<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/NCT03000426</url>
  </required_header>
  <id_info>
    <org_study_id>UEPJMF 6</org_study_id>
    <nct_id>NCT03000426</nct_id>
  </id_info>
  <brief_title>Photobiomodulation of Palatal Donor Site After Free Gingival Graft Removal</brief_title>
  <official_title>Comparison of Two Energy Densities for Photobiomodulation of Palatal Donor Site After Free Gingival Graft Removal. Randomized Clinical Trial</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Universidade Estadual Paulista Júlio de Mesquita Filho</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Universidade Estadual Paulista Júlio de Mesquita Filho</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      The aim of this study is to compare the influence of two different energy densities for&#xD;
      photobiomodulation on recovery of palatal donor area after free gingival graft technique.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      This is a prospective, parallel and controlled clinical trial. The population evaluated in&#xD;
      the study was selected at Science and Technology Institute (STI) -São José dos Campos,&#xD;
      College of Dentistry.&#xD;
&#xD;
      Patients were assigned to one of the three treatment groups:&#xD;
&#xD;
        -  Group 1: ridge preservation surgery through free gingival graft and photobiomodulation&#xD;
           (PBM) application through a gallium aluminum arsenide laser (GaAlAs) in the donor area&#xD;
           using a 60 Joule/cm² dose&#xD;
&#xD;
        -  Group 2: ridge of preservation surgery through free gingival graft and PBM through a&#xD;
           gallium aluminum arsenide laser (GaAlAs) in the donor area using a 15 Joule/cm² dose&#xD;
&#xD;
        -  Group 3: ridge preservation surgery through free gingival graft and PBM Sham.&#xD;
&#xD;
      All surgeries were performed by the same expert periodontist (MPS). A blade 15c&#xD;
      (Swann-Morton® - Sheffield, England) mounted on No. 3 scalpel handle will make an&#xD;
      intrasulcular incision around the tooth indicated for exodontia. Then, the tooth will be&#xD;
      extracted through the use of appropriate instruments in order to obtain a minimally traumatic&#xD;
      exodontia.&#xD;
&#xD;
      After the exodontia, curettage and irrigation of the dental socket will be performed. After&#xD;
      that, the socket will be filled with xenogenous bone graft (GenOx Inorg; Campinas, SP), and&#xD;
      sealed with a free gingival graft removed from the palate. For the free gingival graft&#xD;
      removal, a circular template of 5 millimeters in diameter will be used. This mold has the&#xD;
      objective of standardizing the palatal graft removal ensuring the wounds will have always the&#xD;
      same size. After the circular incision, the graft will be removed with a thickness of 2&#xD;
      millimeters. After free gingival graft removal from palate, it will be adjusted to the&#xD;
      entrance of the socket and sutured with Vicryl® 5.0 reabsorbable (Ethicon Johnsons do Brasil,&#xD;
      São José dos Campos - SP).&#xD;
&#xD;
      The evaluated parameters were wound remaining area (WRA), scar and tissue colorimetry (TC),&#xD;
      tissue thickness (TT) and postoperative discomfort (D), evaluated at baseline and 7, 14, 45,&#xD;
      60, and 90 days after surgery.&#xD;
&#xD;
      Statistical Analysis: All data were expressed as mean ± standard deviation or expressed in&#xD;
      percentages during the descriptive phase. Data were analyzed according to distribution by the&#xD;
      Shapiro-Wilk test. For the remaining wound area, tissue colorimetry, tissue thickness, and&#xD;
      postoperative discomfort parameter analysis, two way repeated measures ANOVA was performed&#xD;
      for intra- and intergroup analysis. T test was used for intergroup comparison of the number&#xD;
      of analgesics taken. The presence or absence of scars was measured by Q-square test.&#xD;
      Statistical analysis was performed using Sigma Plot 12.0. In all tests a significance level&#xD;
      of 0.05 was chosen.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date>November 2016</start_date>
  <completion_date type="Actual">February 2018</completion_date>
  <primary_completion_date type="Actual">October 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>Triple (Participant, Investigator, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Remaining wound area analyzed through photographs</measure>
    <time_frame>3 months</time_frame>
