<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/NCT03001791</url>
  </required_header>
  <id_info>
    <org_study_id>271-13</org_study_id>
    <nct_id>NCT03001791</nct_id>
  </id_info>
  <brief_title>Comparison of ER:YAG Laser, CO2 Laser and Scalpel Excision of Fibrous Hyperplasia on the Buccal Mucosa</brief_title>
  <official_title>Clinical and Histopathological Comparison of ER:YAG Laser, CO2 Laser and Scalpel Excision of Fibrous Hyperplasia on the Buccal Mucosa</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Bern</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>University of Bern</source>
  <brief_summary>
    <textblock>
      The aim of the RCT is to analyse clinical and histopathological particularities for&#xD;
      excisional biopsies of fibrous hyperplasia in the buccal mucosa performed with Er:YAG laser,&#xD;
      CO2 laser and scalpel. The primary outcome parameter is to evaluate the thermal damage zone&#xD;
      on the excised specimens. Secondary parameters are time of surgery, intraoperative bleeding,&#xD;
      the need for additional electrocoagulation or sutures and patient's postsurgical perception&#xD;
      of pain, other postsurgical effects and use of analgesics.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Completed</overall_status>
  <start_date>July 2013</start_date>
  <completion_date type="Actual">August 10, 2017</completion_date>
  <primary_completion_date type="Actual">July 4, 2017</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 (Participant)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Histopathological thermal damage zone</measure>
    <time_frame>Three months</time_frame>
    <description>Biopsy specimens fixed in a 4% neutral-buffered formalin solution, embedded in paraffin, sectioned in slices of 5 μm, and stained with hematoxylin-eosin.&#xD;
Measurements of the thermal damage zone (in μm) on histopathological specimens by pathologist, blinded to the surgical method used. Measurements of the maximal and the minimal thermal damage zone on a representative section on both lateral edges of the fibrous hyperplasia.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Postoperative Pain</measure>
    <time_frame>Two weeks</time_frame>
    <description>Registration of pain on VAS scale (ranging 0-100) during 14 days. The first VAS value was filled in before surgery, the second value in the evening after surgery and then on each of the following days on a study form handed out to patient.&#xD;
Intake of Analgesic (type, dose) are also filled in by patient on the study form i a specific section.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Number of patients with other postoperative effects</measure>
    <time_frame>Two weeks</time_frame>
    <description>Number of patients with other postoperative events (e.g. swelling, bleeding) on the same study form</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Time of surgery</measure>
    <time_frame>15 minutes</time_frame>
    <description>Registration of time of intervention with a stopwatch. It starts when the laser beam is first applied and ends when the wound paste had been applied.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Bleeding during surgery</measure>
    <time_frame>15 minutes</time_frame>
    <description>Registration of bleeding events (yes/no) and method to stop the bleeding during surgery (electrocautery, sutures)</description>
  </secondary_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">75</enrollment>
  <condition>Fibrous Hyperplasia on Oral Mucosa</condition>
  <arm_group>
    <arm_group_label>Er:YAG laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Excisional biopsy of fibrous hyperplasia with Er:YAG laser (Lite TouchTM, Synergon Dental Lasers, Light instruments Ltd., Yokneam Elite, Israel), λ = 2940nnm. Soft tissue biopsy mode with water cooling, frequency 35 Hz, pulse duration 250-390 µsec, pulse energy of 200 mJ, power 7 Watt . Cylindrical sapphire tip, 400 µm in diameter, without contact to the tissue.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CO2 laser</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Excisional biopsy of fibrous hyperplasia with CO2 laser (Spectra DENTA Surgical Carbon Dioxide Laser, MAX Engineering Ltd., Gyeonggi-Do, Korea), λ = 10'600nnm. cf mode (frequency 140 Hz, pulse duration 400 µsec, pulse energy 33 mJ,a power 4.62 watts). Laser beam with a spot size of 0.2 mm, non-contact mode.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Scalpel</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>Excisional biopsy of fibrous hyperplasia with scalpel (blade 15C). Polyamide sutures (Seralon 5-DS15, Serag Wiessner KG, Naila, Germany).</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Excisional biopsy with Er:YAG laser</intervention_name>
