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/NCT06037161</url>
    </required_header>
    <id_info>
      <org_study_id>STUDY20220902</org_study_id>
      <nct_id>NCT06037161</nct_id>
    </id_info>
    <brief_title>Comparison of Two Methods of Covering a Single Lower Front Tooth With Receded Gums</brief_title>
    <official_title>Comparison of Surgical Techniques to Treat Isolated Gingival Recession in Mandibular Incisors: A Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Case Western Reserve University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Case Western Reserve University</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>
        The primary objective of this randomized clinical trial is to compare the mean root coverage&#xD;
        achieved with Coronally Advanced Flap (CAF) + Connective Tissue Graft (CTG) (control) to&#xD;
        Gingival Pedicle Split Thickness flap (GPST) + CTG (test) for the treatment of isolated&#xD;
        gingival recession defects in mandibular incisors. The secondary objectives are to compare&#xD;
        the percentage of complete root coverage and keratinized tissue gain between the two&#xD;
        techniques.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        1. Research Scope: This study focuses on treatment of isolated gingival recession in&#xD;
             mandibular incisors. Coronally advanced flap (CAF) with connective tissue graft (CTG) is&#xD;
             the most predictable surgical technique for recession coverage (Chambrone and Tatakis&#xD;
             2015). However the early data indicate that CAF+CTG provides low predictability of root&#xD;
             coverage of recessions in mandibular incisors (Zucchelli et al. 2014). We recently&#xD;
             described a surgical technique called gingival pedicle split-thickness tunnel&#xD;
             (GPST)+CTG. This technique entails a modified flap design to maximize recession coverage&#xD;
             in mandibular incisors (Agusto et al 2019). The preliminary data using GPST+CTG shows&#xD;
             complete root coverage in 98% of the treated sites (Schincaglia et al.2022). This study&#xD;
             will compare CAF+CTG versus GPST+CTG for the management of isolated gingival recession&#xD;
             in mandibular incisors. Clinical measurements will be performed at baseline and 6-months&#xD;
             after the surgery to study the difference in results achieved by these two surgical&#xD;
             techniques.&#xD;
  &#xD;
          2. Objectives: The primary objective of this randomized clinical trial is to compare the&#xD;
             mean root coverage achieved with CAF+CTG (control) to GPST+CTG (test) for the treatment&#xD;
             of isolated gingival recession defects in mandibular incisors. The secondary objectives&#xD;
             are to compare the percentage of complete root coverage and keratinized tissue gain&#xD;
             between the two techniques.&#xD;
  &#xD;
          3. Hypothesis: It is predicted that the GPST+CTG technique will be superior to CAF+CTG in&#xD;
             terms of mean root coverage, complete root coverage and keratinized tissue gain at&#xD;
             6-months post-surgery.&#xD;
  &#xD;
          4. Justification for the proposal: Although subepithelial connective tissue graft is&#xD;
             considered the gold standard approach for the management of gingival recessions&#xD;
             (Chambrone and Tatakis 2015; Greenwell et al. 2005), data indicates lower efficacy of&#xD;
             CAF+CTG in the treatment of isolated gingival recession in mandibular incisors.&#xD;
             Anatomical challenges in this area such as muscular tension, high labial frenum&#xD;
             insertion, limited tissue thickness and vestibular depth seem to reduce the&#xD;
             predictability of the procedure (Zucchelli et al. 2014). The use of a modified flap&#xD;
             design (GPST) in combination with CTG was introduced by our group to treat isolated&#xD;
             advanced gingival recession in mandibular incisors. This technique seems to provide a&#xD;
             higher success rate for root coverage in this specific clinical condition. A predictable&#xD;
             technique for the treatment of isolated recession defects in mandibular incisors is&#xD;
             needed since gingival recessions on mandibular incisors represent 42% of the total&#xD;
             prevalence of recessions in the general population (Mythri et al. 2015). In addition, a&#xD;
             technique that provides high predictability for root coverage will eliminate or minimize&#xD;
             the need for revision surgical procedures. A revision surgery is performed when the&#xD;
             first surgical procedure did not achieve the desired clinical results. Eliminating the&#xD;
             need of a revision procedure will save time for the clinician and will eliminate pain&#xD;
             and discomfort of an additional surgical procedure to the patient.&#xD;