    <description>The defect area was measured after 90 post-operative days. For this, standardized photographs were taken (in terms of brightness, distance, and angle). A scale was used as a reference to measure the area. These photographs were exported to image software (Image J-NIH, Bethesda, USA), and the wound area was measured in square millimeters (mm²)</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Tissue colorimetric evaluation analyzed through photographs</measure>
    <time_frame>3 months</time_frame>
    <description>Tissue color similarity between the region adjacent to the operated area and the post-operative image were analyzed through photographs. The photographs were exported to image software (Adobe Photoshop 3, München, Germany), and two areas were used: one from the wound and another adjacent area. The areas were measured through the Adobe Photoshop red-green chroma scale and the yellow-blue chroma scale and the results were presented in Bit/Pixels for both scales.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Presence or absence of scars or keloids</measure>
    <time_frame>3 months</time_frame>
    <description>The scar area was measured after 90 post-operative days. For this, standardized photographs were taken (in terms of brightness, distance, and angle). A scale was used as a reference to measure the keloid area. These photographs were exported to image software (Image J-NIH, Bethesda, USA), and the scar extension was measured in square millimeters (mm²)</description>
  </secondary_outcome>
  <other_outcome>
    <measure>Tissue brightness evaluation</measure>
    <time_frame>3 months</time_frame>
    <description>The areas were compared using brightness parameters. The photographs were exported to image software (Adobe Photoshop 3, München, Germany), and two areas were used: one from the wound and another adjacent area. The areas were measured through the Adobe Photoshop, and the results were expressed in a scale from 0 (black) to 255 (white) units of brightness.</description>
  </other_outcome>
  <number_of_arms>3</number_of_arms>
  <enrollment type="Actual">45</enrollment>
  <condition>Palatal Wound</condition>
  <arm_group>
    <arm_group_label>Free gingival graft + PBM Sham</arm_group_label>
    <arm_group_type>Sham Comparator</arm_group_type>
    <description>The patients allocated to the control group will receive sham irradiation. For this, black rubber protection will be placed at the tip of the laser device, which do not allow the light to reach the tissue. The applications will be performed by a different operator from the one who will measure the study parameters. During irradiation, the tip of the laser probe will be placed perpendicularly with slight contact on the area. Laser therapy will be initiated in the immediate postoperative period (just after sutures) and will be repeated by four more applications performed every other day, with a total of 5 laser applications.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Free gingival graft + GaAlAs Laser 60</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The irradiation will be performed with a GaAlAs diode laser that continuously emits a wavelength of 660 nm with a power of 30 milliwatts (mW). The patients allocated for the group 60 will receive the following protocol for laser application: Five (5) points of irradiation will be performed using a total energy density (fluence) of 60 Joules/cm2 and a time of 56 seconds per point (1,68 Joules/cm2 per point). During irradiation, the tip of the laser probe will be placed perpendicularly with slight contact on the area. Laser therapy will be initiated in the immediate postoperative period (just after sutures) and will repeated by four more applications performed every other day, with a total of 5 laser applications. The power of the equipment will be calibrated prior to each application.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Free gingival graft + GaAlAs Laser 15</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The irradiation will be performed with a GaAlAs diode laser that continuously emits a wavelength of 660 nm with a power of 30 milliwatts (mW). The patients allocated for the group 15 will receive the following protocol for laser application: Five (5) points of irradiation will be performed using a total energy density (fluence) of 15 Joules/cm2 and a time of 14 seconds per point (0,42 Joules/cm2 per point). During irradiation, the tip of the laser probe will be placed perpendicularly with slight contact on the area. Laser therapy will be initiated in the immediate postoperative period (just after sutures) and will be repeated by four more applications performed every other day, with a total of 5 laser applications. The power of the equipment will be calibrated prior to each application.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>Free gingival graft</intervention_name>
    <description>Free gingival graft removal from palate for socket preservation</description>
