<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/NCT02239042</url>
  </required_header>
  <id_info>
    <org_study_id>132.831</org_study_id>
    <nct_id>NCT02239042</nct_id>
  </id_info>
  <brief_title>Effect of Low-level Laser Therapy on Palatal Wound Healing</brief_title>
  <acronym>LLLT</acronym>
  <official_title>Effect of Gallium-Aluminum-Arsenide Laser - AsGaAl Low-level Laser Therapy on the Healing of Human Palate Mucosa After Connective Tissue Graft Harvesting: Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>UPECLIN HC FM Botucatu Unesp</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>UPECLIN HC FM Botucatu Unesp</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of the present study was to evaluate the influence of LLLT on the recovery of the&#xD;
      palatine donor site wounds after harvest connective tissue graft.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This was a prospective, parallel and controlled clinical trial. The population evaluated in&#xD;
      this study was selected at Science and Technology Institute - ICT - São José dos Campos,&#xD;
      College of Dentistry&#xD;
&#xD;
      The selected patients were randomly allocated (by a computer generated list) into:&#xD;
&#xD;
        -  Group 1 (Test, n=16): Periodontal surgery for root coverage through connective tissue&#xD;
           graft and LLLT on donor site.&#xD;
&#xD;
        -  Group 2 (Control, n=16): Periodontal surgery for root coverage through connective tissue&#xD;
           graft and LLLT SHAM on donor site.&#xD;
&#xD;
      Surgical procedure was performed by one surgeon. The gingival recession defects were treated&#xD;
      by connective tissue graft technique. A connective tissue graft was removed from palate&#xD;
      mucosa following Bruno technique. Briefly, a first incision on the palate was performed&#xD;
      perpendicularly to the long axis of the teeth, 2 to 3 mm apical to the gingival margin. The&#xD;
      mesiodistal length of the incision was determined by the length of the graft required to&#xD;
      cover the recession. Since the selected recessions were in maxillary canines and premolars,&#xD;
      the length of the graft vary minimally (10-12mm). The second incision was made parallel to&#xD;
      the first one, 1-2mm apically, and parallel to the long axis of the teeth in order to&#xD;
      separate the subepithelium connective tissue from the epithelial layer. The incision is&#xD;
      carried far enough apically to provide a 7mm height of connective tissue to cover the denuded&#xD;
      root surface. Afterwards, another incision parallel to the long axis of the teeth, starting&#xD;
      from the first incision was performed to separate the subepithelium connective tissue from&#xD;
      the periosteum. Then, the connective tissue graft was removed from the palate as&#xD;
      atraumatically as possible. Single sutures were made on the palate (4-0 silk) and the graft&#xD;
      was sutured on the receptor site&#xD;
&#xD;
      Clinical parameters were assessed at baseline and 7, 14, 45, 60 and 90 days post-operatively&#xD;
&#xD;
      Statistical Analysis The null hypothesis considered in the study was the absence of&#xD;
      difference in the clinical parameters between the different groups. For data analysis, the&#xD;
      statistical program was used. The demographic and clinical data were compared between the&#xD;
      groups using Student's t-test. The data were first analyzed for homogeneity using the&#xD;
      Shapiro-Wilk test, which indicated non-normal distribution. . Those presenting Shapiro-Wilk p&#xD;
      values &lt; 0.05 were analyzed using a Friedman test (for intragroup comparisons) and&#xD;
      Mann-Whitney tests (for intergroup comparisons). For remaining wound area, tissue&#xD;
      colorimetry, tissue thickness, and post-operative discomfort parameter analysis, Two Way&#xD;
      Repeated Measures ANOVA was performed for intra and intergroup analysis. T-test was used for&#xD;
      intergroup comparison of number of analgesics taken. Presence or absence of scar was measured&#xD;
      by Q-square test. For all tests significance level of 5% was used.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>October 2011</start_date>
  <completion_date type="Actual">June 2013</completion_date>
  <primary_completion_date type="Actual">June 2013</primary_completion_date>
  <phase>Phase 4</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Single Group Assignment</intervention_model>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Change in the Remaining wound area (RWA)</measure>
    <time_frame>7, 14, 45 and 60 post-operative days</time_frame>
    <description>For this, standardized photographs were taken (brightness, distance and angle). A scale was used as a reference to measure this area. Theses photographs were exported to image software (Image J - NIH, Bethesda, USA) and the wound area was measured in square millimeters</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Post-operative discomfort</measure>
    <time_frame>7, 14, 45 and 60 days after surgical procedure</time_frame>