    <description>Excisional biopsy of fibrous hyperplasia in the buccal mucosa in local anesthesia with Er:YAG laser (Lite TouchTM, Synergon Dental Lasers, Light instruments Ltd., Yokneam Elite, Israel), λ = 2940nnm. Soft tissue biopsy mode with water cooling, frequency 35 Hz, pulse duration 250-390 µsec, pulse energy of 200 mJ, power 7 Watt . Cylindrical sapphire tip, 400 µm in diameter, without contact to the tissue.</description>
    <arm_group_label>Er:YAG laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Excisional biopsy with CO2 laser</intervention_name>
    <description>Excisional biopsy of fibrous hyperplasia in the buccal mucosa in local anesthesia with CO2 laser (Spectra DENTA Surgical Carbon Dioxide Laser, MAX Engineering Ltd., Gyeonggi-Do, Korea), λ = 10'600nnm. cf mode (frequency 140 Hz, pulse duration 400 µsec, pulse energy 33 mJ,a power 4.62 watts). Laser beam with a spot size of 0.2 mm, non-contact mode.</description>
    <arm_group_label>CO2 laser</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Excisional biopsy with scalpel</intervention_name>
    <description>Excisional biopsy of fibrous hyperplasia in the buccal mucosa in local anesthesia with scalpel (blade 15C). Polyamide sutures (Seralon 5-DS15, Serag Wiessner KG, Naila, Germany).</description>
    <arm_group_label>Scalpel</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Clinical tentative diagnosis of fibrous hyperplasia in the buccal mucosa&#xD;
&#xD;
          -  Fibrous hyperplasia dimensions 0.5 to 2 cm&#xD;
&#xD;
          -  Patient understands and reads the German language&#xD;
&#xD;
          -  Written informed consent&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Untreated diabetes Typ II&#xD;
&#xD;
          -  Severe infectious disease (HIV, hepatitis)&#xD;
&#xD;
          -  Severe psychiatric disease&#xD;
&#xD;
          -  Immunosuppressive therapy&#xD;
&#xD;
          -  Anticoagulation&#xD;
&#xD;
          -  Pregnancy; a pregnancy test (Clearblue®) is performed in women of childbearing age&#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>
  <overall_official>
    <last_name>Valerie GA Suter, Dr med dent</last_name>
    <role>Principal Investigator</role>
    <affiliation>Department of Oral Surgery and Stomatology, Dental School, University of Bern</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Department of oral Surgery and Stomatology, Dental school, University Bern</name>
      <address>
        <city>Bern</city>
        <zip>3010</zip>
        <country>Switzerland</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Switzerland</country>
  </location_countries>
  <verification_date>November 2017</verification_date>
  <study_first_submitted>November 14, 2016</study_first_submitted>
  <study_first_submitted_qc>December 20, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 23, 2016</study_first_posted>
  <last_update_submitted>November 24, 2017</last_update_submitted>
  <last_update_submitted_qc>November 24, 2017</last_update_submitted_qc>
  <last_update_posted type="Actual">November 27, 2017</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>CO2 laser</keyword>
  <keyword>thermal damage zone</keyword>
  <keyword>Er:YAG laser</keyword>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Hyperplasia</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/NCT03001791
org study id: 271-13
nct id: NCT03001791
lead sponsor: 
The aim of the RCT is to analyse clinical and histopathological particularities for
      excisional biopsies of fibrous hyperplasia in the buccal mucosa performed with Er:YAG laser,
      CO2 laser and scalpel. The primary outcome parameter is to evaluate the thermal damage zone
      on the excised specimens. Secondary parameters are time of surgery, intraoperative bleeding,
      the need for additional electrocoagulation or sutures and patient's postsurgical perception
      of pain, other postsurgical effects and use of analgesics.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Single (Participant)
measure: Histopathological thermal damage zone
time frame: Three months
description: Biopsy specimens fixed in a 4% neutral-buffered formalin solution, embedded in paraffin, sectioned in slices of 5 μm, and stained with hematoxylin-eosin.
