<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/NCT02995070</url>
  </required_header>
  <id_info>
    <org_study_id>UEPJMF 7</org_study_id>
    <nct_id>NCT02995070</nct_id>
  </id_info>
  <brief_title>Low Intensity Laser Therapy in Connective Tissue Graft for Root Coverage in Smokers</brief_title>
  <official_title>The Influence Low Intensity Laser Therapy (LILT) in Connective Tissue Graft for Root Coverage in Smokers. A Controlled 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 evaluate the influence of therapy with low-intensity laser&#xD;
      technique associated with connective tissue graft for root coverage in smokers and compare&#xD;
      the results with non- smokers&#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 - São José dos Campos, College of&#xD;
      Dentistry.&#xD;
&#xD;
      The selected smokers patients will be randomly allocated by a computer generated list into:&#xD;
&#xD;
      Group CTG (n=15): patients who will receive only the connective tissue graft procedure to&#xD;
      treat gingival recession and a simulation of laser therapy application (SHAM).&#xD;
&#xD;
      Group CTG+ LLLT (n=15): patients who will receive the connective tissue graft procedure to&#xD;
      treat gingival recession plus 8 applications of low-level-laser therapy (LLLT) to treat&#xD;
      gingival recession.&#xD;
&#xD;
      All surgeries will be performed by the same expert periodontist. Before the surgical&#xD;
      procedure, all patients were enlightened about the causes and consequences of gingival&#xD;
      recession and prevention techniques. Factors related to the origin of gingival recession,&#xD;
      such as toothbrush trauma and inflammation caused by biofilm, will be controlled through&#xD;
      instruction on standardized brushing technique to avoid the influence of other hygiene&#xD;
      methods capable of promoting trauma on soft tissues. Standardized dental floss and&#xD;
      toothbrushes were given to patients. The surgical technique adopted in the recession defects&#xD;
      was the trapezoidal-type of coronally advanced flap (CAF) and the connective tissue graft&#xD;
      (CTG) will be removed from palate mucosa . Briefly, a first incision on the palate will be&#xD;
      performed perpendicularly to the long axis of the teeth, 2 to 3 mm apical to the gingival&#xD;
      margin. The mesial-distal length of the incision will be determined by the length of the&#xD;
      graft required to cover the recession. Because the selected recessions were in maxillary&#xD;
      canines and premolars, the lengths of the graft varied minimally (10-12mm). The second&#xD;
      incision will be made parallel to the first one (1-2 mm apically and parallel to the long&#xD;
      axis of the teeth) to separate the subepithelium connective tissue from the epithelial layer.&#xD;
      The incision is carried far enough apically to provide a 7- mm height of connective tissue to&#xD;
      cover the denuded root surface. Afterward, another incision parallel to the long axis of the&#xD;
      teeth starting from the first incision will be performed to separate the subepithelium&#xD;
      connective tissue from the periosteum. Then, the connective tissue graft will be removed from&#xD;
      the palate as atraumatically as possible. Single sutures will be made on the palate (4-0&#xD;
      silk) and the graft will be sutured on the receptor site. The irradiation will be performed&#xD;
      with a Gallium aluminum arsenide laser (GaAlAs) that continuously emitted a wavelength of 660&#xD;
      nm. Thirty milliwatts will be used for 20 seconds and the total applied energy (fluence) will&#xD;
      be 15 Joules per cm2 (3 Joules/ per point and an application time of 4 seconds per point).&#xD;
&#xD;
      Clinical, esthetics, and comfort of patients parameters were assessed at baseline, 3 and 6&#xD;
      months after the procedure.&#xD;
&#xD;
      Quantitative data were recorded as mean ± standard deviation (SD), and normality was tested&#xD;
      using Shapiro-Wilk tests. The probing depth (PD), relative gingival recession (RGR), clinical&#xD;
      attachment level (CAL), keratinized tissue thickness (KTT), keratinized tissue width (KTW),&#xD;
      and dentin hypersensitivity (DH) values were examined by two-way repeated measures ANOVA to&#xD;
      evaluate the differences within and between groups, followed by a Tukey test for multiple&#xD;
      comparisons when the Shapiro-Wilk p value was ≥ 0.05. Those presenting Shapiro-Wilk p values&#xD;
      &lt; 0.05 were analyzed using a Friedman test (for intragroup comparisons) and Mann-Whitney&#xD;
      tests (for intergroup comparisons). Patients' esthetics and discomfort measures using visual&#xD;