    <arm_group_label>Free gingival graft + GaAlAs Laser 15</arm_group_label>
    <arm_group_label>Free gingival graft + GaAlAs Laser 60</arm_group_label>
    <arm_group_label>Free gingival graft + PBM Sham</arm_group_label>
    <other_name>Socket preservation</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>GaAlAs laser</intervention_name>
    <description>Utilization of GaAlAs laser to irradiation on the palatal donor site for photobiomodulation</description>
    <arm_group_label>Free gingival graft + GaAlAs Laser 15</arm_group_label>
    <arm_group_label>Free gingival graft + GaAlAs Laser 60</arm_group_label>
    <arm_group_label>Free gingival graft + PBM Sham</arm_group_label>
    <other_name>Low level GaAlAs laser</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presenting indication of anterior maxillary exodontia (15 to 25), with normal&#xD;
             gingival contour in the teeth indicated for exodontia; The tooth included in the&#xD;
             study, as well as the adjacent teeth do not present a loss of periodontal insertion.&#xD;
&#xD;
          -  Patients agreed to and signed the formal consent to participate in the study after&#xD;
             receiving an explanation of risks and benefits from an individual who was not a member&#xD;
             of the present study (Resolution no. 196 - October, 1996, and Ethics and Code of&#xD;
             Professional Conduct in Dentistry - 179/93).&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Were excluded patients with systemic problems that contraindicated surgical procedure&#xD;
&#xD;
          -  Those under medication that could interfere with the wound healing&#xD;
&#xD;
          -  Those who smoked&#xD;
&#xD;
          -  Those who were pregnant or lactating, and&#xD;
&#xD;
          -  Those who had had periodontal surgery on 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 P Santamaria, PhD</last_name>
    <role>Principal Investigator</role>
    <affiliation>ICT-UNESP</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Felipe Lucas da Silva Neves</name>
      <address>
        <city>Sao Jose dos Campos</city>
        <state>São Paulo</state>
        <zip>12243-700</zip>
        <country>Brazil</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>da Silva Neves FL, Silveira CA, Dias SB, Santamaria Junior M, de Marco AC, Kerbauy WD, de Melo Filho AB, Jardini MA, Santamaria MP. Comparison of two power densities on the healing of palatal wounds after connective tissue graft removal: randomized clinical trial. Lasers Med Sci. 2016 Sep;31(7):1371-8. doi: 10.1007/s10103-016-1988-6. Epub 2016 Jun 25.</citation>
    <PMID>27344670</PMID>
  </reference>
  <reference>
    <citation>Wagner VP, Meurer L, Martins MA, Danilevicz CK, Magnusson AS, Marques MM, Filho MS, Squarize CH, Martins MD. Influence of different energy densities of laser phototherapy on oral wound healing. J Biomed Opt. 2013 Dec;18(12):128002. doi: 10.1117/1.JBO.18.12.128002.</citation>
    <PMID>24337496</PMID>
  </reference>
  <reference>
    <citation>Ozcelik O, Seydaoglu G, Haytac CM. Diode laser for harvesting de-epithelialized palatal graft in the treatment of gingival recession defects: a randomized clinical trial. J Clin Periodontol. 2016 Jan;43(1):63-71. doi: 10.1111/jcpe.12487. Epub 2016 Jan 21.</citation>
    <PMID>26660000</PMID>
  </reference>
  <verification_date>December 2021</verification_date>
  <study_first_submitted>December 6, 2016</study_first_submitted>
  <study_first_submitted_qc>December 17, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 22, 2016</study_first_posted>
  <last_update_submitted>December 23, 2021</last_update_submitted>
  <last_update_submitted_qc>December 23, 2021</last_update_submitted_qc>
  <last_update_posted type="Actual">December 27, 2021</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Universidade Estadual Paulista Júlio de Mesquita Filho</investigator_affiliation>
    <investigator_full_name>Mauro Pedrine Santamaria</investigator_full_name>
    <investigator_title>Assistant Professor</investigator_title>
  </responsible_party>
  <keyword>Low level laser therapy</keyword>
  <patient_data>
    <sharing_ipd>Undecided</sharing_ipd>
  </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/NCT03000426
org study id: UEPJMF 6
nct id: NCT03000426
lead sponsor: 
has dmc: No
The aim of this study is to compare the influence of two different energy densities for
      photobiomodulation on recovery of palatal donor area after free gingival graft technique.
This is a prospective, parallel and controlled clinical trial. The population evaluated in
      the study was selected at Science and Technology Institute (STI) -São José dos Campos,
      College of Dentistry.