Measurements of the thermal damage zone (in μm) on histopathological specimens by pathologist, blinded to the surgical method used. Measurements of the maximal and the minimal thermal damage zone on a representative section on both lateral edges of the fibrous hyperplasia.
measure: Postoperative Pain
time frame: Two weeks
description: Registration of pain on VAS scale (ranging 0-100) during 14 days. The first VAS value was filled in before surgery, the second value in the evening after surgery and then on each of the following days on a study form handed out to patient.
Intake of Analgesic (type, dose) are also filled in by patient on the study form i a specific section.
measure: Number of patients with other postoperative effects
time frame: Two weeks
description: Number of patients with other postoperative events (e.g. swelling, bleeding) on the same study form
measure: Time of surgery
time frame: 15 minutes
description: Registration of time of intervention with a stopwatch. It starts when the laser beam is first applied and ends when the wound paste had been applied.
measure: Bleeding during surgery
time frame: 15 minutes
description: Registration of bleeding events (yes/no) and method to stop the bleeding during surgery (electrocautery, sutures)
arm group label: Er:YAG laser
arm group type: Experimental
description: Excisional biopsy of fibrous hyperplasia with Er:YAG laser (Lite TouchTM, Synergon Dental Lasers, Light instruments Ltd., Yokneam Elite, Israel), λ = 2940nnm. Soft tissue biopsy mode with water cooling, frequency 35 Hz, pulse duration 250-390 µsec, pulse energy of 200 mJ, power 7 Watt . Cylindrical sapphire tip, 400 µm in diameter, without contact to the tissue.
arm group label: CO2 laser
arm group type: Experimental
description: Excisional biopsy of fibrous hyperplasia with CO2 laser (Spectra DENTA Surgical Carbon Dioxide Laser, MAX Engineering Ltd., Gyeonggi-Do, Korea), λ = 10'600nnm. cf mode (frequency 140 Hz, pulse duration 400 µsec, pulse energy 33 mJ,a power 4.62 watts). Laser beam with a spot size of 0.2 mm, non-contact mode.
arm group label: Scalpel
arm group type: Experimental
description: Excisional biopsy of fibrous hyperplasia with scalpel (blade 15C). Polyamide sutures (Seralon 5-DS15, Serag Wiessner KG, Naila, Germany).
intervention type: Procedure
intervention name: Excisional biopsy with Er:YAG laser
description: Excisional biopsy of fibrous hyperplasia in the buccal mucosa in local anesthesia with Er:YAG laser (Lite TouchTM, Synergon Dental Lasers, Light instruments Ltd., Yokneam Elite, Israel), λ = 2940nnm. Soft tissue biopsy mode with water cooling, frequency 35 Hz, pulse duration 250-390 µsec, pulse energy of 200 mJ, power 7 Watt . Cylindrical sapphire tip, 400 µm in diameter, without contact to the tissue.
arm group label: Er:YAG laser
intervention type: Procedure
intervention name: Excisional biopsy with CO2 laser
description: Excisional biopsy of fibrous hyperplasia in the buccal mucosa in local anesthesia with CO2 laser (Spectra DENTA Surgical Carbon Dioxide Laser, MAX Engineering Ltd., Gyeonggi-Do, Korea), λ = 10'600nnm. cf mode (frequency 140 Hz, pulse duration 400 µsec, pulse energy 33 mJ,a power 4.62 watts). Laser beam with a spot size of 0.2 mm, non-contact mode.
arm group label: CO2 laser
intervention type: Procedure
intervention name: Excisional biopsy with scalpel
description: Excisional biopsy of fibrous hyperplasia in the buccal mucosa in local anesthesia with scalpel (blade 15C). Polyamide sutures (Seralon 5-DS15, Serag Wiessner KG, Naila, Germany).
arm group label: Scalpel
criteria: 
gender: All
minimum age: 18 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Valerie GA Suter, Dr med dent
role: Principal Investigator
affiliation: Department of Oral Surgery and Stomatology, Dental School, University of Bern
facility: 
country: Switzerland
responsible party type: Sponsor
mesh term: Hyperplasia