<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/NCT04495335</url>
  </required_header>
  <id_info>
    <org_study_id>2020-04/01</org_study_id>
    <nct_id>NCT04495335</nct_id>
  </id_info>
  <brief_title>Photobiomodulation and Implant Stability</brief_title>
  <acronym>low-laser</acronym>
  <official_title>The Effect of Photobiomodulation Application on Implant Stabilization and Peri-implant Microbiology</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>T.C. Dumlupınar Üniversitesi</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>Gazi University</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>T.C. Dumlupınar Üniversitesi</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Objective: The aim of the present study was to address the following questions: does&#xD;
      photobiomodulation therapy (PBMT) improve implant stability and affect microbiota around&#xD;
      dental implants in the early stage of osseointegration.&#xD;
&#xD;
      Material and Methods: Implants will randomly be divided into two groups and implants will be&#xD;
      placed in the test group treating with Gallium-aluminum-arsenate (GaA1As) diode laser with&#xD;
      photobiomodulation therapy immediately after surgery and for 15 days. In the control group,&#xD;
      implants are not irradiated. The primary stability of the implants will measure by the&#xD;
      Resonance frequency analysis (RFA) after insertion and the secondary stability values will&#xD;
      record at 30th, 60th, and 90th days after surgery as implant stability quotient (ISQ). Plaque&#xD;
      samples will collect for microbiological analyzes at the first 24 hours after implant surgery&#xD;
      and six days after 90 days at six sterile endodontic paper points.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The same surgical procedure will be operated in the test and control groups by the same&#xD;
      surgeon. Full-thickness flaps were raised and dental implant osteotomy preparation will be&#xD;
      completed according to the manufacturers' instructions. Laser treatment will be completed&#xD;
      using Gallium-Aluminum-Arsenide diode laser. The photobiomodulation application will v-be&#xD;
      completed by laser energy immediately and three times a week for just 15 days after surgery.&#xD;
      The control group will consist of laser application without energy delivery to the tissue.&#xD;
      Immediately after implant placement, the third generation stability resonance frequency (RF)&#xD;
      analyzer will be applied for direct measurement of implant stability and the value will be&#xD;
      recorded. The microbiological plaque samples will be collected at specific times, according&#xD;
      to the following schedule; at the first 24-hour and 90 days after implant surgery. All&#xD;
      bacterial DNA specimen will be analyzed with qPCR technique to evaluate Aggregatibacter&#xD;
      actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Prevotella intermedia (Pi) ,&#xD;
      Tannerella forsythia (Tf ) and total amount of bacteria.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date type="Actual">January 1, 2020</start_date>
  <completion_date type="Anticipated">October 30, 2020</completion_date>
  <primary_completion_date type="Anticipated">September 30, 2020</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>
    <intervention_model_description>Implants were randomly divided into two groups and implants placed in the test group were treated with Gallium-aluminum-arsenate (GaA1As) diode laser with photobiomodulation therapy immediately after surgery and for 15 days. In the control group, implants were not irradiated.</intervention_model_description>
    <primary_purpose>Treatment</primary_purpose>
    <masking>Double (Participant, Investigator)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>primary and secondary implant stability</measure>
    <time_frame>The stability was measured at immediately postoperatively.</time_frame>
    <description>Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>primary and secondary implant stability</measure>
    <time_frame>The stability was measured at 30 days postoperatively.</time_frame>
    <description>Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>primary and secondary implant stability</measure>
    <time_frame>The stability was measured at 60 days postoperatively.</time_frame>
    <description>Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded.</description>
  </primary_outcome>
  <primary_outcome>
    <measure>primary and secondary implant stability</measure>
    <time_frame>The stability was measured at 90 days postoperatively.</time_frame>
    <description>Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the number of peri-implant total microorganisms by PCR</measure>
    <time_frame>Microbiological samples will obtained at the first 24-hour after implant surgery</time_frame>
    <description>The sample of the dental implant to be sampled is gently isolated with sterile cotton rolls. Then standardized sterile endodontic paper-points with tip size 40 were inserted into crevice very gently avoiding gingival bleeding. The paper-points were immediately put into sterilized Eppendorf tubes.</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>Evaluation of the number of peri-implant total microorganisms by PCR</measure>
    <time_frame>Microbiological samples will obtained at the 90 days after implant surgery</time_frame>
    <description>The sample of the dental implant to be sampled is gently isolated with sterile cotton rolls. Then standardized sterile endodontic paper-points with tip size 40 were inserted into crevice very gently avoiding gingival bleeding. The paper-points were immediately put into sterilized Eppendorf tubes.</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">90</enrollment>
