xml: <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/NCT06018584</url>
    </required_header>
    <id_info>
      <org_study_id>2017-07</org_study_id>
      <nct_id>NCT06018584</nct_id>
    </id_info>
    <brief_title>Biostimulation After Tooth Extraction</brief_title>
    <official_title>Effect of Low-Level Laser Therapy in Wound Healing and Post-Operative Pain Management of Primary Molar Teeth Ex-traction: A Randomized Clinical Trial</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Hazal Özer</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Necmettin Erbakan University</source>
    <oversight_info>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
      <is_us_export>No</is_us_export>
    </oversight_info>
    <brief_summary>
      <textblock>
        This study evaluated the effect of low-level laser therapy on postoperative pain and wound&#xD;
        healing in children undergoing primary molar extractions 40children, 6-10 years of age,&#xD;
        systemically healthy, and had atraumatic extraction indications of bilateral primary molar&#xD;
        teeth were included in the study. A randomly selected tooth was extracted under local&#xD;
        anesthesia in the first session. Only the clot formation on the socket was observed and&#xD;
        photographed in the control group. Other group extractions were performed 2weeks later. The&#xD;
        LLLT group was treated with a 980 nm wavelength Doctor Smile Wiser diode laser and&#xD;
        photographed. Non-epithelialized surface measurements were performed with the ImageJ program.&#xD;
        Pain assessment was performed with the Wong-Baker Pain Scale. Statistical analyses were&#xD;
        performed with SPSS software.&#xD;
      </textblock>
    </brief_summary>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">November 1, 2016</start_date>
    <completion_date type="Actual">May 1, 2018</completion_date>
    <primary_completion_date type="Actual">April 1, 2018</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>Sequential Assignment</intervention_model>
      <primary_purpose>Supportive Care</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Wound healing</measure>
      <time_frame>intervention (tooth extraction) day, 3rd day and 7th day</time_frame>
      <description>For the evaluation of soft tissue healing in extraction sockets, intraoral photographs were taken at an angle of 60° to the occlusal surface on the 3rd and 7th days following the extraction session. Non-epithelialized surface measurements were made by two observing physicians using the ImageJ (NIH, Rockville, USA) program.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Pain score</measure>
      <time_frame>intervention day (tooth extraction), 3rd day and 7th day</time_frame>
      <description>Pain assessment in both groups was performed with the Wong-Baker Pain Rating Scale (Wong-Baker FACES Pain Rating Scale PRS). Patients were asked to choose a face or number from the scale, and the selected value was the practitioner dentist on the day of the procedure; other days were recorded by the parent. This scale is graded from 0 to 10. 0 indicates no pain, and 10 marks the most severe pain. It is asked to evaluate the pain according to the facial expression.</description>
    </primary_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Actual">40</enrollment>
    <condition>Dental Caries in Children</condition>
    <condition>Wound Heal</condition>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_type>Sham Comparator</arm_group_type>
      <description>No application was made after the tooth extraction procedure in the control group.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Low- Level Laser Group (Doctor Smile Wiser)</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>In the Laser group, the diode laser device Doctor Smile Wiser (Wiser, Doctor Smile, Milan, Italy) (Figue 1) with a wavelength of 980 nm and a power of 0.5 W was used for LLLT. During the procedure, the patient, physician, and assistant staff wore protective glasses (Wiser, Doctor Smile, Milan, Italy). With 300 mW of energy, a 400 m tip held 1 cm away from the extraction socket was applied to the extraction socket for 60 seconds from three points determined from the vestibule, lingual/palatal, and occlusal surfaces.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Tooth extraction</intervention_name>
      <description>Tooth extractions were performed by a single physician. Topical anesthesia (Xylo-caine, Astra, Södertalje, Switzerland) was applied to the dried mucosa in the area to be lo-calized with the help of an ear stick for 1 minute. Posterior-superior-alveolar nerve block anesthesia and palatal anesthesia were applied for the upper primary molars; Inferi-or-alveolar nerve block anesthesia and lingual anesthesia (Ultracain, Aventis Pharma, Is-tanbul, Turkey) were applied for the lower primary molars. After anesthesia control was achieved, a randomly selected tooth was extracted. Tooth extraction on the other side was performed two weeks later. During the shootings, attention was paid to the traumatic ap-proach. After the control of bleeding was achieved, data were recorded for each group.</description>
      <arm_group_label>Control Group</arm_group_label>
      <arm_group_label>Low- Level Laser Group (Doctor Smile Wiser)</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  indication for tooth extraction in bilateral primary molars&#xD;
  &#xD;
            -  did not have any systemic disease&#xD;
  &#xD;
