<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/NCT03804281</url>
  </required_header>
  <id_info>
    <org_study_id>Dentaris192018</org_study_id>
    <nct_id>NCT03804281</nct_id>
  </id_info>
  <brief_title>Clinical Evaluation of Conventional Versus Microsurgical Techniques of Esthetic Crown Lengthening</brief_title>
  <official_title>Clinical Evaluation of Gingival Margin Stability Following Conventional Versus Microsurgical Techniques of Esthetic Crown Lengthening</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>
      the study compare gingival margin stability following conventional approach versus&#xD;
      microsurgical approach of esthetic crown lengthening in management of patients with short&#xD;
      clinical crowns in the upper anterior region.In management of patients with short clinical&#xD;
      crowns in the upper anterior region, there is no difference in gingival margin stability&#xD;
      between conventional and microsurgical approaches of esthetic crown lengthening.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">August 1, 2020</completion_date>
  <primary_completion_date type="Anticipated">January 1, 2020</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>None (Open Label)</masking>
  </study_design_info>
  <primary_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 the CEJ to the gingival margin at the mid-buccal surface</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Pink Esthetic Score (PES)</measure>
    <time_frame>6 months</time_frame>
    <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</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Surgical swelling</measure>
    <time_frame>7days</time_frame>
    <description>will be evaluated post-surgically with Verbal Rating Scale with words ranging from (absent-slight-moderate-intense) 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).</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Post-Surgical Patient Satisfaction: 3-item questionnaire</measure>
    <time_frame>6 months</time_frame>
    <description>A 3-item questionnaire is asked and the patients shall use a 7-point answer scale</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">24</enrollment>
  <condition>Gummy Smile</condition>
  <arm_group>
    <arm_group_label>Test group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>esthetic crown lengthening with microsurgical approach</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>esthetic crown lengthening with conventional approach.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Test group</intervention_name>
    <description>The surgery will be done with the use of 4x magnification loop, the knives are micro blades and micro-sutures 7//0 used with the microsurgical instruments kit</description>
    <arm_group_label>Test group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Control group</intervention_name>
    <description>esthetic crown lengthening with conventional approach with an internal bevel incision, following CEJ anatomy, this will be followed by an intra-sulcular incision, removal of the strip of outlined marginal gingiva and elevation of a mucoperiosteal ﬂap to the level of the alveolar bone crest.</description>
    <arm_group_label>Control group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients with healthy systemic condition.&#xD;
&#xD;
          -  Adult patients ˃ 18 years old.&#xD;
&#xD;
          -  The presence of the six upper anterior teeth.&#xD;
&#xD;
          -  Absence of sites with attachment loss and probing depth (PD) &gt;3 mm&#xD;
&#xD;
          -  Keratinized gingiva of at least 2mm width.&#xD;
&#xD;
          -  Compliance with good oral hygiene.&#xD;
&#xD;
          -  Patients accepts 6-months follow-up period (cooperative patients).&#xD;
&#xD;
          -  Patients provides an informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Gummy smile with normal tooth proportions&#xD;
&#xD;
          -  Presence of prosthetic crowns&#xD;
&#xD;
          -  Extensive restorations&#xD;
&#xD;
          -  Extensive incisal edge attrition.&#xD;
&#xD;
          -  Misalignment on maxillary anterior teeth.&#xD;
&#xD;
          -  Smokers ˃ 10 cigarettes / day.&#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>
  <verification_date>January 2019</verification_date>
  <study_first_submitted>January 11, 2019</study_first_submitted>
  <study_first_submitted_qc>January 14, 2019</study_first_submitted_qc>
  <study_first_posted type="Actual">January 15, 2019</study_first_posted>
  <last_update_submitted>January 16, 2019</last_update_submitted>
  <last_update_submitted_qc>January 16, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">January 18, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Mohamed elshafie mohamed tawfiq hassan</investigator_full_name>
    <investigator_title>Dentist</investigator_title>
  </responsible_party>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03804281
org study id: Dentaris192018
nct id: NCT03804281
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
the study compare gingival margin stability following conventional approach versus
      microsurgical approach of esthetic crown lengthening in management of patients with short
      clinical crowns in the upper anterior region.In management of patients with short clinical
      crowns in the upper anterior region, there is no difference in gingival margin stability
      between conventional and microsurgical approaches of esthetic crown lengthening.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
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 the CEJ to the gingival margin at the mid-buccal surface
measure: Pink Esthetic Score (PES)
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
measure: Post-Surgical swelling
time frame: 7days
description: will be evaluated post-surgically with Verbal Rating Scale with words ranging from (absent-slight-moderate-intense) 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).
measure: Post-Surgical Patient Satisfaction: 3-item questionnaire
time frame: 6 months
description: A 3-item questionnaire is asked and the patients shall use a 7-point answer scale
arm group label: Test group
arm group type: Experimental
description: esthetic crown lengthening with microsurgical approach
arm group label: Control group
arm group type: Active Comparator
description: esthetic crown lengthening with conventional approach.
intervention type: Procedure
intervention name: Test group
description: The surgery will be done with the use of 4x magnification loop, the knives are micro blades and micro-sutures 7//0 used with the microsurgical instruments kit
arm group label: Test group
intervention type: Procedure
intervention name: Control group
description: esthetic crown lengthening with conventional approach with an internal bevel incision, following CEJ anatomy, this will be followed by an intra-sulcular incision, removal of the strip of outlined marginal gingiva and elevation of a mucoperiosteal ﬂap to the level of the alveolar bone crest.
arm group label: Control group
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Mohamed elshafie mohamed tawfiq hassan
investigator title: Dentist
sharing ipd: Undecided