  <condition>Photobiomodulation Therapy</condition>
  <arm_group>
    <arm_group_label>Test Group (TG)</arm_group_label>
    <arm_group_type>Experimental</arm_group_type>
    <description>The study included test group with Photobiomodulation treatment after dental implant surgery</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control Group (CG)</arm_group_label>
    <arm_group_type>Active Comparator</arm_group_type>
    <description>The control group consisted of laser application without energy delivery to the tissue.</description>
  </arm_group>
  <intervention>
    <intervention_type>Device</intervention_type>
    <intervention_name>photobiomodulation</intervention_name>
    <description>Laser treatment will complete using Gallium-Aluminum-Arsenide (GaA1As) diode laser and application will complete by laser energy immediately and three times a week for just 15 days after surgery.</description>
    <arm_group_label>Control Group (CG)</arm_group_label>
    <arm_group_label>Test Group (TG)</arm_group_label>
    <other_name>low-level laser therapy</other_name>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  at least one tooth loss in left and right posterior sides of upper and lower jaws&#xD;
&#xD;
          -  adequate alveolar bone volume as horizontal and vertical&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  uncontrolled systemic diseases&#xD;
&#xD;
          -  parafunctional (bruxism and/or clenching)&#xD;
&#xD;
          -  smoking habits&#xD;
&#xD;
          -  any allergies or metabolic bone diseases,&#xD;
&#xD;
          -  pregnancy&#xD;
&#xD;
          -  surgical periodontal treatment in 6 months&#xD;
&#xD;
          -  using antibiotics in the last 6 months&#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>Suleyman Bozkaya, DDS PhD</last_name>
    <role>Study Director</role>
    <affiliation>Gazi University Faculty of Dentistry</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Berceste Guler, PhD</last_name>
    <phone>905059359207</phone>
    <email>berceste.guler@ksbu.edu.tr</email>
  </overall_contact>
  <location>
    <facility>
      <name>Kütahya Health Sciences University Faculty of Dentistry</name>
      <address>
        <city>Kütahya</city>
        <zip>43100</zip>
        <country>Turkey</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Berceste Guler, DDs PhD</last_name>
      <phone>905059359207</phone>
      <email>berceste.guler@ksbu.edu.tr</email>
    </contact>
    <investigator>
      <last_name>Ahu Uraz, DDS PhD</last_name>
      <role>Sub-Investigator</role>
    </investigator>
    <investigator>
      <last_name>Suleyman Bozkaya, DDS PhD</last_name>
      <role>Principal Investigator</role>
    </investigator>
  </location>
  <location_countries>
    <country>Turkey</country>
  </location_countries>
  <reference>
    <citation>Lioubavina-Hack N, Lang NP, Karring T. Significance of primary stability for osseointegration of dental implants. Clin Oral Implants Res. 2006 Jun;17(3):244-50. doi: 10.1111/j.1600-0501.2005.01201.x.</citation>
    <PMID>16672018</PMID>
  </reference>
  <reference>
    <citation>Kim YD, Kim SS, Hwang DS, Kim SG, Kwon YH, Shin SH, Kim UK, Kim JR, Chung IK. Effect of low-level laser treatment after installation of dental titanium implant-immunohistochemical study of RANKL, RANK, OPG: an experimental study in rats. Lasers Surg Med. 2007 Jun;39(5):441-50. doi: 10.1002/lsm.20508.</citation>
    <PMID>17523169</PMID>
  </reference>
  <reference>
    <citation>Amid R, Kadkhodazadeh M, Ahsaie MG, Hakakzadeh A. Effect of low level laser therapy on proliferation and differentiation of the cells contributing in bone regeneration. J Lasers Med Sci. 2014 Fall;5(4):163-70.</citation>
    <PMID>25653816</PMID>
  </reference>
  <verification_date>July 2020</verification_date>
  <study_first_submitted>July 26, 2020</study_first_submitted>
  <study_first_submitted_qc>July 29, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 31, 2020</study_first_posted>
  <last_update_submitted>July 29, 2020</last_update_submitted>
  <last_update_submitted_qc>July 29, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">July 31, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>T.C. Dumlupınar Üniversitesi</investigator_affiliation>
    <investigator_full_name>Berceste Guler</investigator_full_name>
    <investigator_title>DDS PhD, Assist Prof</investigator_title>
  </responsible_party>
  <keyword>Low-level laser therapy implants</keyword>
  <patient_data>
    <sharing_ipd>No</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/NCT04495335
org study id: 2020-04/01
nct id: NCT04495335
lead sponsor: 
collaborator: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
Objective: The aim of the present study was to address the following questions: does
      photobiomodulation therapy (PBMT) improve implant stability and affect microbiota around
      dental implants in the early stage of osseointegration.

      Material and Methods: Implants will randomly be divided into two groups and implants will be
      placed in the test group treating with Gallium-aluminum-arsenate (GaA1As) diode laser with
      photobiomodulation therapy immediately after surgery and for 15 days. In the control group,
      implants are not irradiated. The primary stability of the implants will measure by the
      Resonance frequency analysis (RFA) after insertion and the secondary stability values will
      record at 30th, 60th, and 90th days after surgery as implant stability quotient (ISQ). Plaque
      samples will collect for microbiological analyzes at the first 24 hours after implant surgery
      and six days after 90 days at six sterile endodontic paper points.
