<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/NCT04401826</url>
  </required_header>
  <id_info>
    <org_study_id>PER3-3-1</org_study_id>
    <nct_id>NCT04401826</nct_id>
  </id_info>
  <brief_title>Micro-surgical Treatment of Gummy Smile</brief_title>
  <official_title>Evaluation of Pain Following Microsurgical Esthetic Crown Lengthening Using Flap Vs. Flapless Piezo-surgical Approach: A Randomized Controlled Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</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>
      Compare pain response following microsurgical conventional flap approach using Piezosurgery&#xD;
      versus flapless approach for esthetic crown lengthening in management of patients with short&#xD;
      clinical crowns in the upper anterior region.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The conventional approach: Anesthesia will be given followed by bone sounding using William&#xD;
      graduated periodontal probe and measuring the pocket depth (using magnification loupes and&#xD;
      microsurgical blades)&#xD;
&#xD;
        -  Marking the bleeding points&#xD;
&#xD;
        -  An internal bevel incision is made followed afterwards by a sulcular incision.&#xD;
&#xD;
        -  The gingival collar is eliminated.&#xD;
&#xD;
        -  Elevation of the flap is proceeded to allow access for osteoplasty using piezo surgery&#xD;
           and an apical position of the bone 2-3mm beyond CEJ.&#xD;
&#xD;
        -  Mattress suture (6.0) is made&#xD;
&#xD;
      The intervention approach:&#xD;
&#xD;
      Surgery is done the same as in the conventional approach but without opening a flap, gaining&#xD;
      access via a tunneling instrument and piezo tips for osteoplasty&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 6, 2020</start_date>
  <completion_date type="Actual">June 6, 2022</completion_date>
  <primary_completion_date type="Actual">December 6, 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>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Pain VAS</measure>
    <time_frame>48 hours</time_frame>
    <description>Visual Analogue Scale for Pain (numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 days postoperative</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Mid-buccal gingival margin level</measure>
    <time_frame>6 months</time_frame>
    <description>Periodontal probe with William's graduation will be used to measure the distance from a prefabricated grooved stent vertically- to the level of the gingival margin at the mid-buccal surface (measured at baseline, 3 and 6 months postoperatively)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Surgical Patient Satisfaction.</measure>
    <time_frame>6 months</time_frame>
    <description>Numerical Rating Scale (A 3-item questionnaire is asked, and the patients shall use a 7-point answer scale. )</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Pink Esthetic Score</measure>
    <time_frame>6 months</time_frame>
    <description>The PES is based on seven variables:&#xD;
mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable shall be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The mesial and distal papilla will be evaluated for completeness, incompleteness or absence. All other variables will be assessed by comparison to a reference tooth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Surgical swelling</measure>
    <time_frame>14 days</time_frame>
    <description>Absent: no swelling, Slight: intraoral swelling at the operated area, Moderate: moderate intraoral swelling at the operated area and Intense: intensive extra oral swelling extending beyond the operated area. (Assessed in day 7 and 14 postoperatively)</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">24</enrollment>
  <condition>Pain, Postoperative</condition>
  <arm_group>
    <arm_group_label>The conventional approach</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Conventionnal ECL using piezosurgery and microsurgical tools</description>
  </arm_group>
  <arm_group>
    <arm_group_label>The intervention approach:</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Conventionnal ECL with tunneling using piezosurgery and microsurgical tools</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Tunneling micro-surgical crown lengthening approach using piezo-surgery</intervention_name>
    <description>excess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery via tunneling</description>
    <arm_group_label>The intervention approach:</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Micro-surgical crown lengthening approach using Piezosurgery</intervention_name>
    <description>excess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery with conventional flap elevation.</description>
    <arm_group_label>The conventional approach</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients with healthy systemic condition.&#xD;
&#xD;
          2. Adult patients ˃ 18 years old.&#xD;
&#xD;
          3. The presence of the six upper anterior teeth.&#xD;
&#xD;
          4. Patients who have short clinical crowns due to altered passive eruption classified as&#xD;
             Type I subclass B (Coslet, Vanarsdall and Weisgold, 1977).&#xD;
&#xD;
          5. Absence of sites with attachment loss and probing depth (PD) &gt;3 mm.&#xD;
&#xD;
          6. Keratinized gingiva of at least 2mm width (Pontoriero and Carnevale, 2001).&#xD;
&#xD;
          7. Compliance with good oral hygiene.&#xD;
&#xD;
          8. Patients accepts 6-months follow-up period (cooperative patients).&#xD;
&#xD;
          9. Patients provides an informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Presence of prosthetic crowns&#xD;
&#xD;
          2. Extensive restorations&#xD;
&#xD;
          3. Extensive incisal edge attrition.&#xD;
&#xD;
          4. Smokers ˃ 10 cigarettes / day&#xD;
&#xD;
          5. Pregnant females&#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>
  <location>
    <facility>
      <name>Faculty of Oral and Dental Medecine-CU</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <verification_date>July 2023</verification_date>
  <study_first_submitted>May 21, 2020</study_first_submitted>
  <study_first_submitted_qc>May 22, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">May 26, 2020</study_first_posted>
  <last_update_submitted>July 3, 2023</last_update_submitted>
  <last_update_submitted_qc>July 3, 2023</last_update_submitted_qc>
  <last_update_posted type="Actual">July 5, 2023</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Marie-line Sherif Sourour</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Pain, Postoperative</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- Results have not yet been posted for this study                                          -->
</clinical_study>


