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/NCT06020157</url>
    </required_header>
    <id_info>
      <org_study_id>Selcuk003</org_study_id>
      <nct_id>NCT06020157</nct_id>
    </id_info>
    <brief_title>Wound Healing Comparison of Simple and Continuous Suture Techniques in Oral Surgery</brief_title>
    <official_title>Wound Healing Comparison of Simple and Continuous Suture Techniques in Oral Surgery</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Selcuk University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Selcuk 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 study is aimed to compare two different suture techniques in terms of wound healing. In&#xD;
        this research, which is designed as an observational study, a comparison of simple and locked&#xD;
        continuous suture techniques will be done. For this purpose, Selçuk University Faculty of&#xD;
        Dentistry, Department of Oral and Maxillofacial Surgery, being treated at the full arch flap&#xD;
        opened (for alveoplasty). Half of the arch will be closed by simple suture, the other half&#xD;
        will be closed by continuous suture technique.&#xD;
  &#xD;
        It is planned to evaluate wound healing with the Landry Healing Index and Early Wound Healing&#xD;
        Score. It is planned to measure the amount of knot looseness in millimeters on the 7th day&#xD;
        when the sutures will be removed. On the 7th day, it is planned to evaluate the suture&#xD;
        removal pain for the patient and the ease of suture removal for the operator with the VAS&#xD;
        scale. Data collected from these assessments will be statistically compared for simple and&#xD;
        continuous sutures.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Not yet recruiting</overall_status>
    <start_date type="Anticipated">September 1, 2023</start_date>
    <completion_date type="Anticipated">December 1, 2023</completion_date>
    <primary_completion_date type="Anticipated">November 1, 2023</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>Single (Outcomes Assessor)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Laundry Healing Index-1</measure>
      <time_frame>Day 1</time_frame>
      <description>Scoring wound healing according to Laundry Healing Index(1 to 5; 1 is the best/5 is the worst)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Laundry Healing Index-3</measure>
      <time_frame>Day 3</time_frame>
      <description>Scoring wound healing according to Laundry Healing Index(1 to 5; 1 is the best/5 is the worst)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Laundry Healing Index-7</measure>
      <time_frame>Day 7</time_frame>
      <description>Scoring wound healing according to Laundry Healing Index(1 to 5; 1 is the best/5 is the worst)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Early Wound Healing Score-1</measure>
      <time_frame>Day 1</time_frame>
      <description>Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Early Wound Healing Score-3</measure>
      <time_frame>Day 3</time_frame>
      <description>Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Early Wound Healing Score-7</measure>
      <time_frame>Day 7</time_frame>
      <description>Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Suturing Time</measure>
      <time_frame>1 minutes after ending suture</time_frame>
      <description>The time between start and end of suture</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Knot Looseness</measure>
      <time_frame>Day 7</time_frame>
      <description>Measure loosening of the suture material</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain at Suture Removal</measure>
      <time_frame>Day 7</time_frame>
      <description>VAS scoring for pain at suture removal. The range of Scala is 0-10. A lower score means better results.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Suture Removal Difficulty</measure>
      <time_frame>Day 7</time_frame>
      <description>VAS scoring for suture removal difficulty. The range of Scala is 0-10. A lower score means better results.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">34</enrollment>
    <condition>Wound Heal</condition>
    <arm_group>
      <arm_group_label>Simple Suture Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <arm_group>
      <arm_group_label>Continuous Suture Group</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Simple Suture Technique</intervention_name>
      <description>The half of the full arch flap will be closed by the simple suture technique.</description>
      <arm_group_label>Simple Suture Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Continuous Suture Technique</intervention_name>
      <description>The half of the full arch flap will be closed by the continuous suture technique.</description>
      <arm_group_label>Continuous Suture Group</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Needing full arch alveoplasty&#xD;
  &#xD;
            -  No smoking&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Uncontrolled systemic condition&#xD;
  &#xD;
            -  Not participating in control appointments&#xD;
  &#xD;
            -  Complications about wound healing&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>40 Years</minimum_age>
      <maximum_age>65 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Şeyma Koyuncu</last_name>
      <role>Principal Investigator</role>
      <affiliation>Selcuk University, Faculty of Dentistry</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Gökhan Gürses</last_name>
      <phone>+905052595359</phone>
      <email>gokhangurses.akademik@gmail.com</email>
    </overall_contact>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 25, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 31, 2023</study_first_posted>
    <last_update_submitted>September 4, 2023</last_update_submitted>
    <last_update_submitted_qc>September 4, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Selcuk University</investigator_affiliation>
      <investigator_full_name>Gokhan Gurses</investigator_full_name>
      <investigator_title>Assistant Professor</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Wounds and Injuries</mesh_term>
    </condition_browse>
    <!-- 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/NCT06020157
  org study id: Selcuk003
  nct id: NCT06020157
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The study is aimed to compare two different suture techniques in terms of wound healing. In
        this research, which is designed as an observational study, a comparison of simple and locked
        continuous suture techniques will be done. For this purpose, Selçuk University Faculty of
        Dentistry, Department of Oral and Maxillofacial Surgery, being treated at the full arch flap
        opened (for alveoplasty). Half of the arch will be closed by simple suture, the other half
        will be closed by continuous suture technique.