  &#xD;
        This study will be conducted as a single-blinded, randomized controlled clinical trial in&#xD;
        accordance with the CONSORT guidelines (Moher et al., 2012). Upon approval of the partial&#xD;
        HIPAA waiver, pre-screening will take place through a phone questionnaire for subjects&#xD;
        recruited through flyers and social media to assess for preliminary eligibility. The study&#xD;
        will include the following phases: 1. Screening and recruiting 2. Initial therapy, baseline&#xD;
        clinical measurements 3. Surgical therapy 4. Post-operative follow-up at 2-, 6-weeks 5.&#xD;
        Clinical measurements at 6-months after surgery. Screening and recruiting: Upon consenting,&#xD;
        screening will include gathering patient's personal information, medical history through&#xD;
        questionnaires and clinical examination to confirm eligibility. Medical consultation with the&#xD;
        patient's physician might be requested upon need. Initial therapy and clinical measurements:&#xD;
        Following the screening examination, all subjects will receive a session of prophylaxis&#xD;
        including instructions in proper oral hygiene measures. All clinical measurements at baseline&#xD;
        and 6-months after surgery will be carried out by a calibrated examiner blinded to the&#xD;
        provided treatment. Recession depth, and keratinized tissue height will be measured at the&#xD;
        mid-buccal aspect of the treated tooth; probing depth, and clinical attachment level will be&#xD;
        measured at the mesial, mid, and distal buccal/lingual aspect of the treated tooth; recession&#xD;
        width will also be measured. Position of frenal attachment will be documented. All&#xD;
        measurements will be performed by means of a PCP-15 manual periodontal probe and will be&#xD;
        rounded up to the nearest millimeter. Recession depth will be measured as the distance&#xD;
        between the cemento-enamel junction and gingival margin. Keratinized tissue height will be&#xD;
        measured as the distance between the gingival margin and mucogingival junction. Intra-oral&#xD;
        scanners will be used to capture scans at baseline and 6-months post-surgery. Randomization:&#xD;
        Subjects will be assigned to one of the two treatment groups by blinded allocation.&#xD;
        Randomization will be obtained with the use of computer-generated block randomization. The&#xD;
        sealed envelope with treatment allocation will be assigned by the participant research number&#xD;
        and opened at time of the surgery immediately before the treatment of the root surface.&#xD;
        Surgical therapy: Under local anesthesia, a bilaminar (CAF+CTG) technique will be performed&#xD;
        in the control group and a bilaminar (GPST+CTG) will be performed in the test group to&#xD;
        accomplish root coverage. For CAF+CTG, in brief, exposed root surfaces will be mechanically&#xD;
        treated with the use of curettes, a trapezoidal flap will be raised split/full thickness and&#xD;
        a CTG will be sutured at the level of the cemento-enamel junction (CEJ). The flap will be&#xD;
        coronally advanced and sutured with sling sutures anchored around the palatal cingulum of&#xD;
        tooth with gingival recessions. For GPST+CTG, in brief, exposed root surfaces will be&#xD;
        mechanically treated with the use of curettes. Starting from the line angle of the CEJ, a&#xD;
        horizontal incision, whose length similar to the recession width, will be made distally or&#xD;
        mesially. The distal point of the horizontal incision will be connected to a vertical&#xD;
        incision which will be extended beyond the mucogingival junction (MGJ) and a split-thickness&#xD;
        pedicle will be elevated. On the opposite side to the recession, a split-thickness tunnel&#xD;
        will be prepared. CTG will be sutured at the level of CEJ with 1/3 of the length inserted&#xD;
        into the prepared tunnel and the rest adapted to the recipient site. Finally, the pedicle&#xD;
        will be rotated mesially to passively cover the middle portion of the graft and secured&#xD;
        without tension. The CTG will be harvested from the palate using the single incision&#xD;
        technique (Hurzeler and Weng 1999) or deepithelialized free gingival graft technique&#xD;
        (Zucchelli et al 2010). The minimum thickness of CTG will be kept at 1.5 mm. Post-operative&#xD;
        pain and edema will be controlled with ibuprofen 400 mg every 6-8 hours as needed. Patients&#xD;
        will be instructed not to brush their teeth in the treated area but to rinse with&#xD;
        chlorhexidine solution (0.12%) two times a day for 30 sec. for 6-weeks. Fourteen days after&#xD;
        the surgical treatment, the sutures will be removed. Procedures done to ensure safety and&#xD;
        minimize risks: The research team assembled have sufficient expertise and experience to&#xD;
