in shallow and deep vestibular depth in Miller class III/ Cairo RT2 when&#xD;
        treated with minimally invasive technique using connective tissue graft and also evaluated&#xD;
        RD, RW, Gingiva phenotype, patient-based evaluation of pain and hypersensitivity by visual&#xD;
        analogue scale(VAS)&#xD;
  &#xD;
        Secondary objective To assess the improvement to other clinical parameter which will include&#xD;
        clinical attachment level (CAL), Interdental clinical attachment, Mid buccal clinical&#xD;
        attachment, Pocket probing depth (PPD), Bleeding on probing (BOP), Plaque index (PI),&#xD;
        Gingival thickness (GT), Keratinized tissue width (KTW), Root aesthetic score (RES).&#xD;
  &#xD;
        STUDY DESIGN Prospective cohort study&#xD;
  &#xD;
        STUDY SETTING Hospital based study, and will be conducted in department of Periodontics, Post&#xD;
        graduate institute of dental science, Rohtak.&#xD;
  &#xD;
        STUDY PERIOD 12 to 14 months follow up&#xD;
  &#xD;
        STUDY SUBJECT Systemically healthy individuals with Miller class III/Cairo RT2 labial&#xD;
        gingival recession will be recruited from the outpatient department of periodontology.&#xD;
  &#xD;
        Patients fulfilling the eligibility criteria will be enrolled in the study after obtaining an&#xD;
        informed written consent.&#xD;
  &#xD;
        MATERIAL AND METHOD&#xD;
  &#xD;
        Patient will be educated about the procedure and its implication. Scaling and root planing is&#xD;
        performed and then participants will be instructed about oral hygiene and undergo&#xD;
        intervention therapy.&#xD;
  &#xD;
        After administration of local anesthesia, exposed root surface will be planed using curettes&#xD;
        or by using bur to reduce the prominent root. With a minimally invasive access technique a&#xD;
        full thickness tunnel will be prepared with specific tunneling instruments, extending it&#xD;
        sufficiently beyond the mucogingival line into alveolar mucosa, this will be done to&#xD;
        completely releasing the tunnel-papillae complex, thus facilitating its passive coronal&#xD;
        replacement. connective tissue graft will be procured from the palate or tuberosity area for&#xD;
        root coverage procedure by single incision technique. The palatal wound will be sutured (5-0)&#xD;
        to obtain primary wound closure Then after surgery patient will be recalled after 10 -12 days&#xD;
        and then again at 1, 3, 6 months.&#xD;
  &#xD;
        STUDY GROUPS&#xD;
  &#xD;
        Experimental group- Miller class III/RT2 labial gingival recession associated with shallow&#xD;
        vestibule.&#xD;
  &#xD;
        Active comparator- Miller class III/RT2 labial gingival recession associated with deep&#xD;
        vestibule.&#xD;
  &#xD;
        STATISTICAL ANALYSIS Data recorded will be processed by standard statistical analysis. The&#xD;
        normality of distribution of data will be examined by Shapiro Wilk test. Statistical analysis&#xD;
        will be performed according to distribution of data. If it is in normal distribution inter&#xD;
        group comparison will be done by using Independent T test and paired t test will be used for&#xD;
        intragroup comparison and if non-normal distribution of data, inter group comparison will be&#xD;
        done by Mann-Whitney U test and intragroup by signed rank test. The Chi square test will be&#xD;
        applied to analysed categoric data. Correlation and association between predictors and&#xD;
        dependent variables will be analysed by correlation analysis and regression analysis.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">January 2025</completion_date>
    <primary_completion_date type="Anticipated">January 2025</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Non-Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Participant)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>percentage root coverage</measure>
      <time_frame>12-14 months</time_frame>
      <description>percentage of root coverage is calculated using formula: Preoperative recession depth-postoperative recession depth/ preoperative recession depth × 100</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">40</enrollment>
    <condition>Gingival Recession, Localized</condition>
    <arm_group>
      <arm_group_label>Shallow vestibule</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Miller class III/ RT2 labial gingival recession associated with vestibular depth less than 6mm</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Deep vestibule</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Miller class III/ RT2 labial gingival recession associated with vestibular depth more than 6mm</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Recession coverage with CTG using minimally invasive access technique in shallow vestibule</intervention_name>
      <description>After enrolment, participants will be instructed about oral hygiene and undergo nonsurgical periodontal treatment in the form of scaling and root planing using ultrasonic and hand instruments as needed. After resolution of inflammation, a full thickness tunnel will be preapred using minimally invasive access technique under local anesthesia with the aid of specific tunnelling instruments and connective tissue graft will be procured from the palate or tuberosity area for root coverage procedure by single incision technique.</description>
