<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/NCT03003624</url>
  </required_header>
  <id_info>
    <org_study_id>SVSIEC</org_study_id>
    <nct_id>NCT03003624</nct_id>
  </id_info>
  <brief_title>Comparing the Outcomes of Incisions Made by Colorado® Microdissection Needle</brief_title>
  <official_title>Comparing the Outcomes Of Incisions Made By Colorado® Microdissection Needle, Electrosurgery Tip And Surgical Blade During Periodontal Surgery</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>SVS Institute of Dental Sciences</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>SVS Institute of Dental Sciences</source>
  <oversight_info>
    <has_dmc>Yes</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study was to compare the outcomes of incisions made by Colorado®&#xD;
      microdissection needle, electrosurgery tip and surgical blade during periodontal surgery.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Commercially, many microdissection needle systems are available, such as Stryker Colorado®&#xD;
      microdissection needle (CMN) (Stryker-Leibinger, Freiburg, Germany) and optimicro™&#xD;
      microdissection needles. Colorado® microdissection needle (CMN) combine the advantages of&#xD;
      scalpel and electrosurgery. CMN® was introduced into clinical practice in 1997, with a wide&#xD;
      array of applications in the field of Ophthalmology, Neurosurgery, and others.&#xD;
&#xD;
      The primary feature of the Colorado® microdissection needle is the ultra-sharp tungsten tip&#xD;
      that delivers the wave-form from the electrosurgery generator to a very small spot. This&#xD;
      allows the use of extremely low wattages, resulting in less tissue necrosis, precision&#xD;
      cutting and cautery, and less post-operative pain. The instrument tip is a delicately&#xD;
      machined, insulated tungsten diathermy needle that is compatible with any standard cautery&#xD;
      hand piece. Tungsten, with its extremely high melting point (&gt;3400°C) provides a heat&#xD;
      resistant tip that maintains sharpness compared to stainless steel tips that dull rapidly.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>March 2015</start_date>
  <completion_date type="Actual">August 2016</completion_date>
  <primary_completion_date type="Actual">March 2016</primary_completion_date>
  <phase>Phase 3</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, Care Provider, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Quantity of blood loss in ml</measure>
    <time_frame>Immediate postoperative volume</time_frame>
    <description>Quantity of blood loss by swab weighing method.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>PPD in mm</measure>
    <time_frame>Baseline to 180 days</time_frame>
    <description>Probing pocket depths (PPD) were recorded using a University of North Carolina no. 15 (UNC -15) color-coded periodontal probe at baseline, 120 and 180 days after surgery.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>Changes in dimensions of interdental papilla in mm</measure>
    <time_frame>Baseline to 180 days</time_frame>
    <description>Changes in dimensions of interdental papilla using a periodontal probe.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Assessment of postoperative pain:</measure>
    <time_frame>1 day, 7 &amp; 15 days</time_frame>
    <description>Postoperative pain was assessed by using visual analogue scale (VAS) which was recorded 1 day, 7 &amp; 15 days after surgery. The visual analogue scale (VAS) consists of a line, usually 10 cm long, whose ends are labelled as the extremes ('no pain' and 'severe pain'). The patients were asked to mark on the line which indicated their pain intensity.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Assessment of wound healing:</measure>
    <time_frame>1 day, 7 &amp; 15 days</time_frame>
    <description>Wound healing was recorded using Early wound healing index (EHI).</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">30</enrollment>
  <condition>Periodontitis</condition>
  <arm_group>
    <arm_group_label>Colorado microdissection needle group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>In patients selected for Colorado® needle group incision was given with Colorado® needle tip ( N103 A which is 3 cm length straight, 3/32 in sleeve diameter),</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Cautery group</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Electrosurgery tip was used to give incisions.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>BP Blade group</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>No.15 surgical blade was used to give incisions.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Colorado® microdissection needle</intervention_name>
    <description>The primary feature of the Colorado® microdissection needle is the ultra-sharp tungsten tip that delivers the wave-form from the electrosurgery generator to a very small spot. This allows the use of extremely low wattages, resulting in less tissue necrosis, precision cutting and cautery, and less post-operative pain.</description>
    <arm_group_label>Colorado microdissection needle group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>Cautery tip</intervention_name>
    <description>Studies have shown that, heat generated by electrosurgical devices are influenced by factors like duration of contact between tissue and electrode tip, current intensity, electro section waveform and the electrode tip size. A larger tip causes more tissue damage, increased operating power and more amount of lateral heat production. This led to the development of microdissection needle with fine electrode tip and efficient power usage. The use of microdissection needles does not have any significant difference in wound healing or pain when compared with scalpel.</description>
    <arm_group_label>Cautery group</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>BP blade</intervention_name>
    <description>Studies have shown that, heat generated by electrosurgical devices are influenced by factors like duration of contact between tissue and electrode tip, current intensity, electro section waveform and the electrode tip size. A larger tip causes more tissue damage, increased operating power and more amount of lateral heat production. This led to the development of microdissection needle with fine electrode tip and efficient power usage. The use of microdissection needles does not have any significant difference in wound healing or pain when compared with scalpel.</description>
    <arm_group_label>BP Blade group</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Systemically healthy individuals within the age group of 25-45 years having at least&#xD;
             20 teeth remaining in the mouth of which at least 4 teeth in each quadrant requiring&#xD;
             periodontal surgery, patients with periodontal pockets with ≥5 mm in depth suitable&#xD;
             for modified Widman flap were included in the study.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients who underwent periodontal therapy in the past 6 months, medically compromised&#xD;
             patients, patients with poorly shielded cardiac pacemakers were excluded from the&#xD;
             study.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>25 Years</minimum_age>
    <maximum_age>55 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <location>
    <facility>
      <name>SVS Institute of Dental Sciences, Mahabubnagar</name>
      <address>
        <city>Hyderabad</city>
        <state>Andhra Pradesh</state>
        <zip>509002</zip>
        <country>India</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>India</country>
  </location_countries>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 20, 2016</study_first_submitted>
  <study_first_submitted_qc>December 21, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 28, 2016</study_first_posted>
  <last_update_submitted>December 21, 2016</last_update_submitted>
  <last_update_submitted_qc>December 21, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 28, 2016</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>SVS Institute of Dental Sciences</investigator_affiliation>
    <investigator_full_name>Dr R Viswa Chandra</investigator_full_name>
    <investigator_title>IEC Secretary</investigator_title>
  </responsible_party>
  <keyword>Incisions</keyword>
  <keyword>microdissection needle</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontitis</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
    <ipd_description>Publication data will be shared</ipd_description>
  </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/NCT03003624
org study id: SVSIEC
nct id: NCT03003624
lead sponsor: 
has dmc: Yes
The aim of the present study was to compare the outcomes of incisions made by Colorado®
      microdissection needle, electrosurgery tip and surgical blade during periodontal surgery.
