<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/NCT03753906</url>
  </required_header>
  <id_info>
    <org_study_id>02_D012_71909</org_study_id>
    <nct_id>NCT03753906</nct_id>
  </id_info>
  <brief_title>Evaluation of Self-filling Osmotic Tissue Expander in Augmenting Keratinized Tissue Around Dentulous Region</brief_title>
  <official_title>Clinical and Optical Evaluation of Self-filling Osmotic Tissue Expander in Augmenting Keratinized Tissue Around Dentulous Region</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Krishnadevaraya College of Dental Sciences &amp; Hospital</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Krishnadevaraya College of Dental Sciences &amp; Hospital</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>Yes</is_fda_regulated_device>
    <is_us_export>No</is_us_export>
  </oversight_info>
  <brief_summary>
    <textblock>
      The present study is a human, prospective, single centre, single blind randomised controlled&#xD;
      clinical tria conducted to explore the feasibility and efficacy of self-inflating hydrogel&#xD;
      expander (Osmed®) to gain keratinised tissue around the dentulous area. The trial is in&#xD;
      accordance to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Ten healthy individuals satisfying the inclusion and exclusion criteria were recruited for&#xD;
      the study. A detailed, thorough medical and dental history was obtained and each patient was&#xD;
      subjected to comprehensive clinical and radiological examination. All patients were informed&#xD;
      about the nature of the study, surgical procedure involved, potential benefits and risks&#xD;
      associated with the surgical procedure and a written informed consent was obtained from all&#xD;
      patients.&#xD;
&#xD;
      All the patients were implanted with self-inflating hydrogel expander (Osmed®) in&#xD;
      subperiosteal positions using the pouch technique in the mandibular anterior region. The&#xD;
      clinical parameters were recorded at baseline, two weeks post expander retrieval, three&#xD;
      months and six months post-operatively.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 5, 2016</start_date>
  <completion_date type="Actual">January 2019</completion_date>
  <primary_completion_date type="Actual">July 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>N/A</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <intervention_model_description>All the patients were implanted with self-inflating hydrogel expander in subperiosteal positions using the pouch technique in the mandibular anterior region.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Keratinized tissue width (KTW)</measure>
    <time_frame>6 months</time_frame>
    <description>measured from the most apical gingival margin to the mucogingival junction (MGJ), with the MGJ location determined using the visual method (Schiller's potassium iodide solution).</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Keratinized tissue thickness (KTT)</measure>
    <time_frame>6 months</time_frame>
    <description>measured at the mid-buccal aspect of the study tooth just below the marginal gingiva using an endodontic file.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Optical scanning for analysis of tissue thickness</measure>
    <time_frame>6 months</time_frame>
    <description>alginate impressions were made at the baseline prior to expander placement, immediately after the removal of expander and 6 months post-augmentation. The prepared casts were assessed for soft tissue changes by optical scan using 3D camera (Intellidenta AG, Basel, Switzerland). The obtained digital images of the casts reflecting the different treatment time were then superimposed and matched in one common coordinate system. The buccal surfaces of the study teeth were used as a reference point for the superimposition of different images. Subsequently, a defined area of interest at each site were measured and the difference in the linear distance between the time points were calculated.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Gingival recession depth (GRD)</measure>
    <time_frame>6 months</time_frame>
    <description>measured at the mid-buccal aspect of the study tooth from the CEJ to the most apical extension of gingival margin (using UNC-15 probe)</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Vestibular depth (VD)</measure>
    <time_frame>6 months</time_frame>
    <description>measured from cemento-enamel junction (CEJ) to the deepest part of vestibular mucosa. Measurements were taken with the UNC-15 probe while exerting a firm facial pull on the lip or cheek at a 90° angle to the surface of the teeth.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Color and texture match to the surrounding tissue</measure>
    <time_frame>6 months</time_frame>
    <description>binary ratings of &quot;equal or not equal to surrounding native tissue&quot; assigned upon clinical examination</description>
  </secondary_outcome>
  <number_of_arms>1</number_of_arms>
  <enrollment type="Actual">10</enrollment>
  <condition>Soft Tissue Augmentation</condition>
  <arm_group>
    <arm_group_label>Osmed® hydrogel expander implantation</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Implantation of Osmed® hydrogel expander was done in subperiosteal positions using the pouch technique in the mandibular anterior region.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Osmed® hydrogel expander implantation</intervention_name>
    <description>Under local anaesthesia, a small vertical incision, adapted to the diameter of the Osmed® sself-inflating hydrogel expander, was made with #15 scalpel blade at the mesial line angle of the adjacent tooth which started below the gingival margin extending from the keratinized tissue above the MGJ to the non-keratinized tissue beyond the MGJ. A minimally invasive preparation of a subperiosteal pouch was performed with KPA tunnelling knife. Size of the pouch was controlled with the specific surgical template to ensure the device easily fits into the prepared pouch without tension. Expanders were secured in the correct position with a bone fixation screw, at the flat end, which does not possess an expansion capability. The wound was closed with 3-0 silk suture using simple interrupted sutures.</description>
    <arm_group_label>Osmed® hydrogel expander implantation</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients willing to participate in the study&#xD;
&#xD;
          -  Patients above 18 years of age&#xD;
&#xD;
          -  Systemically healthy patients&#xD;
&#xD;