      <arm_group_label>Shallow vestibule</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Recession coverage with CTG using minimally invasive access technique in deep vestibule</intervention_name>
      <description>After enrolment, participants will be instructed about oral hygiene and undergo nonsurgical periodontal treatment in the form of scaling and root planing using ultrasonic and hand instruments as needed. After resolution of inflammation, a full thickness tunnel will be preapred using minimally invasive access technique under local anesthesia with the aid of specific tunnelling instruments and connective tissue graft will be procured from the palate or tuberosity area for root coverage procedure by single incision technique.</description>
      <arm_group_label>Deep vestibule</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            1. Adult patients (≥18 years) presenting with isolated Miller class III / Cairo RT2&#xD;
               labial gingival recession defect with deep and shallow vestibular defect.&#xD;
  &#xD;
            2. Absence of clinical tooth mobility.&#xD;
  &#xD;
            3. Age &gt;18 years old.&#xD;
  &#xD;
            4. A full mouth plaque index and full mouth bleeding index &lt; 20%&#xD;
  &#xD;
            5. Patient showing adequate compliance and willing to participate in the study.&#xD;
  &#xD;
            6. CAL (clinical attachment level), RD (recession depth) and KTW (keratinized tissue&#xD;
               depth) will be comparable and matched in both the groups.&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          (1) full-mouth plaque and bleeding score &gt;20%; (2) non smoker; (3) systemic&#xD;
          contraindications for periodontal surgery; (4) taking medications known to affect gingival&#xD;
          homeostasis or interfere with wound healing; (5) pregnancy; (6) active orthodontic therapy;&#xD;
          (7) previous periodontal surgery, caries, or restorations in the experimental site(s); and&#xD;
          (8) malpositioned /crowded teeth.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>18 Years</minimum_age>
      <maximum_age>50 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>sushma Kumari, BDS</last_name>
      <role>Principal Investigator</role>
      <affiliation>Postgraduate Institute of Dental Sciences Rohtak</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Sanjay Tewari, MDS</last_name>
      <phone>01262213876</phone>
      <email>principalpgids@yahoo.in</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Shikha Tewari, MDS</last_name>
      <phone>9416514600</phone>
      <email>drshikhatewari@yahoo.com</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Shikha Tewari</name>
        <address>
          <city>Rohtak</city>
          <state>Haryana</state>
          <zip>124001</zip>
          <country>India</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>India</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 12, 2023</study_first_submitted>
    <study_first_submitted_qc>August 12, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 12, 2023</last_update_submitted>
    <last_update_submitted_qc>August 12, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 21, 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>Gingival Recession</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06000228
  org study id: Sushma Periodontics 2022
  nct id: NCT06000228
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  Aim of this study is to assess the influence of vestibular depth on root coverage in Miller
        class III/ Cairo RT2 gingival recession when treated with minimally invasive technique using
        connective tissue graft.
  Gingival recession is defined as partial exposure of the root surface to the oral cavity
        because of apical migration of the gingival margin (GM) with respect to the cemento-enamel
        junction (CEJ). Miller class III/Cairo RT2 gingival recession most common gingival recession
        where patient complaint of root sensitivity, root caries and wedge shape defect. Several
        mucogingival approaches have been proposed such as tunnel techniques, coronally advanced
        flap(most common), connective tissue graft, rotated flap. Local factor that influences the
        surgical intervention and outcome therapy is interproximal bone and attachment level,
        marginal gingival thickness (MGT), width of attached gingiva, and recession defect depth (RD)
        clinical attachment level (CAL). In recent publication Aroca et al. studied influence of
        distance from tip of the papilla and the contact point (DCP) on recession coverage outcome
        and concluded that the probability to obtain a complete root coverage decreases when the DCP
        at baseline increases. Another finding of recent case series shown association of vestibular
        depth (VD) and outcome in terms of % root coverage (%RC) and complete complete coverage (CRC)
        and revealed that each additional 1mm VD increased 2.75 times the probability of achieving
        CRC but they have not compared the root coverage outcome in deep and shallow vestibular
        depth. Therefore, this study will be conducted in Miller class III/RT2 labial gingival
        recession to observed the impact of vestibular depth on root coverage when treating with
        minimally invasive technique using connective tissue graft.
  
