<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/NCT03774888</url>
  </required_header>
  <id_info>
    <org_study_id>IRB-300002688</org_study_id>
    <nct_id>NCT03774888</nct_id>
  </id_info>
  <brief_title>To Compare Different Soft Tissue Grafts at the Time of Lateral Ridge Augmentation Procedure.</brief_title>
  <official_title>A Randomized Controlled Trial to Compare the Histomorphometric and Clinical Outcomes of Soft Tissue Augmentation at the Time of Lateral Ridge Augmentation Procedures</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Alabama at Birmingham</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Alabama at Birmingham</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>
      This study will compare two commonly used soft tissue grafting techniques (connective tissue&#xD;
      graft, CTG vs Acellular Dermal Matrix, ADM) to augment the soft tissue at the time of lateral&#xD;
      ridge augmentation procedure.&#xD;
&#xD;
      Following ridge augmentation procedure, most of the times there is a need for soft tissue&#xD;
      augmentation to change the quality of the tissue around future implant's site. To our&#xD;
      knowledge, the influence of soft tissue augmentation at the time of ridge augmentation&#xD;
      procedure has not been tested defects.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Research data and daily clinical observations reveal that implants with lack of surrounding&#xD;
      keratinized mucosa KM (gingiva-like tissue that normally surrounds natural teeth) are more&#xD;
      prone to persistent gingival inflammation, faster disease progression and compromised plaque&#xD;
      control. Ridge augmentation procedure can alter the quality of tissue in the sites where it&#xD;
      will receive dental implants. Soft tissue grating aims at changing the nature of peri-implant&#xD;
      soft tissue by creating or increasing the zone of keratinized mucosa (KM) surrounding&#xD;
      implants. CTG or ADM will be grafted at the same time of lateral ridge augmentation&#xD;
      procedure.&#xD;
&#xD;
      Specific aims for this project include the evaluation of:&#xD;
&#xD;
        1. To evaluate the quality of soft tissue regenerated with the use of the two available&#xD;
           soft tissue grafts via histological analysis.&#xD;
&#xD;
        2. To evaluate whether CTG or ADM influences the outcomes of Guided Bone Regeneration (GBR)&#xD;
           procedures.&#xD;
&#xD;
        3. To quantify the soft tissue augmentation achieved by the two available soft tissue&#xD;
           grafts by direct clinical measurements after the healing&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Active, not recruiting</overall_status>
  <start_date type="Actual">October 3, 2019</start_date>
  <completion_date type="Anticipated">November 2023</completion_date>
  <primary_completion_date type="Actual">May 10, 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>None (Open Label)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>quality of soft tissue regenerated</measure>
    <time_frame>From baseline to 6 months</time_frame>
    <description>Compare the increase in soft tissue quality (attached or keratinized ) between two commonly used soft tissue grafts</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Any influence on the soft tissue outcomes</measure>
    <time_frame>From baseline to 6 months</time_frame>
    <description>Compare the amount of bone graft gained when either soft tissue grafts added</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Measure changes in tissue thickness (in mm) between ADM and CTG</measure>
    <time_frame>: From baseline to 6 months</time_frame>
    <description>Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between CTG and ADM following soft tissue grafting.</description>
  </primary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">27</enrollment>
  <condition>Bone Graft; Complications, Infection or Inflammation</condition>
  <condition>Ridge Deficency</condition>
  <condition>Dental Implant</condition>
  <arm_group>
    <arm_group_label>connective tissue graft</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Connective tissue grafting (CTG) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Acellular Dermal Matrix</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Acellular Dermal matrix (ADM) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft</description>
  </arm_group>
  <arm_group>
    <arm_group_label>No soft tissue graft</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>Control group where no soft tissue graft is added to the lateral ridge augmentation.Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Connective tissue graft at time of bone graft</intervention_name>
    <description>following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft</description>
    <arm_group_label>connective tissue graft</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Acellular Demal Matrix at time of bone graft</intervention_name>
    <description>following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft</description>
    <arm_group_label>Acellular Dermal Matrix</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>No soft tissue grafting at time of bone graft</intervention_name>
    <description>Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added.</description>
    <arm_group_label>No soft tissue graft</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Be a registered University of Alabama at Birmingham (UAB) dental school patient&#xD;
&#xD;
          2. English Speaking&#xD;
&#xD;
          3. Healthy enough to undergo the proposed therapy&#xD;
&#xD;
          4. Demonstrated willingness to comply with study directions and time-line&#xD;
&#xD;
          5. Insufficient alveolar ridge width for endosseous implant placement defined as 5mm or&#xD;
             less as determined by bone sounding and cone beam computed tomography (CBCT) scan.&#xD;
&#xD;
          6. Able to read and understand the informed consent form&#xD;
&#xD;
          7. Need for implants to replace missing tooth or teeth in at least one quadrant of the&#xD;
             mouth.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. No English Speaking&#xD;
&#xD;
          2. Smokers/ tobacco users (&gt;10 cigarettes a day)&#xD;
&#xD;
          3. Less than 18 years old&#xD;
&#xD;
          4. Know hypersensitivity to titanium&#xD;
&#xD;
          5. Patients with significant medical conditions or habbits expected to interfere with&#xD;
             bony healing.&#xD;
&#xD;
          6. Patient is a poor compliance risk (i.e., poor oral hygiene, history of alcohol or drug&#xD;
             abuse)&#xD;
&#xD;
          7. Bone dehiscence of &gt;4mm following tooth extraction or Vertical loss of bone at&#xD;
             edentulous ridge&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>99 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Hussein Basma, DDS, MS</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Alabama at Birmingham</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Unversity of Alabama at Birmingham, School of Dentistry</name>
      <address>
        <city>Birmingham</city>
        <state>Alabama</state>
        <zip>35294-0007</zip>
        <country>United States</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>United States</country>
  </location_countries>
  <verification_date>December 2022</verification_date>
  <study_first_submitted>December 11, 2018</study_first_submitted>
  <study_first_submitted_qc>December 11, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 13, 2018</study_first_posted>
  <last_update_submitted>December 7, 2022</last_update_submitted>
  <last_update_submitted_qc>December 7, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">December 8, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>University of Alabama at Birmingham</investigator_affiliation>
    <investigator_full_name>Hussein Basma</investigator_full_name>
    <investigator_title>Principal Investigator</investigator_title>
  </responsible_party>
  <keyword>Keratinized Tissue</keyword>
  <keyword>Keratinized mucosa</keyword>
  <keyword>attached mucosa</keyword>
  <keyword>dental implants</keyword>
  <keyword>ridge augmentation</keyword>
  <keyword>guided bone regeneration</keyword>
  <keyword>connective tissue graft</keyword>
  <keyword>acellular demral matrix</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Inflammation</mesh_term>
  </condition_browse>
  <!-- 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/NCT03774888
org study id: IRB-300002688
nct id: NCT03774888
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study will compare two commonly used soft tissue grafting techniques (connective tissue
      graft, CTG vs Acellular Dermal Matrix, ADM) to augment the soft tissue at the time of lateral
      ridge augmentation procedure.