Commercially, many microdissection needle systems are available, such as Stryker Colorado®
      microdissection needle (CMN) (Stryker-Leibinger, Freiburg, Germany) and optimicro™
      microdissection needles. Colorado® microdissection needle (CMN) combine the advantages of
      scalpel and electrosurgery. CMN® was introduced into clinical practice in 1997, with a wide
      array of applications in the field of Ophthalmology, Neurosurgery, and others.

      The primary feature of the Colorado® microdissection needle is the ultra-sharp tungsten tip
      that delivers the wave-form from the electrosurgery generator to a very small spot. This
      allows the use of extremely low wattages, resulting in less tissue necrosis, precision
      cutting and cautery, and less post-operative pain. The instrument tip is a delicately
      machined, insulated tungsten diathermy needle that is compatible with any standard cautery
      hand piece. Tungsten, with its extremely high melting point (>3400°C) provides a heat
      resistant tip that maintains sharpness compared to stainless steel tips that dull rapidly.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Care Provider, Investigator)
measure: Quantity of blood loss in ml
time frame: Immediate postoperative volume
description: Quantity of blood loss by swab weighing method.
measure: PPD in mm
time frame: Baseline to 180 days
description: Probing pocket depths (PPD) were recorded using a University of North Carolina no. 15 (UNC -15) color-coded periodontal probe at baseline, 120 and 180 days after surgery.
measure: Changes in dimensions of interdental papilla in mm
time frame: Baseline to 180 days
description: Changes in dimensions of interdental papilla using a periodontal probe.
measure: Assessment of postoperative pain:
time frame: 1 day, 7 & 15 days
description: Postoperative pain was assessed by using visual analogue scale (VAS) which was recorded 1 day, 7 & 15 days after surgery. The visual analogue scale (VAS) consists of a line, usually 10 cm long, whose ends are labelled as the extremes ('no pain' and 'severe pain'). The patients were asked to mark on the line which indicated their pain intensity.
measure: Assessment of wound healing:
time frame: 1 day, 7 & 15 days
description: Wound healing was recorded using Early wound healing index (EHI).
arm group label: Colorado microdissection needle group
arm group type: Experimental
description: In patients selected for Colorado® needle group incision was given with Colorado® needle tip ( N103 A which is 3 cm length straight, 3/32 in sleeve diameter),
arm group label: Cautery group
arm group type: Experimental
description: Electrosurgery tip was used to give incisions.
arm group label: BP Blade group
arm group type: Active Comparator
description: No.15 surgical blade was used to give incisions.
intervention type: Device
intervention name: Colorado® microdissection needle
description: The primary feature of the Colorado® microdissection needle is the ultra-sharp tungsten tip that delivers the wave-form from the electrosurgery generator to a very small spot. This allows the use of extremely low wattages, resulting in less tissue necrosis, precision cutting and cautery, and less post-operative pain.
arm group label: Colorado microdissection needle group
intervention type: Device
intervention name: Cautery tip
description: Studies have shown that, heat generated by electrosurgical devices are influenced by factors like duration of contact between tissue and electrode tip, current intensity, electro section waveform and the electrode tip size. A larger tip causes more tissue damage, increased operating power and more amount of lateral heat production. This led to the development of microdissection needle with fine electrode tip and efficient power usage. The use of microdissection needles does not have any significant difference in wound healing or pain when compared with scalpel.
arm group label: Cautery group
intervention type: Device
intervention name: BP blade
description: Studies have shown that, heat generated by electrosurgical devices are influenced by factors like duration of contact between tissue and electrode tip, current intensity, electro section waveform and the electrode tip size. A larger tip causes more tissue damage, increased operating power and more amount of lateral heat production. This led to the development of microdissection needle with fine electrode tip and efficient power usage. The use of microdissection needles does not have any significant difference in wound healing or pain when compared with scalpel.
arm group label: BP Blade group
criteria: 
gender: All
minimum age: 25 Years
maximum age: 55 Years
healthy volunteers: Accepts Healthy Volunteers
facility: 
country: India
responsible party type: Principal Investigator
investigator affiliation: SVS Institute of Dental Sciences
investigator full name: Dr R Viswa Chandra
investigator title: IEC Secretary
mesh term: Periodontitis
sharing ipd: No
ipd description: Publication data will be shared