          -  Patients exhibiting keratinized tissue width &lt; 2 mm&#xD;
&#xD;
          -  Patients manifesting Miller's Class I or Class II recession&#xD;
&#xD;
          -  Patients who demonstrate good plaque control ( PI &lt; 10% ) and showing good compliance&#xD;
&#xD;
          -  Uncompromised adjacent teeth with healthy gingival conditions&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Untreated periodontal disease, caries&#xD;
&#xD;
          -  Insufficient oral hygiene&#xD;
&#xD;
          -  Thin biotype ( &lt; 0.8 mm )&#xD;
&#xD;
          -  Use of tobacco&#xD;
&#xD;
          -  Previous radiation therapy&#xD;
&#xD;
          -  Patients with known systemic diseases and conditions as uncontrolled diabetes mellitus&#xD;
             or haemorrhagic disorders&#xD;
&#xD;
          -  Pregnant and lactating women&#xD;
&#xD;
          -  Non-compliant patients&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Dr. Prabhuji MLV, MDS</last_name>
    <role>Study Director</role>
    <affiliation>Krishnadevaraya College of Dental Sciences</affiliation>
  </overall_official>
  <verification_date>February 2019</verification_date>
  <study_first_submitted>November 21, 2018</study_first_submitted>
  <study_first_submitted_qc>November 23, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">November 27, 2018</study_first_posted>
  <last_update_submitted>February 27, 2019</last_update_submitted>
  <last_update_submitted_qc>February 27, 2019</last_update_submitted_qc>
  <last_update_posted type="Actual">March 1, 2019</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <!-- 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/NCT03753906
org study id: 02_D012_71909
nct id: NCT03753906
lead sponsor: 
is fda regulated drug: No
is fda regulated device: Yes
is us export: No
The present study is a human, prospective, single centre, single blind randomised controlled
      clinical tria conducted to explore the feasibility and efficacy of self-inflating hydrogel
      expander (Osmed®) to gain keratinised tissue around the dentulous area. The trial is in
      accordance to the Consolidated Standards of Reporting Trials (CONSORT) criteria, 2010.
Ten healthy individuals satisfying the inclusion and exclusion criteria were recruited for
      the study. A detailed, thorough medical and dental history was obtained and each patient was
      subjected to comprehensive clinical and radiological examination. All patients were informed
      about the nature of the study, surgical procedure involved, potential benefits and risks
      associated with the surgical procedure and a written informed consent was obtained from all
      patients.

      All the patients were implanted with self-inflating hydrogel expander (Osmed®) in
      subperiosteal positions using the pouch technique in the mandibular anterior region. The
      clinical parameters were recorded at baseline, two weeks post expander retrieval, three
      months and six months post-operatively.
allocation: N/A
intervention model: Single Group Assignment
intervention model description: All the patients were implanted with self-inflating hydrogel expander in subperiosteal positions using the pouch technique in the mandibular anterior region.
primary purpose: Treatment
masking: None (Open Label)
measure: Keratinized tissue width (KTW)
time frame: 6 months
description: measured from the most apical gingival margin to the mucogingival junction (MGJ), with the MGJ location determined using the visual method (Schiller's potassium iodide solution).
measure: Keratinized tissue thickness (KTT)
time frame: 6 months
description: measured at the mid-buccal aspect of the study tooth just below the marginal gingiva using an endodontic file.
measure: Optical scanning for analysis of tissue thickness
time frame: 6 months
description: alginate impressions were made at the baseline prior to expander placement, immediately after the removal of expander and 6 months post-augmentation. The prepared casts were assessed for soft tissue changes by optical scan using 3D camera (Intellidenta AG, Basel, Switzerland). The obtained digital images of the casts reflecting the different treatment time were then superimposed and matched in one common coordinate system. The buccal surfaces of the study teeth were used as a reference point for the superimposition of different images. Subsequently, a defined area of interest at each site were measured and the difference in the linear distance between the time points were calculated.
measure: Gingival recession depth (GRD)
time frame: 6 months
description: measured at the mid-buccal aspect of the study tooth from the CEJ to the most apical extension of gingival margin (using UNC-15 probe)
measure: Vestibular depth (VD)
time frame: 6 months
description: measured from cemento-enamel junction (CEJ) to the deepest part of vestibular mucosa. Measurements were taken with the UNC-15 probe while exerting a firm facial pull on the lip or cheek at a 90° angle to the surface of the teeth.
measure: Color and texture match to the surrounding tissue
time frame: 6 months
description: binary ratings of "equal or not equal to surrounding native tissue" assigned upon clinical examination
arm group label: Osmed® hydrogel expander implantation
arm group type: Experimental
description: Implantation of Osmed® hydrogel expander was done in subperiosteal positions using the pouch technique in the mandibular anterior region.
intervention type: Device
intervention name: Osmed® hydrogel expander implantation
description: Under local anaesthesia, a small vertical incision, adapted to the diameter of the Osmed® sself-inflating hydrogel expander, was made with #15 scalpel blade at the mesial line angle of the adjacent tooth which started below the gingival margin extending from the keratinized tissue above the MGJ to the non-keratinized tissue beyond the MGJ. A minimally invasive preparation of a subperiosteal pouch was performed with KPA tunnelling knife. Size of the pouch was controlled with the specific surgical template to ensure the device easily fits into the prepared pouch without tension. Expanders were secured in the correct position with a bone fixation screw, at the flat end, which does not possess an expansion capability. The wound was closed with 3-0 silk suture using simple interrupted sutures.
arm group label: Osmed® hydrogel expander implantation
criteria: 
gender: All
minimum age: 18 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Dr. Prabhuji MLV, MDS
role: Study Director
affiliation: Krishnadevaraya College of Dental Sciences
responsible party type: Sponsor