        conduct the research and will ensure that the projected sample size is sufficient to yield&#xD;
        useful results. The surgical techniques being tested in this study are predictable procedures&#xD;
        performed according to the current standards of care. The surgeries will be done by the&#xD;
        residents of the Periodontics Department at CWRU, under strict supervision of a&#xD;
        board-certified periodontist. Consequently, the delivery of standardized treatment of high&#xD;
        quality will be ensured. In addition, the procedures will be performed conservatively with&#xD;
        the aid of magnification and illumination to minimize the incidence of complications. The&#xD;
        research team will meet regularly to evaluate the progress of the study, including periodic&#xD;
        assessments of data quality and timelines, participant recruitment, accrual, and retention,&#xD;
        and to ensure data integrity and confidentiality as well as adherence to the protocol&#xD;
  &#xD;
        For subjects who learn about the study through advertisements or social media that express&#xD;
        their interest in participation, pre-screening will be done through phone questionnaires&#xD;
        prior to the actual informed consent/screening visit. Individuals who were deemed eligible in&#xD;
        the pre-screening phase, as well as subjects recruited from the department of Periodontics at&#xD;
        CWRU will be scheduled for an in-person visit. During this visit, they will be presented with&#xD;
        the informed consent forms which will be thoroughly reviewed with each participant in an&#xD;
        estimated time of one hour. Subjects who request a waiting period between being informed and&#xD;
        consenting will be given a period of 48 hours. Upon consenting, screening will take place in&#xD;
        the same visit. Screening will include gathering information such as demographics, medical&#xD;
        history, clinical examination, and inclusion/exclusion criteria assessment. Prophylaxis will&#xD;
        take place in the same visit and oral hygiene instructions will be reinforced. Recruitment&#xD;
        will continue in the same manner and will be concluded upon completion of the sample size in&#xD;
        an estimated period of 24 months. In the subsequent visit, surgeries will be performed&#xD;
        according to the randomized allocation provided by the software. After 2 weeks, subjects will&#xD;
        be asked to come for a 2-week follow-up for suture removal and outcome measurements. At 6&#xD;
        weeks and 6 months from the procedure, primary and secondary outcomes will be recorded again&#xD;
        to enable comparing the changes from the baseline between the two surgical methods. The total&#xD;
        timeline of the study is estimated to be around 36 months.&#xD;
  &#xD;
        Sample size: The study is powered to detect a minimum clinically significant difference in&#xD;
        root coverage of 1 mm using alpha = 0.05, a power = 80%, a hypothesized within-group sigma of&#xD;
        1 mm, obtained from previous studies. A total of 36 subjects will be recruited with an&#xD;
        anticipated attrition of 20%. A minimum total of 30 subjects would be needed (15 test and 15&#xD;
        control) for an anticipated power of 84%. Proposed Analysis: The D'Agostino &amp; Pearson&#xD;
        normality test will be applied for each variable to test for normality. Descriptive&#xD;
        statistics will be used for demographics while continuous variables will be tested for normal&#xD;
        distribution using parametric tests such as paired T-test or two-group Analysis of Variance&#xD;
        (ANOVA) with repeated measures, with follow-up Tukey's Honestly Significant Difference (HSD)&#xD;
        tests as appropriate. Non-parametric data will be tested using Kruskal-Wallis or Mann Whitney&#xD;
        U test.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Actual">May 19, 2023</start_date>
    <completion_date type="Anticipated">July 30, 2025</completion_date>
    <primary_completion_date type="Anticipated">January 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>Single Group Assignment</intervention_model>
      <primary_purpose>Treatment</primary_purpose>
      <masking>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Percentage of mean root coverage</measure>
      <time_frame>6 months</time_frame>
      <description>The mean of the amount of root coverage will be calculated within and between test and control groups.</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Percentage of complete root coverage</measure>
      <time_frame>6 months</time_frame>
      <description>The percentage of teeth that achieved complete root coverage will be compared between test and control.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Keratinized Tissue gain.</measure>
      <time_frame>6 months</time_frame>