        AIM AND OBJECTIVE To assess the influence of vestibular depth on root coverage in Miller
        class III/ Cairo RT2 gingival recession when treated with minimally invasive technique using
        connective tissue graft.
  
        Primary objective Comparative evaluation of percentage of recession coverage and complete
        root coverage in shallow and deep vestibular depth in Miller class III/ Cairo RT2 when
        treated with minimally invasive technique using connective tissue graft and also evaluated
        RD, RW, Gingiva phenotype, patient-based evaluation of pain and hypersensitivity by visual
        analogue scale(VAS)
  
        Secondary objective To assess the improvement to other clinical parameter which will include
        clinical attachment level (CAL), Interdental clinical attachment, Mid buccal clinical
        attachment, Pocket probing depth (PPD), Bleeding on probing (BOP), Plaque index (PI),
        Gingival thickness (GT), Keratinized tissue width (KTW), Root aesthetic score (RES).
  
        STUDY DESIGN Prospective cohort study
  
        STUDY SETTING Hospital based study, and will be conducted in department of Periodontics, Post
        graduate institute of dental science, Rohtak.
  
        STUDY PERIOD 12 to 14 months follow up
  
        STUDY SUBJECT Systemically healthy individuals with Miller class III/Cairo RT2 labial
        gingival recession will be recruited from the outpatient department of periodontology.
  
        Patients fulfilling the eligibility criteria will be enrolled in the study after obtaining an
        informed written consent.
  
        MATERIAL AND METHOD
  
        Patient will be educated about the procedure and its implication. Scaling and root planing is
        performed and then participants will be instructed about oral hygiene and undergo
        intervention therapy.
  
        After administration of local anesthesia, exposed root surface will be planed using curettes
        or by using bur to reduce the prominent root. With a minimally invasive access technique a
        full thickness tunnel will be prepared with specific tunneling instruments, extending it
        sufficiently beyond the mucogingival line into alveolar mucosa, this will be done to
        completely releasing the tunnel-papillae complex, thus facilitating its passive coronal
        replacement. connective tissue graft will be procured from the palate or tuberosity area for
        root coverage procedure by single incision technique. The palatal wound will be sutured (5-0)
        to obtain primary wound closure Then after surgery patient will be recalled after 10 -12 days
        and then again at 1, 3, 6 months.
  
        STUDY GROUPS
  
        Experimental group- Miller class III/RT2 labial gingival recession associated with shallow
        vestibule.
  
        Active comparator- Miller class III/RT2 labial gingival recession associated with deep
        vestibule.
  
        STATISTICAL ANALYSIS Data recorded will be processed by standard statistical analysis. The
        normality of distribution of data will be examined by Shapiro Wilk test. Statistical analysis
        will be performed according to distribution of data. If it is in normal distribution inter
        group comparison will be done by using Independent T test and paired t test will be used for
        intragroup comparison and if non-normal distribution of data, inter group comparison will be
        done by Mann-Whitney U test and intragroup by signed rank test. The Chi square test will be
        applied to analysed categoric data. Correlation and association between predictors and
        dependent variables will be analysed by correlation analysis and regression analysis.
  allocation: Non-Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Participant)
  measure: percentage root coverage
  time frame: 12-14 months
  description: percentage of root coverage is calculated using formula: Preoperative recession depth-postoperative recession depth/ preoperative recession depth × 100
  arm group label: Shallow vestibule
  arm group type: Experimental
  description: Miller class III/ RT2 labial gingival recession associated with vestibular depth less than 6mm
  arm group label: Deep vestibule
  arm group type: Active Comparator
  description: Miller class III/ RT2 labial gingival recession associated with vestibular depth more than 6mm
  intervention type: Procedure
  intervention name: Recession coverage with CTG using minimally invasive access technique in shallow vestibule
  description: After enrolment, participants will be instructed about oral hygiene and undergo nonsurgical periodontal treatment in the form of scaling and root planing using ultrasonic and hand instruments as needed. After resolution of inflammation, a full thickness tunnel will be preapred using minimally invasive access technique under local anesthesia with the aid of specific tunnelling instruments and connective tissue graft will be procured from the palate or tuberosity area for root coverage procedure by single incision technique.
  arm group label: Shallow vestibule
  intervention type: Procedure
  intervention name: Recession coverage with CTG using minimally invasive access technique in deep vestibule
  description: After enrolment, participants will be instructed about oral hygiene and undergo nonsurgical periodontal treatment in the form of scaling and root planing using ultrasonic and hand instruments as needed. After resolution of inflammation, a full thickness tunnel will be preapred using minimally invasive access technique under local anesthesia with the aid of specific tunnelling instruments and connective tissue graft will be procured from the palate or tuberosity area for root coverage procedure by single incision technique.
  arm group label: Deep vestibule
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: 50 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: sushma Kumari, BDS
  role: Principal Investigator
  affiliation: Postgraduate Institute of Dental Sciences Rohtak
  last name: Sanjay Tewari, MDS
  phone: 01262213876
  email: principalpgids@yahoo.in
  last name: Shikha Tewari, MDS
  phone: 9416514600
  email: drshikhatewari@yahoo.com
  facility: 
  country: India
  responsible party type: Sponsor
  mesh term: Gingival Recession
  sharing ipd: No