      Following ridge augmentation procedure, most of the times there is a need for soft tissue
      augmentation to change the quality of the tissue around future implant's site. To our
      knowledge, the influence of soft tissue augmentation at the time of ridge augmentation
      procedure has not been tested defects.
Research data and daily clinical observations reveal that implants with lack of surrounding
      keratinized mucosa KM (gingiva-like tissue that normally surrounds natural teeth) are more
      prone to persistent gingival inflammation, faster disease progression and compromised plaque
      control. Ridge augmentation procedure can alter the quality of tissue in the sites where it
      will receive dental implants. Soft tissue grating aims at changing the nature of peri-implant
      soft tissue by creating or increasing the zone of keratinized mucosa (KM) surrounding
      implants. CTG or ADM will be grafted at the same time of lateral ridge augmentation
      procedure.

      Specific aims for this project include the evaluation of:

        1. To evaluate the quality of soft tissue regenerated with the use of the two available
           soft tissue grafts via histological analysis.

        2. To evaluate whether CTG or ADM influences the outcomes of Guided Bone Regeneration (GBR)
           procedures.

        3. To quantify the soft tissue augmentation achieved by the two available soft tissue
           grafts by direct clinical measurements after the healing
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: None (Open Label)
measure: quality of soft tissue regenerated
time frame: From baseline to 6 months
description: Compare the increase in soft tissue quality (attached or keratinized ) between two commonly used soft tissue grafts
measure: Any influence on the soft tissue outcomes
time frame: From baseline to 6 months
description: Compare the amount of bone graft gained when either soft tissue grafts added
measure: Measure changes in tissue thickness (in mm) between ADM and CTG
time frame: : From baseline to 6 months
description: Using a periodontal probe, soft tissue thickness will be measured (in mm) and compared between CTG and ADM following soft tissue grafting.
arm group label: connective tissue graft
arm group type: Experimental
description: Connective tissue grafting (CTG) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft
arm group label: Acellular Dermal Matrix
arm group type: Experimental
description: Acellular Dermal matrix (ADM) will be placed at the time of lateral ridge augmentation.Following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft
arm group label: No soft tissue graft
arm group type: Active Comparator
description: Control group where no soft tissue graft is added to the lateral ridge augmentation.Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added.
intervention type: Procedure
intervention name: Connective tissue graft at time of bone graft
description: following the placement of the bone graft and the membrane, a CTG will be harvested and sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft
arm group label: connective tissue graft
intervention type: Procedure
intervention name: Acellular Demal Matrix at time of bone graft
description: following the placement of the bone graft and the membrane, an ADM will be sutured to the membrane and then the flaps passively sutured on top on the bone and soft tissue graft
arm group label: Acellular Dermal Matrix
intervention type: Procedure
intervention name: No soft tissue grafting at time of bone graft
description: Following the placement of the bone graft and the membrane, the flaps passively sutured on top on the bone. No soft tissue graft will be added.
arm group label: No soft tissue graft
criteria: 
gender: All
minimum age: 18 Years
maximum age: 99 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Hussein Basma, DDS, MS
role: Principal Investigator
affiliation: University of Alabama at Birmingham
facility: 
country: United States
responsible party type: Principal Investigator
investigator affiliation: University of Alabama at Birmingham
investigator full name: Hussein Basma
investigator title: Principal Investigator
mesh term: Inflammation