      <description>The changes in the amount of keratinized tissue from baseline to 6 months will calculated within and between study groups</description>
    </secondary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">36</enrollment>
    <condition>Recession, Gingival</condition>
    <arm_group>
      <arm_group_label>GPST + CTG</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Gingival Pedicle Split Thickness + Connective Tissue Graft procedure</description>
    </arm_group>
    <arm_group>
      <arm_group_label>CAF + CTG</arm_group_label>
      <arm_group_type>Active Comparator</arm_group_type>
      <description>Coronally Advanced Flap + Connective Tissue Graft procedure</description>
    </arm_group>
    <intervention>
      <intervention_type>Procedure</intervention_type>
      <intervention_name>Mandibular Incisor root coverage procedure</intervention_name>
      <description>Mucogingival procedure to cover mandibular incisor tooth with receded gums</description>
      <arm_group_label>CAF + CTG</arm_group_label>
      <arm_group_label>GPST + CTG</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Males and females of &gt; 18 years of age&#xD;
  &#xD;
            -  Single Cairo's RT1 (Recession Type 1) and RT2 ( Recession Type 2) recession defects&#xD;
               (≥3 mm in depth) in mandibular anterior teeth (Incisors).&#xD;
  &#xD;
            -  Presence of identifiable cemento-enamel junction (CEJ)&#xD;
  &#xD;
            -  Presence of a step ≤1 mm at the CEJ level and/or the presence of a root abrasion, but&#xD;
               with an identifiable CEJ, will be accepted&#xD;
  &#xD;
            -  Periodontally and systemically healthy patients&#xD;
  &#xD;
            -  No contraindications for periodontal surgery and not taking medications known to&#xD;
               interfere with periodontal tissue health or healing; and no prior periodontal surgery&#xD;
               on the involved sites&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Vaping, chewing tobacco or smoking &gt; 10 cigarettes per day&#xD;
  &#xD;
            -  Uncontrolled Diabetes Mellitus (HbA1c &gt; 7)&#xD;
  &#xD;
            -  Pregnancy and Lactation&#xD;
  &#xD;
            -  Diseases affecting connective tissue metabolism&#xD;
  &#xD;
            -  Long-term steroid use&#xD;
  &#xD;
            -  Recession defects associated with caries&#xD;
  &#xD;
            -  Teeth associated with pulpal pathology&#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>Gian Pietro Schincaglia, DDS, PhD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Case Western Reserve University</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gian Pietro Schincaglia, DDS,PhD</last_name>
      <phone>2163684412</phone>
      <email>gxs486@case.edu</email>
    </overall_contact>
    <overall_contact_backup>
      <last_name>Clara Sous</last_name>
      <phone>2163684412</phone>
      <email>cms395@case.edu</email>
    </overall_contact_backup>
    <location>
      <facility>
        <name>Case Western Reserve University School of Dental Medicine</name>
        <address>
          <city>Cleveland</city>
          <state>Ohio</state>
          <zip>44106</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Gian Schincaglia</last_name>
        <email>gxs486@case.edu</email>
      </contact>
      <contact_backup>
        <last_name>Clara Sous</last_name>
        <phone>2162006971</phone>
        <email>cms395@case.edu</email>
      </contact_backup>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 30, 2023</study_first_submitted>
    <study_first_submitted_qc>September 7, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 14, 2023</study_first_posted>
    <last_update_submitted>September 7, 2023</last_update_submitted>
    <last_update_submitted_qc>September 7, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Case Western Reserve University</investigator_affiliation>
      <investigator_full_name>Gian Schincaglia</investigator_full_name>
      <investigator_title>Professor, Chair and Graduate Program Director</investigator_title>
    </responsible_party>
    <keyword>Connective tissue graft(s)</keyword>
    <keyword>cosmetic periodontal plastic surgery</keyword>
    <keyword>gingival recession</keyword>
    <keyword>mucogingival surgery</keyword>
    <keyword>treatment planning</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>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/NCT06037161
  org study id: STUDY20220902
  nct id: NCT06037161
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The primary objective of this randomized clinical trial is to compare the mean root coverage
        achieved with Coronally Advanced Flap (CAF) + Connective Tissue Graft (CTG) (control) to
        Gingival Pedicle Split Thickness flap (GPST) + CTG (test) for the treatment of isolated
        gingival recession defects in mandibular incisors. The secondary objectives are to compare
        the percentage of complete root coverage and keratinized tissue gain between the two
        techniques.