      Patients were assigned to one of the three treatment groups:

        -  Group 1: ridge preservation surgery through free gingival graft and photobiomodulation
           (PBM) application through a gallium aluminum arsenide laser (GaAlAs) in the donor area
           using a 60 Joule/cm² dose

        -  Group 2: ridge of preservation surgery through free gingival graft and PBM through a
           gallium aluminum arsenide laser (GaAlAs) in the donor area using a 15 Joule/cm² dose

        -  Group 3: ridge preservation surgery through free gingival graft and PBM Sham.

      All surgeries were performed by the same expert periodontist (MPS). A blade 15c
      (Swann-Morton® - Sheffield, England) mounted on No. 3 scalpel handle will make an
      intrasulcular incision around the tooth indicated for exodontia. Then, the tooth will be
      extracted through the use of appropriate instruments in order to obtain a minimally traumatic
      exodontia.

      After the exodontia, curettage and irrigation of the dental socket will be performed. After
      that, the socket will be filled with xenogenous bone graft (GenOx Inorg; Campinas, SP), and
      sealed with a free gingival graft removed from the palate. For the free gingival graft
      removal, a circular template of 5 millimeters in diameter will be used. This mold has the
      objective of standardizing the palatal graft removal ensuring the wounds will have always the
      same size. After the circular incision, the graft will be removed with a thickness of 2
      millimeters. After free gingival graft removal from palate, it will be adjusted to the
      entrance of the socket and sutured with Vicryl® 5.0 reabsorbable (Ethicon Johnsons do Brasil,
      São José dos Campos - SP).

      The evaluated parameters were wound remaining area (WRA), scar and tissue colorimetry (TC),
      tissue thickness (TT) and postoperative discomfort (D), evaluated at baseline and 7, 14, 45,
      60, and 90 days after surgery.

      Statistical Analysis: All data were expressed as mean ± standard deviation or expressed in
      percentages during the descriptive phase. Data were analyzed according to distribution by the
      Shapiro-Wilk test. For the remaining wound area, tissue colorimetry, tissue thickness, and
      postoperative discomfort parameter analysis, two way repeated measures ANOVA was performed
      for intra- and intergroup analysis. T test was used for intergroup comparison of the number
      of analgesics taken. The presence or absence of scars was measured by Q-square test.
      Statistical analysis was performed using Sigma Plot 12.0. In all tests a significance level
      of 0.05 was chosen.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Triple (Participant, Investigator, Outcomes Assessor)
measure: Remaining wound area analyzed through photographs
time frame: 3 months
description: The defect area was measured after 90 post-operative days. For this, standardized photographs were taken (in terms of brightness, distance, and angle). A scale was used as a reference to measure the area. These photographs were exported to image software (Image J-NIH, Bethesda, USA), and the wound area was measured in square millimeters (mm²)
measure: Tissue colorimetric evaluation analyzed through photographs
time frame: 3 months
description: Tissue color similarity between the region adjacent to the operated area and the post-operative image were analyzed through photographs. The photographs were exported to image software (Adobe Photoshop 3, München, Germany), and two areas were used: one from the wound and another adjacent area. The areas were measured through the Adobe Photoshop red-green chroma scale and the yellow-blue chroma scale and the results were presented in Bit/Pixels for both scales.
measure: Presence or absence of scars or keloids
time frame: 3 months
description: The scar area was measured after 90 post-operative days. For this, standardized photographs were taken (in terms of brightness, distance, and angle). A scale was used as a reference to measure the keloid area. These photographs were exported to image software (Image J-NIH, Bethesda, USA), and the scar extension was measured in square millimeters (mm²)
measure: Tissue brightness evaluation
time frame: 3 months
description: The areas were compared using brightness parameters. The photographs were exported to image software (Adobe Photoshop 3, München, Germany), and two areas were used: one from the wound and another adjacent area. The areas were measured through the Adobe Photoshop, and the results were expressed in a scale from 0 (black) to 255 (white) units of brightness.