      analog scale (VAS) were analyzed by T-tests. The frequency of complete root coverage was&#xD;
      compared using χ2 tests. Intergroup root coverage esthetic score (RES) comparisons were&#xD;
      performed with a T-test. A significance level of 0.05 was adopted.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>September 2016</start_date>
  <completion_date type="Anticipated">July 2017</completion_date>
  <primary_completion_date type="Anticipated">July 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>Double (Participant, Outcomes Assessor)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Percentage of defect coverage</measure>
    <time_frame>6 months</time_frame>
  </primary_outcome>
  <secondary_outcome>
    <measure>Root coverage esthetic score</measure>
    <time_frame>6 months</time_frame>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">30</enrollment>
  <condition>Gingival Recession</condition>
  <arm_group>
    <arm_group_label>CTG + LLLT</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The irradiation will be performed with a GaAlAs diode laser that will continuously emits a wavelength of 660 nm with a power of 30 milliwatts. The patients allocated for the LLLT group will receive the following protocol for laser application: Five (5) points of irradiation will be performed using a total energy density (fluence) of 15 J/cm2 and a time of 20 seconds. 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 seven more applications performed every other day, with a total of 8 laser applications. The power of the equipment will be calibrated prior to each application.</description>
  </arm_group>
  <arm_group>
    <arm_group_label>CTG + 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 will 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 seven more applications performed every other day, with a total of 8 laser applications.</description>
  </arm_group>
  <intervention>
    <intervention_type>Procedure</intervention_type>
    <intervention_name>CTG</intervention_name>
    <description>Periodontal plastic surgery for root coverage by the trapezoidal flap plus connective tissue graft</description>
    <arm_group_label>CTG + LLLT</arm_group_label>
    <arm_group_label>CTG + SHAM</arm_group_label>
    <other_name>Periodontal plastic surgery</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>LLLT</intervention_name>
    <description>Low Level Laser Therapy on the buccal recipient site of connective tissue graft.</description>
    <arm_group_label>CTG + LLLT</arm_group_label>
    <other_name>Low level GaAlAs laser</other_name>
  </intervention>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>SHAM</intervention_name>
    <description>Simulation of GaAlAs laser to irradiation on connective tissue graft recipient site.</description>
    <arm_group_label>CTG + SHAM</arm_group_label>
    <other_name>Low level GaAlAs laser sham</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Patients presenting Miller class I or II gingival recession in the maxillary canines&#xD;
             or premolars&#xD;
&#xD;
          -  Visible cemento-enamel junction (CEJ) with pulp vitality;&#xD;
&#xD;
          -  Patients presenting no signs of active periodontal disease and full-mouth plaque and&#xD;
             bleeding score ≤20%;&#xD;
&#xD;
          -  Patients older than 18 years old; probing depth ˂3 mm in the included teeth;&#xD;
&#xD;
          -  Patients who agreed to participate and signed an informed consent form.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Patients presenting systemic problems that would contraindicate the surgical&#xD;
             procedure;&#xD;
&#xD;
          -  Patients taking medications known to interfere with the wound healing process or that&#xD;
             contraindicate the surgical procedure;&#xD;
&#xD;
          -  Smokers or pregnant women;&#xD;
&#xD;
          -  Patients who underwent periodontal surgery in the area of interest;&#xD;
&#xD;
          -  Patients with orthodontic therapy in progress.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>65 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>
  <overall_contact>
    <last_name>Mauro P Santamaria, PhD</last_name>
    <phone>+55 (16) 981937777</phone>
    <email>mauro.santamaria@ict.unesp.br</email>
  </overall_contact>
  <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>
    <status>Recruiting</status>
    <contact>
      <last_name>Felipe L Neves, Ms</last_name>
      <phone>+ 55 12997993703</phone>
      <email>fe-lucas21@hotmail.com</email>
    </contact>
  </location>
  <location_countries>
    <country>Brazil</country>
  </location_countries>
  <reference>