    <description>After air spray application, patients were required to fill a visual analogue scale (VAS), of 100mm, where the scale extremes were &quot;no pain&quot; to &quot;extreme&quot; to report measurement discomfort.</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Tissue thickness</measure>
    <time_frame>Before and 90 days after surgery</time_frame>
    <description>Through four fixed points (5mm and 7mm distant to gingival margin) from the operated region, tissue thickness of palatine masticatory mucosa before the procedure and 3 months after the procedure were assessed. One stent was made to standardize the points to be measured. The stent was positioned and, with a periodontal probe, the points were marked. Then the stent was removed and measures were made. For this, an endodontic spacer with a rubber cursor was put on the marked points for it to reach palatine bone plate. Then the cursor was taken to the tissue, not pressuring it. The distance between the spacer tip to the cursor was measured using a digital caliper</description>
  </other_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Actual">32</enrollment>
  <condition>Palatal Wound</condition>
  <arm_group>
    <arm_group_label>Low-level laser therapy (LLLT) Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>LLLT Sham on the palatal donor site of connective tissue graft</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Low-level laser therapy (LLLT)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>LLLT on the palatal donor site of connective tissue graft</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>LLLT</intervention_name>
    <description>The patients allocated for the test group received the following protocol for laser application: Five (5) points of irradiation were performed. The irradiation was performed with a ASGaAl diode laser that continuously emitted a wavelength of 660 nm. 30 mW was used for 20 seconds, and the total applied energy density (fluence) was 15 J/cm2 (3 J/cm2 per point and an application time of 4 seconds per point). The applications were performed using punctual contact (to reduce reflection) with the tip perpendicular to the gingival tissue. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was followed by seven more applications performed every other day, with a total of 8 laser applications. The power of the equipment was calibrated prior to each application. The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue</description>
    <arm_group_label>Low-level laser therapy (LLLT)</arm_group_label>
    <arm_group_label>Low-level laser therapy (LLLT) Sham</arm_group_label>
    <other_name>Low-level laser therapy (LLLT) after Coronally advanced falp and connective tissue graft technique to treat gingival recessions on the donor site</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients that were 20 to 70 years old, both genders; presenting gingival recession&#xD;
             Class I or II Miller, on vital canines or pre-molars, palatine region (donor site)&#xD;
             with no pathological or morphological alterations; patients who agreed with and signed&#xD;
             the formal consent to participate in the study, after receiving an explanation of&#xD;
             risks and benefits, by an individual who was not a member of the present study&#xD;
             (Resolution no. 196 - October, 1996, and Ethics and Code of Professional Conduct in&#xD;
             Dentistry - CFO 179/93).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients with systemic problems that contraindicated surgical procedure; patients&#xD;
             under medication that would interfere with the wound healing; patients who smoked;&#xD;
             patients who were pregnant or lactating; patients who had had periodontal surgery on&#xD;
             the study area.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>20 Years</minimum_age>
    <maximum_age>70 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Mauro Santamaria, DDS, Ms, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>FOSJC-UNESP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Fosjc-Unesp</name>
      <address>
        <city>São Jose dos Campos/ SP</city>
        <state>Non-US Resident</state>
        <zip>12245-000</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <verification_date>September 2014</verification_date>
  <study_first_submitted>September 2, 2014</study_first_submitted>
  <study_first_submitted_qc>September 10, 2014</study_first_submitted_qc>
  <study_first_posted type="Estimate">September 12, 2014</study_first_posted>
  <last_update_submitted>September 10, 2014</last_update_submitted>
  <last_update_submitted_qc>September 10, 2014</last_update_submitted_qc>
  <last_update_posted type="Estimate">September 12, 2014</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>UPECLIN HC FM Botucatu Unesp</investigator_affiliation>
    <investigator_full_name>Mauro Pedrine Santamaria</investigator_full_name>
    <investigator_title>Researcher - Principal investigator</investigator_title>
  </responsible_party>
  <keyword>Gingival recessions</keyword>
  <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>