The same surgical procedure will be operated in the test and control groups by the same
      surgeon. Full-thickness flaps were raised and dental implant osteotomy preparation will be
      completed according to the manufacturers' instructions. Laser treatment will be completed
      using Gallium-Aluminum-Arsenide diode laser. The photobiomodulation application will v-be
      completed by laser energy immediately and three times a week for just 15 days after surgery.
      The control group will consist of laser application without energy delivery to the tissue.
      Immediately after implant placement, the third generation stability resonance frequency (RF)
      analyzer will be applied for direct measurement of implant stability and the value will be
      recorded. The microbiological plaque samples will be collected at specific times, according
      to the following schedule; at the first 24-hour and 90 days after implant surgery. All
      bacterial DNA specimen will be analyzed with qPCR technique to evaluate Aggregatibacter
      actinomycetemcomitans (Aa), Porphyromonas gingivalis (Pg), Prevotella intermedia (Pi) ,
      Tannerella forsythia (Tf ) and total amount of bacteria.
allocation: Randomized
intervention model: Parallel Assignment
intervention model description: Implants were randomly divided into two groups and implants placed in the test group were treated with Gallium-aluminum-arsenate (GaA1As) diode laser with photobiomodulation therapy immediately after surgery and for 15 days. In the control group, implants were not irradiated.
primary purpose: Treatment
masking: Double (Participant, Investigator)
measure: primary and secondary implant stability
time frame: The stability was measured at immediately postoperatively.
description: Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded.
measure: primary and secondary implant stability
time frame: The stability was measured at 30 days postoperatively.
description: Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded.
measure: primary and secondary implant stability
time frame: The stability was measured at 60 days postoperatively.
description: Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded.
measure: primary and secondary implant stability
time frame: The stability was measured at 90 days postoperatively.
description: Immediately after implant placement, the third generation stability resonance frequency (RF) analyzer (Osstell ISQ, Integration Diagnostics AB, Gamlestadsvägen, Goteborg, Sweden) was applied for direct measurement of implant stability and the value was recorded.
measure: Evaluation of the number of peri-implant total microorganisms by PCR
time frame: Microbiological samples will obtained at the first 24-hour after implant surgery
description: The sample of the dental implant to be sampled is gently isolated with sterile cotton rolls. Then standardized sterile endodontic paper-points with tip size 40 were inserted into crevice very gently avoiding gingival bleeding. The paper-points were immediately put into sterilized Eppendorf tubes.
measure: Evaluation of the number of peri-implant total microorganisms by PCR
time frame: Microbiological samples will obtained at the 90 days after implant surgery
description: The sample of the dental implant to be sampled is gently isolated with sterile cotton rolls. Then standardized sterile endodontic paper-points with tip size 40 were inserted into crevice very gently avoiding gingival bleeding. The paper-points were immediately put into sterilized Eppendorf tubes.
arm group label: Test Group (TG)
arm group type: Experimental
description: The study included test group with Photobiomodulation treatment after dental implant surgery
arm group label: Control Group (CG)
arm group type: Active Comparator
description: The control group consisted of laser application without energy delivery to the tissue.
intervention type: Device
intervention name: photobiomodulation
description: Laser treatment will complete using Gallium-Aluminum-Arsenide (GaA1As) diode laser and application will complete by laser energy immediately and three times a week for just 15 days after surgery.
arm group label: Control Group (CG)
arm group label: Test Group (TG)
other name: low-level laser therapy
criteria: 
gender: All
minimum age: 18 Years
maximum age: 65 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Suleyman Bozkaya, DDS PhD
role: Study Director
affiliation: Gazi University Faculty of Dentistry
last name: Berceste Guler, PhD
phone: 905059359207
email: berceste.guler@ksbu.edu.tr
facility: 
status: Recruiting
contact: 
investigator: 
investigator: 
country: Turkey
citation: Lioubavina-Hack N, Lang NP, Karring T. Significance of primary stability for osseointegration of dental implants. Clin Oral Implants Res. 2006 Jun;17(3):244-50. doi: 10.1111/j.1600-0501.2005.01201.x.
PMID: 16672018
citation: Kim YD, Kim SS, Hwang DS, Kim SG, Kwon YH, Shin SH, Kim UK, Kim JR, Chung IK. Effect of low-level laser treatment after installation of dental titanium implant-immunohistochemical study of RANKL, RANK, OPG: an experimental study in rats. Lasers Surg Med. 2007 Jun;39(5):441-50. doi: 10.1002/lsm.20508.
PMID: 17523169
citation: Amid R, Kadkhodazadeh M, Ahsaie MG, Hakakzadeh A. Effect of low level laser therapy on proliferation and differentiation of the cells contributing in bone regeneration. J Lasers Med Sci. 2014 Fall;5(4):163-70.
PMID: 25653816
responsible party type: Principal Investigator
investigator affiliation: T.C. Dumlupınar Üniversitesi
investigator full name: Berceste Guler
investigator title: DDS PhD, Assist Prof
sharing ipd: No