    <citation>Garcia VG, Macarini VC, de Almeida JM, Bosco AF, Nagata MJ, Okamoto T, Longo M, Theodoro LH. Influence of low-level laser therapy on wound healing in nicotine-treated animals. Lasers Med Sci. 2012 Mar;27(2):437-43. doi: 10.1007/s10103-011-0956-4. Epub 2011 Jul 13.</citation>
    <PMID>21750957</PMID>
  </reference>
  <reference>
    <citation>Ozturan S, Durukan SA, Ozcelik O, Seydaoglu G, Haytac MC. Coronally advanced flap adjunct with low intensity laser therapy: a randomized controlled clinical pilot study. J Clin Periodontol. 2011 Nov;38(11):1055-62. doi: 10.1111/j.1600-051X.2011.01774.x. Epub 2011 Sep 15.</citation>
    <PMID>22092477</PMID>
  </reference>
  <reference>
    <citation>Langer B, Langer L. Subepithelial connective tissue graft technique for root coverage. J Periodontol. 1985 Dec;56(12):715-20. doi: 10.1902/jop.1985.56.12.715.</citation>
    <PMID>3866056</PMID>
  </reference>
  <verification_date>December 2016</verification_date>
  <study_first_submitted>December 13, 2016</study_first_submitted>
  <study_first_submitted_qc>December 13, 2016</study_first_submitted_qc>
  <study_first_posted type="Estimate">December 16, 2016</study_first_posted>
  <last_update_submitted>December 13, 2016</last_update_submitted>
  <last_update_submitted_qc>December 13, 2016</last_update_submitted_qc>
  <last_update_posted type="Estimate">December 16, 2016</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>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Gingival Recession</mesh_term>
  </condition_browse>
  <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/NCT02995070
org study id: UEPJMF 7
nct id: NCT02995070
lead sponsor: 
has dmc: No
The aim of this study is to evaluate the influence of therapy with low-intensity laser
      technique associated with connective tissue graft for root coverage in smokers and compare
      the results with non- smokers
This is a prospective, parallel and controlled clinical trial. The population evaluated in
      the study was selected at Science and Technology Institute - São José dos Campos, College of
      Dentistry.

      The selected smokers patients will be randomly allocated by a computer generated list into:

      Group CTG (n=15): patients who will receive only the connective tissue graft procedure to
      treat gingival recession and a simulation of laser therapy application (SHAM).

      Group CTG+ LLLT (n=15): patients who will receive the connective tissue graft procedure to
      treat gingival recession plus 8 applications of low-level-laser therapy (LLLT) to treat
      gingival recession.

      All surgeries will be performed by the same expert periodontist. Before the surgical
      procedure, all patients were enlightened about the causes and consequences of gingival
      recession and prevention techniques. Factors related to the origin of gingival recession,
      such as toothbrush trauma and inflammation caused by biofilm, will be controlled through
      instruction on standardized brushing technique to avoid the influence of other hygiene
      methods capable of promoting trauma on soft tissues. Standardized dental floss and
      toothbrushes were given to patients. The surgical technique adopted in the recession defects
      was the trapezoidal-type of coronally advanced flap (CAF) and the connective tissue graft
      (CTG) will be removed from palate mucosa . Briefly, a first incision on the palate will be
      performed perpendicularly to the long axis of the teeth, 2 to 3 mm apical to the gingival
      margin. The mesial-distal length of the incision will be determined by the length of the
      graft required to cover the recession. Because the selected recessions were in maxillary
      canines and premolars, the lengths of the graft varied minimally (10-12mm). The second
      incision will be made parallel to the first one (1-2 mm apically and parallel to the long
      axis of the teeth) to separate the subepithelium connective tissue from the epithelial layer.
      The incision is carried far enough apically to provide a 7- mm height of connective tissue to
      cover the denuded root surface. Afterward, another incision parallel to the long axis of the
      teeth starting from the first incision will be performed to separate the subepithelium
      connective tissue from the periosteum. Then, the connective tissue graft will be removed from
      the palate as atraumatically as possible. Single sutures will be made on the palate (4-0
      silk) and the graft will be sutured on the receptor site. The irradiation will be performed
      with a Gallium aluminum arsenide laser (GaAlAs) that continuously emitted a wavelength of 660
      nm. Thirty milliwatts will be used for 20 seconds and the total applied energy (fluence) will
      be 15 Joules per cm2 (3 Joules/ per point and an application time of 4 seconds per point).