  1. Research Scope: This study focuses on treatment of isolated gingival recession in
             mandibular incisors. Coronally advanced flap (CAF) with connective tissue graft (CTG) is
             the most predictable surgical technique for recession coverage (Chambrone and Tatakis
             2015). However the early data indicate that CAF+CTG provides low predictability of root
             coverage of recessions in mandibular incisors (Zucchelli et al. 2014). We recently
             described a surgical technique called gingival pedicle split-thickness tunnel
             (GPST)+CTG. This technique entails a modified flap design to maximize recession coverage
             in mandibular incisors (Agusto et al 2019). The preliminary data using GPST+CTG shows
             complete root coverage in 98% of the treated sites (Schincaglia et al.2022). This study
             will compare CAF+CTG versus GPST+CTG for the management of isolated gingival recession
             in mandibular incisors. Clinical measurements will be performed at baseline and 6-months
             after the surgery to study the difference in results achieved by these two surgical
             techniques.
  
          2. Objectives: The primary objective of this randomized clinical trial is to compare the
             mean root coverage achieved with CAF+CTG (control) to GPST+CTG (test) for the treatment
             of isolated gingival recession defects in mandibular incisors. The secondary objectives
             are to compare the percentage of complete root coverage and keratinized tissue gain
             between the two techniques.
  
          3. Hypothesis: It is predicted that the GPST+CTG technique will be superior to CAF+CTG in
             terms of mean root coverage, complete root coverage and keratinized tissue gain at
             6-months post-surgery.
  
          4. Justification for the proposal: Although subepithelial connective tissue graft is
             considered the gold standard approach for the management of gingival recessions
             (Chambrone and Tatakis 2015; Greenwell et al. 2005), data indicates lower efficacy of
             CAF+CTG in the treatment of isolated gingival recession in mandibular incisors.
             Anatomical challenges in this area such as muscular tension, high labial frenum
             insertion, limited tissue thickness and vestibular depth seem to reduce the
             predictability of the procedure (Zucchelli et al. 2014). The use of a modified flap
             design (GPST) in combination with CTG was introduced by our group to treat isolated
             advanced gingival recession in mandibular incisors. This technique seems to provide a
             higher success rate for root coverage in this specific clinical condition. A predictable
             technique for the treatment of isolated recession defects in mandibular incisors is
             needed since gingival recessions on mandibular incisors represent 42% of the total
             prevalence of recessions in the general population (Mythri et al. 2015). In addition, a
             technique that provides high predictability for root coverage will eliminate or minimize
             the need for revision surgical procedures. A revision surgery is performed when the
             first surgical procedure did not achieve the desired clinical results. Eliminating the
             need of a revision procedure will save time for the clinician and will eliminate pain
             and discomfort of an additional surgical procedure to the patient.
  
        This study will be conducted as a single-blinded, randomized controlled clinical trial in
        accordance with the CONSORT guidelines (Moher et al., 2012). Upon approval of the partial
        HIPAA waiver, pre-screening will take place through a phone questionnaire for subjects
        recruited through flyers and social media to assess for preliminary eligibility. The study
        will include the following phases: 1. Screening and recruiting 2. Initial therapy, baseline
        clinical measurements 3. Surgical therapy 4. Post-operative follow-up at 2-, 6-weeks 5.