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/NCT02239042
org study id: 132.831
nct id: NCT02239042
lead sponsor: 
has dmc: No
The aim of the present study was to evaluate the influence of LLLT on the recovery of the
      palatine donor site wounds after harvest connective tissue graft.
This was a prospective, parallel and controlled clinical trial. The population evaluated in
      this study was selected at Science and Technology Institute - ICT - São José dos Campos,
      College of Dentistry

      The selected patients were randomly allocated (by a computer generated list) into:

        -  Group 1 (Test, n=16): Periodontal surgery for root coverage through connective tissue
           graft and LLLT on donor site.

        -  Group 2 (Control, n=16): Periodontal surgery for root coverage through connective tissue
           graft and LLLT SHAM on donor site.

      Surgical procedure was performed by one surgeon. The gingival recession defects were treated
      by connective tissue graft technique. A connective tissue graft was removed from palate
      mucosa following Bruno technique. Briefly, a first incision on the palate was performed
      perpendicularly to the long axis of the teeth, 2 to 3 mm apical to the gingival margin. The
      mesiodistal length of the incision was determined by the length of the graft required to
      cover the recession. Since the selected recessions were in maxillary canines and premolars,
      the length of the graft vary minimally (10-12mm). The second incision was made parallel to
      the first one, 1-2mm apically, and parallel to the long axis of the teeth in order to
      separate the subepithelium connective tissue from the epithelial layer. The incision is
      carried far enough apically to provide a 7mm height of connective tissue to cover the denuded
      root surface. Afterwards, another incision parallel to the long axis of the teeth, starting
      from the first incision was performed to separate the subepithelium connective tissue from
      the periosteum. Then, the connective tissue graft was removed from the palate as
      atraumatically as possible. Single sutures were made on the palate (4-0 silk) and the graft
      was sutured on the receptor site

      Clinical parameters were assessed at baseline and 7, 14, 45, 60 and 90 days post-operatively

      Statistical Analysis The null hypothesis considered in the study was the absence of
      difference in the clinical parameters between the different groups. For data analysis, the
      statistical program was used. The demographic and clinical data were compared between the
      groups using Student's t-test. The data were first analyzed for homogeneity using the
      Shapiro-Wilk test, which indicated non-normal distribution. . Those presenting Shapiro-Wilk p
      values < 0.05 were analyzed using a Friedman test (for intragroup comparisons) and
      Mann-Whitney tests (for intergroup comparisons). For remaining wound area, tissue
      colorimetry, tissue thickness, and post-operative discomfort parameter analysis, Two Way
      Repeated Measures ANOVA was performed for intra and intergroup analysis. T-test was used for
      intergroup comparison of number of analgesics taken. Presence or absence of scar was measured
      by Q-square test. For all tests significance level of 5% was used.
allocation: Randomized
intervention model: Single Group Assignment
primary purpose: Treatment
masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
measure: Change in the Remaining wound area (RWA)
time frame: 7, 14, 45 and 60 post-operative days
description: For this, standardized photographs were taken (brightness, distance and angle). A scale was used as a reference to measure this area. Theses photographs were exported to image software (Image J - NIH, Bethesda, USA) and the wound area was measured in square millimeters
measure: Post-operative discomfort
time frame: 7, 14, 45 and 60 days after surgical procedure
description: After air spray application, patients were required to fill a visual analogue scale (VAS), of 100mm, where the scale extremes were "no pain" to "extreme" to report measurement discomfort.
measure: Tissue thickness
time frame: Before and 90 days after surgery
description: Through four fixed points (5mm and 7mm distant to gingival margin) from the operated region, tissue thickness of palatine masticatory mucosa before the procedure and 3 months after the procedure were assessed. One stent was made to standardize the points to be measured. The stent was positioned and, with a periodontal probe, the points were marked. Then the stent was removed and measures were made. For this, an endodontic spacer with a rubber cursor was put on the marked points for it to reach palatine bone plate. Then the cursor was taken to the tissue, not pressuring it. The distance between the spacer tip to the cursor was measured using a digital caliper
arm group label: Low-level laser therapy (LLLT) Sham
arm group type: Sham Comparator
description: LLLT Sham on the palatal donor site of connective tissue graft
arm group label: Low-level laser therapy (LLLT)
arm group type: Experimental
description: LLLT on the palatal donor site of connective tissue graft
intervention type: Procedure
intervention name: LLLT
description: The patients allocated for the test group received the following protocol for laser application: Five (5) points of irradiation were performed. The irradiation was performed with a ASGaAl diode laser that continuously emitted a wavelength of 660 nm. 30 mW was used for 20 seconds, and the total applied energy density (fluence) was 15 J/cm2 (3 J/cm2 per point and an application time of 4 seconds per point). The applications were performed using punctual contact (to reduce reflection) with the tip perpendicular to the gingival tissue. Laser therapy was initiated in the immediate postoperative period (just after sutures) and was followed by seven more applications performed every other day, with a total of 8 laser applications. The power of the equipment was calibrated prior to each application. The patients allocated to the control group received sham irradiation. For this, black rubber protection was placed at the tip of the laser device, which did not allow the light to reach the tissue
arm group label: Low-level laser therapy (LLLT)
arm group label: Low-level laser therapy (LLLT) Sham
other name: Low-level laser therapy (LLLT) after Coronally advanced falp and connective tissue graft technique to treat gingival recessions on the donor site
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mauro Santamaria, DDS, Ms, PhD
role: Principal Investigator
affiliation: FOSJC-UNESP
facility: 
country: Brazil
responsible party type: Principal Investigator
investigator affiliation: UPECLIN HC FM Botucatu Unesp
investigator full name: Mauro Pedrine Santamaria
investigator title: Researcher - Principal investigator
mesh term: Wounds and Injuries