  
        It is planned to evaluate wound healing with the Landry Healing Index and Early Wound Healing
        Score. It is planned to measure the amount of knot looseness in millimeters on the 7th day
        when the sutures will be removed. On the 7th day, it is planned to evaluate the suture
        removal pain for the patient and the ease of suture removal for the operator with the VAS
        scale. Data collected from these assessments will be statistically compared for simple and
        continuous sutures.
  allocation: Randomized
  intervention model: Parallel Assignment
  primary purpose: Treatment
  masking: Single (Outcomes Assessor)
  measure: Laundry Healing Index-1
  time frame: Day 1
  description: Scoring wound healing according to Laundry Healing Index(1 to 5; 1 is the best/5 is the worst)
  measure: Laundry Healing Index-3
  time frame: Day 3
  description: Scoring wound healing according to Laundry Healing Index(1 to 5; 1 is the best/5 is the worst)
  measure: Laundry Healing Index-7
  time frame: Day 7
  description: Scoring wound healing according to Laundry Healing Index(1 to 5; 1 is the best/5 is the worst)
  measure: Early Wound Healing Score-1
  time frame: Day 1
  description: Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)
  measure: Early Wound Healing Score-3
  time frame: Day 3
  description: Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)
  measure: Early Wound Healing Score-7
  time frame: Day 7
  description: Scoring wound healing according to Early Wound Healing Score(1 to 10; 1 is the best/10 is the worst)
  measure: Suturing Time
  time frame: 1 minutes after ending suture
  description: The time between start and end of suture
  measure: Knot Looseness
  time frame: Day 7
  description: Measure loosening of the suture material
  measure: Pain at Suture Removal
  time frame: Day 7
  description: VAS scoring for pain at suture removal. The range of Scala is 0-10. A lower score means better results.
  measure: Suture Removal Difficulty
  time frame: Day 7
  description: VAS scoring for suture removal difficulty. The range of Scala is 0-10. A lower score means better results.
  arm group label: Simple Suture Group
  arm group type: Experimental
  arm group label: Continuous Suture Group
  arm group type: Experimental
  intervention type: Other
  intervention name: Simple Suture Technique
  description: The half of the full arch flap will be closed by the simple suture technique.
  arm group label: Simple Suture Group
  intervention type: Other
  intervention name: Continuous Suture Technique
  description: The half of the full arch flap will be closed by the continuous suture technique.
  arm group label: Continuous Suture Group
  criteria: 
  gender: All
  minimum age: 40 Years
  maximum age: 65 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Şeyma Koyuncu
  role: Principal Investigator
  affiliation: Selcuk University, Faculty of Dentistry
  last name: Gökhan Gürses
  phone: +905052595359
  email: gokhangurses.akademik@gmail.com
  responsible party type: Principal Investigator
  investigator affiliation: Selcuk University
  investigator full name: Gokhan Gurses
  investigator title: Assistant Professor
  mesh term: Wounds and Injuries