        Clinical measurements at 6-months after surgery. Screening and recruiting: Upon consenting,
        screening will include gathering patient's personal information, medical history through
        questionnaires and clinical examination to confirm eligibility. Medical consultation with the
        patient's physician might be requested upon need. Initial therapy and clinical measurements:
        Following the screening examination, all subjects will receive a session of prophylaxis
        including instructions in proper oral hygiene measures. All clinical measurements at baseline
        and 6-months after surgery will be carried out by a calibrated examiner blinded to the
        provided treatment. Recession depth, and keratinized tissue height will be measured at the
        mid-buccal aspect of the treated tooth; probing depth, and clinical attachment level will be
        measured at the mesial, mid, and distal buccal/lingual aspect of the treated tooth; recession
        width will also be measured. Position of frenal attachment will be documented. All
        measurements will be performed by means of a PCP-15 manual periodontal probe and will be
        rounded up to the nearest millimeter. Recession depth will be measured as the distance
        between the cemento-enamel junction and gingival margin. Keratinized tissue height will be
        measured as the distance between the gingival margin and mucogingival junction. Intra-oral
        scanners will be used to capture scans at baseline and 6-months post-surgery. Randomization:
        Subjects will be assigned to one of the two treatment groups by blinded allocation.
        Randomization will be obtained with the use of computer-generated block randomization. The
        sealed envelope with treatment allocation will be assigned by the participant research number
        and opened at time of the surgery immediately before the treatment of the root surface.
        Surgical therapy: Under local anesthesia, a bilaminar (CAF+CTG) technique will be performed
        in the control group and a bilaminar (GPST+CTG) will be performed in the test group to
        accomplish root coverage. For CAF+CTG, in brief, exposed root surfaces will be mechanically
        treated with the use of curettes, a trapezoidal flap will be raised split/full thickness and
        a CTG will be sutured at the level of the cemento-enamel junction (CEJ). The flap will be
        coronally advanced and sutured with sling sutures anchored around the palatal cingulum of
        tooth with gingival recessions. For GPST+CTG, in brief, exposed root surfaces will be
        mechanically treated with the use of curettes. Starting from the line angle of the CEJ, a
        horizontal incision, whose length similar to the recession width, will be made distally or
        mesially. The distal point of the horizontal incision will be connected to a vertical
        incision which will be extended beyond the mucogingival junction (MGJ) and a split-thickness
        pedicle will be elevated. On the opposite side to the recession, a split-thickness tunnel
        will be prepared. CTG will be sutured at the level of CEJ with 1/3 of the length inserted
        into the prepared tunnel and the rest adapted to the recipient site. Finally, the pedicle
        will be rotated mesially to passively cover the middle portion of the graft and secured
        without tension. The CTG will be harvested from the palate using the single incision
        technique (Hurzeler and Weng 1999) or deepithelialized free gingival graft technique
        (Zucchelli et al 2010). The minimum thickness of CTG will be kept at 1.5 mm. Post-operative
        pain and edema will be controlled with ibuprofen 400 mg every 6-8 hours as needed. Patients
        will be instructed not to brush their teeth in the treated area but to rinse with
        chlorhexidine solution (0.12%) two times a day for 30 sec. for 6-weeks. Fourteen days after
        the surgical treatment, the sutures will be removed. Procedures done to ensure safety and
        minimize risks: The research team assembled have sufficient expertise and experience to
        conduct the research and will ensure that the projected sample size is sufficient to yield
        useful results. The surgical techniques being tested in this study are predictable procedures
        performed according to the current standards of care. The surgeries will be done by the
        residents of the Periodontics Department at CWRU, under strict supervision of a
        board-certified periodontist. Consequently, the delivery of standardized treatment of high
        quality will be ensured. In addition, the procedures will be performed conservatively with
        the aid of magnification and illumination to minimize the incidence of complications. The
        research team will meet regularly to evaluate the progress of the study, including periodic