      Clinical, esthetics, and comfort of patients parameters were assessed at baseline, 3 and 6
      months after the procedure.

      Quantitative data were recorded as mean ± standard deviation (SD), and normality was tested
      using Shapiro-Wilk tests. The probing depth (PD), relative gingival recession (RGR), clinical
      attachment level (CAL), keratinized tissue thickness (KTT), keratinized tissue width (KTW),
      and dentin hypersensitivity (DH) values were examined by two-way repeated measures ANOVA to
      evaluate the differences within and between groups, followed by a Tukey test for multiple
      comparisons when the Shapiro-Wilk p value was ≥ 0.05. Those presenting Shapiro-Wilk p values
      < 0.05 were analyzed using a Friedman test (for intragroup comparisons) and Mann-Whitney
      tests (for intergroup comparisons). Patients' esthetics and discomfort measures using visual
      analog scale (VAS) were analyzed by T-tests. The frequency of complete root coverage was
      compared using χ2 tests. Intergroup root coverage esthetic score (RES) comparisons were
      performed with a T-test. A significance level of 0.05 was adopted.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Treatment
masking: Double (Participant, Outcomes Assessor)
measure: Percentage of defect coverage
time frame: 6 months
measure: Root coverage esthetic score
time frame: 6 months
arm group label: CTG + LLLT
arm group type: Experimental
description: The irradiation will be performed with a GaAlAs diode laser that will continuously emits a wavelength of 660 nm with a power of 30 milliwatts. The patients allocated for the LLLT group will receive the following protocol for laser application: Five (5) points of irradiation will be performed using a total energy density (fluence) of 15 J/cm2 and a time of 20 seconds. 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 seven more applications performed every other day, with a total of 8 laser applications. The power of the equipment will be calibrated prior to each application.
arm group label: CTG + 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 will 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 seven more applications performed every other day, with a total of 8 laser applications.
intervention type: Procedure
intervention name: CTG
description: Periodontal plastic surgery for root coverage by the trapezoidal flap plus connective tissue graft
arm group label: CTG + LLLT
arm group label: CTG + SHAM
other name: Periodontal plastic surgery
intervention type: Device
intervention name: LLLT
description: Low Level Laser Therapy on the buccal recipient site of connective tissue graft.
arm group label: CTG + LLLT
other name: Low level GaAlAs laser
intervention type: Device
intervention name: SHAM
description: Simulation of GaAlAs laser to irradiation on connective tissue graft recipient site.
arm group label: CTG + SHAM
other name: Low level GaAlAs laser sham
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Mauro P Santamaria, PhD
role: Principal Investigator
affiliation: ICT-UNESP
last name: Mauro P Santamaria, PhD
phone: +55 (16) 981937777
email: mauro.santamaria@ict.unesp.br
facility: 
status: Recruiting
contact: 
country: Brazil
citation: Garcia VG, Macarini VC, de Almeida JM, Bosco AF, Nagata MJ, Okamoto T, Longo M, Theodoro LH. Influence of low-level laser therapy on wound healing in nicotine-treated animals. Lasers Med Sci. 2012 Mar;27(2):437-43. doi: 10.1007/s10103-011-0956-4. Epub 2011 Jul 13.
PMID: 21750957
citation: Ozturan S, Durukan SA, Ozcelik O, Seydaoglu G, Haytac MC. Coronally advanced flap adjunct with low intensity laser therapy: a randomized controlled clinical pilot study. J Clin Periodontol. 2011 Nov;38(11):1055-62. doi: 10.1111/j.1600-051X.2011.01774.x. Epub 2011 Sep 15.
PMID: 22092477
citation: Langer B, Langer L. Subepithelial connective tissue graft technique for root coverage. J Periodontol. 1985 Dec;56(12):715-20. doi: 10.1902/jop.1985.56.12.715.
PMID: 3866056
responsible party type: Principal Investigator
investigator affiliation: Universidade Estadual Paulista Júlio de Mesquita Filho
investigator full name: Mauro Pedrine Santamaria
investigator title: Assistant Professor
mesh term: Gingival Recession
sharing ipd: Undecided