download date: ClinicalTrials.gov processed this data on September 20, 2023
link text: Link to the current ClinicalTrials.gov record.
url: https://clinicaltrials.gov/ct2/show/NCT04401826
org study id: PER3-3-1
nct id: NCT04401826
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
Compare pain response following microsurgical conventional flap approach using Piezosurgery
      versus flapless approach for esthetic crown lengthening in management of patients with short
      clinical crowns in the upper anterior region.
The conventional approach: Anesthesia will be given followed by bone sounding using William
      graduated periodontal probe and measuring the pocket depth (using magnification loupes and
      microsurgical blades)

        -  Marking the bleeding points

        -  An internal bevel incision is made followed afterwards by a sulcular incision.

        -  The gingival collar is eliminated.

        -  Elevation of the flap is proceeded to allow access for osteoplasty using piezo surgery
           and an apical position of the bone 2-3mm beyond CEJ.

        -  Mattress suture (6.0) is made

      The intervention approach:

      Surgery is done the same as in the conventional approach but without opening a flap, gaining
      access via a tunneling instrument and piezo tips for osteoplasty
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Pain VAS
time frame: 48 hours
description: Visual Analogue Scale for Pain (numbers from 0 to 10 ('no pain' to 'worst pain imaginable') measured daily for the first 2 days postoperative
measure: Mid-buccal gingival margin level
time frame: 6 months
description: Periodontal probe with William's graduation will be used to measure the distance from a prefabricated grooved stent vertically- to the level of the gingival margin at the mid-buccal surface (measured at baseline, 3 and 6 months postoperatively)
measure: Post-Surgical Patient Satisfaction.
time frame: 6 months
description: Numerical Rating Scale (A 3-item questionnaire is asked, and the patients shall use a 7-point answer scale. )
measure: Pink Esthetic Score
time frame: 6 months
description: The PES is based on seven variables:
mesial papilla, distal papilla, soft-tissue level, soft tissue contour, alveolar process deficiency, soft-tissue color and texture. Each variable shall be assessed with a 2-1-0 score, with 2 being the best and 0 being the poorest score. The mesial and distal papilla will be evaluated for completeness, incompleteness or absence. All other variables will be assessed by comparison to a reference tooth.
measure: Post-Surgical swelling
time frame: 14 days
description: Absent: no swelling, Slight: intraoral swelling at the operated area, Moderate: moderate intraoral swelling at the operated area and Intense: intensive extra oral swelling extending beyond the operated area. (Assessed in day 7 and 14 postoperatively)
arm group label: The conventional approach
arm group type: Experimental
description: Conventionnal ECL using piezosurgery and microsurgical tools
arm group label: The intervention approach:
arm group type: Active Comparator
description: Conventionnal ECL with tunneling using piezosurgery and microsurgical tools
intervention type: Procedure
intervention name: Tunneling micro-surgical crown lengthening approach using piezo-surgery
description: excess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery via tunneling
arm group label: The intervention approach:
intervention type: Procedure
intervention name: Micro-surgical crown lengthening approach using Piezosurgery
description: excess gingiva is eliminated. 2 mm bone is removed from CEJ-bone crest with piezo surgery with conventional flap elevation.
arm group label: The conventional approach
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: Egypt
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Marie-line Sherif Sourour
investigator title: Principal Investigator
mesh term: Pain, Postoperative
sharing ipd: No