        assessments of data quality and timelines, participant recruitment, accrual, and retention,
        and to ensure data integrity and confidentiality as well as adherence to the protocol
  
        For subjects who learn about the study through advertisements or social media that express
        their interest in participation, pre-screening will be done through phone questionnaires
        prior to the actual informed consent/screening visit. Individuals who were deemed eligible in
        the pre-screening phase, as well as subjects recruited from the department of Periodontics at
        CWRU will be scheduled for an in-person visit. During this visit, they will be presented with
        the informed consent forms which will be thoroughly reviewed with each participant in an
        estimated time of one hour. Subjects who request a waiting period between being informed and
        consenting will be given a period of 48 hours. Upon consenting, screening will take place in
        the same visit. Screening will include gathering information such as demographics, medical
        history, clinical examination, and inclusion/exclusion criteria assessment. Prophylaxis will
        take place in the same visit and oral hygiene instructions will be reinforced. Recruitment
        will continue in the same manner and will be concluded upon completion of the sample size in
        an estimated period of 24 months. In the subsequent visit, surgeries will be performed
        according to the randomized allocation provided by the software. After 2 weeks, subjects will
        be asked to come for a 2-week follow-up for suture removal and outcome measurements. At 6
        weeks and 6 months from the procedure, primary and secondary outcomes will be recorded again
        to enable comparing the changes from the baseline between the two surgical methods. The total
        timeline of the study is estimated to be around 36 months.
  
        Sample size: The study is powered to detect a minimum clinically significant difference in
        root coverage of 1 mm using alpha = 0.05, a power = 80%, a hypothesized within-group sigma of
        1 mm, obtained from previous studies. A total of 36 subjects will be recruited with an
        anticipated attrition of 20%. A minimum total of 30 subjects would be needed (15 test and 15
        control) for an anticipated power of 84%. Proposed Analysis: The D'Agostino & Pearson
        normality test will be applied for each variable to test for normality. Descriptive
        statistics will be used for demographics while continuous variables will be tested for normal
        distribution using parametric tests such as paired T-test or two-group Analysis of Variance
        (ANOVA) with repeated measures, with follow-up Tukey's Honestly Significant Difference (HSD)
        tests as appropriate. Non-parametric data will be tested using Kruskal-Wallis or Mann Whitney
        U test.
  allocation: Randomized
  intervention model: Single Group Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Percentage of mean root coverage
  time frame: 6 months
  description: The mean of the amount of root coverage will be calculated within and between test and control groups.
  measure: Percentage of complete root coverage
  time frame: 6 months
  description: The percentage of teeth that achieved complete root coverage will be compared between test and control.
  measure: Keratinized Tissue gain.
  time frame: 6 months
  description: The changes in the amount of keratinized tissue from baseline to 6 months will calculated within and between study groups
  arm group label: GPST + CTG
  arm group type: Experimental
  description: Gingival Pedicle Split Thickness + Connective Tissue Graft procedure
  arm group label: CAF + CTG
  arm group type: Active Comparator
  description: Coronally Advanced Flap + Connective Tissue Graft procedure
  intervention type: Procedure
  intervention name: Mandibular Incisor root coverage procedure
  description: Mucogingival procedure to cover mandibular incisor tooth with receded gums
  arm group label: CAF + CTG
  arm group label: GPST + CTG
  criteria: 
  gender: All
  minimum age: 18 Years
  maximum age: N/A
  healthy volunteers: Accepts Healthy Volunteers
  last name: Gian Pietro Schincaglia, DDS, PhD
  role: Principal Investigator
  affiliation: Case Western Reserve University
  last name: Gian Pietro Schincaglia, DDS,PhD
  phone: 2163684412
  email: gxs486@case.edu
  last name: Clara Sous
  phone: 2163684412
  email: cms395@case.edu
  facility: 
  status: Recruiting
  contact: 
  contact backup: 
  country: United States
  responsible party type: Principal Investigator
  investigator affiliation: Case Western Reserve University
  investigator full name: Gian Schincaglia
  investigator title: Professor, Chair and Graduate Program Director
  mesh term: Gingival Recession
  sharing ipd: No