arm group label: Free gingival graft + PBM Sham
arm group type: Sham Comparator
description: The patients allocated to the control group will receive sham irradiation. For this, black rubber protection will be placed at the tip of the laser device, which do not allow the light to reach the tissue. The applications will be performed by a different operator from the one who will measure the study parameters. During irradiation, the tip of the laser probe will be placed perpendicularly with slight contact on the area. Laser therapy will be initiated in the immediate postoperative period (just after sutures) and will be repeated by four more applications performed every other day, with a total of 5 laser applications.
arm group label: Free gingival graft + GaAlAs Laser 60
arm group type: Experimental
description: The irradiation will be performed with a GaAlAs diode laser that continuously emits a wavelength of 660 nm with a power of 30 milliwatts (mW). The patients allocated for the group 60 will receive the following protocol for laser application: Five (5) points of irradiation will be performed using a total energy density (fluence) of 60 Joules/cm2 and a time of 56 seconds per point (1,68 Joules/cm2 per point). During irradiation, the tip of the laser probe will be placed perpendicularly with slight contact on the area. Laser therapy will be initiated in the immediate postoperative period (just after sutures) and will repeated by four more applications performed every other day, with a total of 5 laser applications. The power of the equipment will be calibrated prior to each application.
arm group label: Free gingival graft + GaAlAs Laser 15
arm group type: Experimental
description: The irradiation will be performed with a GaAlAs diode laser that continuously emits a wavelength of 660 nm with a power of 30 milliwatts (mW). The patients allocated for the group 15 will receive the following protocol for laser application: Five (5) points of irradiation will be performed using a total energy density (fluence) of 15 Joules/cm2 and a time of 14 seconds per point (0,42 Joules/cm2 per point). During irradiation, the tip of the laser probe will be placed perpendicularly with slight contact on the area. Laser therapy will be initiated in the immediate postoperative period (just after sutures) and will be repeated by four more applications performed every other day, with a total of 5 laser applications. The power of the equipment will be calibrated prior to each application.
intervention type: Procedure
intervention name: Free gingival graft
description: Free gingival graft removal from palate for socket preservation
arm group label: Free gingival graft + GaAlAs Laser 15
arm group label: Free gingival graft + GaAlAs Laser 60
arm group label: Free gingival graft + PBM Sham
other name: Socket preservation
intervention type: Device
intervention name: GaAlAs laser
description: Utilization of GaAlAs laser to irradiation on the palatal donor site for photobiomodulation
arm group label: Free gingival graft + GaAlAs Laser 15
arm group label: Free gingival graft + GaAlAs Laser 60
arm group label: Free gingival graft + PBM Sham
other name: Low level GaAlAs laser
criteria: 
gender: All
minimum age: 20 Years
maximum age: 70 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mauro P Santamaria, PhD
role: Principal Investigator
affiliation: ICT-UNESP
facility: 
country: Brazil
citation: da Silva Neves FL, Silveira CA, Dias SB, Santamaria Junior M, de Marco AC, Kerbauy WD, de Melo Filho AB, Jardini MA, Santamaria MP. Comparison of two power densities on the healing of palatal wounds after connective tissue graft removal: randomized clinical trial. Lasers Med Sci. 2016 Sep;31(7):1371-8. doi: 10.1007/s10103-016-1988-6. Epub 2016 Jun 25.
PMID: 27344670
citation: Wagner VP, Meurer L, Martins MA, Danilevicz CK, Magnusson AS, Marques MM, Filho MS, Squarize CH, Martins MD. Influence of different energy densities of laser phototherapy on oral wound healing. J Biomed Opt. 2013 Dec;18(12):128002. doi: 10.1117/1.JBO.18.12.128002.
PMID: 24337496
citation: Ozcelik O, Seydaoglu G, Haytac CM. Diode laser for harvesting de-epithelialized palatal graft in the treatment of gingival recession defects: a randomized clinical trial. J Clin Periodontol. 2016 Jan;43(1):63-71. doi: 10.1111/jcpe.12487. Epub 2016 Jan 21.
PMID: 26660000
responsible party type: Principal Investigator
investigator affiliation: Universidade Estadual Paulista Júlio de Mesquita Filho
investigator full name: Mauro Pedrine Santamaria
investigator title: Assistant Professor
sharing ipd: Undecided