            -  the use of antibiotics and painkillers was stopped at least 12 hours ago&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  require complicated tooth extractions&#xD;
  &#xD;
            -  systemic disease&#xD;
  &#xD;
            -  the use of antibiotics and painkillers in 12 hours&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>6 Years</minimum_age>
      <maximum_age>10 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 21, 2023</study_first_submitted>
    <study_first_submitted_qc>August 25, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 30, 2023</study_first_posted>
    <last_update_submitted>August 25, 2023</last_update_submitted>
    <last_update_submitted_qc>August 25, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 30, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor-Investigator</responsible_party_type>
      <investigator_affiliation>Necmettin Erbakan University</investigator_affiliation>
      <investigator_full_name>Hazal Özer</investigator_full_name>
      <investigator_title>Assist. Prof.</investigator_title>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Dental Caries</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
      <ipd_description>The IPD can be shared when the paper is published.</ipd_description>
      <ipd_info_type>Study Protocol</ipd_info_type>
      <ipd_info_type>Statistical Analysis Plan (SAP)</ipd_info_type>
      <ipd_info_type>Informed Consent Form (ICF)</ipd_info_type>
      <ipd_info_type>Clinical Study Report (CSR)</ipd_info_type>
      <ipd_time_frame>From 2024 January for five years</ipd_time_frame>
      <ipd_access_criteria>The e-mail requests will be considered.</ipd_access_criteria>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: 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/NCT06018584
  org study id: 2017-07
  nct id: NCT06018584
  lead sponsor: 
  is fda regulated drug: No
  is fda regulated device: No
  is us export: No
  This study evaluated the effect of low-level laser therapy on postoperative pain and wound
        healing in children undergoing primary molar extractions 40children, 6-10 years of age,
        systemically healthy, and had atraumatic extraction indications of bilateral primary molar
        teeth were included in the study. A randomly selected tooth was extracted under local
        anesthesia in the first session. Only the clot formation on the socket was observed and
        photographed in the control group. Other group extractions were performed 2weeks later. The
        LLLT group was treated with a 980 nm wavelength Doctor Smile Wiser diode laser and
        photographed. Non-epithelialized surface measurements were performed with the ImageJ program.
        Pain assessment was performed with the Wong-Baker Pain Scale. Statistical analyses were
        performed with SPSS software.
  allocation: Randomized
  intervention model: Sequential Assignment
  primary purpose: Supportive Care
  masking: None (Open Label)
  measure: Wound healing
  time frame: intervention (tooth extraction) day, 3rd day and 7th day
  description: For the evaluation of soft tissue healing in extraction sockets, intraoral photographs were taken at an angle of 60° to the occlusal surface on the 3rd and 7th days following the extraction session. Non-epithelialized surface measurements were made by two observing physicians using the ImageJ (NIH, Rockville, USA) program.
  measure: Pain score
  time frame: intervention day (tooth extraction), 3rd day and 7th day
  description: Pain assessment in both groups was performed with the Wong-Baker Pain Rating Scale (Wong-Baker FACES Pain Rating Scale PRS). Patients were asked to choose a face or number from the scale, and the selected value was the practitioner dentist on the day of the procedure; other days were recorded by the parent. This scale is graded from 0 to 10. 0 indicates no pain, and 10 marks the most severe pain. It is asked to evaluate the pain according to the facial expression.
  arm group label: Control Group
  arm group type: Sham Comparator
  description: No application was made after the tooth extraction procedure in the control group.
  arm group label: Low- Level Laser Group (Doctor Smile Wiser)
  arm group type: Experimental
  description: In the Laser group, the diode laser device Doctor Smile Wiser (Wiser, Doctor Smile, Milan, Italy) (Figue 1) with a wavelength of 980 nm and a power of 0.5 W was used for LLLT. During the procedure, the patient, physician, and assistant staff wore protective glasses (Wiser, Doctor Smile, Milan, Italy). With 300 mW of energy, a 400 m tip held 1 cm away from the extraction socket was applied to the extraction socket for 60 seconds from three points determined from the vestibule, lingual/palatal, and occlusal surfaces.
  intervention type: Other
  intervention name: Tooth extraction
  description: Tooth extractions were performed by a single physician. Topical anesthesia (Xylo-caine, Astra, Södertalje, Switzerland) was applied to the dried mucosa in the area to be lo-calized with the help of an ear stick for 1 minute. Posterior-superior-alveolar nerve block anesthesia and palatal anesthesia were applied for the upper primary molars; Inferi-or-alveolar nerve block anesthesia and lingual anesthesia (Ultracain, Aventis Pharma, Is-tanbul, Turkey) were applied for the lower primary molars. After anesthesia control was achieved, a randomly selected tooth was extracted. Tooth extraction on the other side was performed two weeks later. During the shootings, attention was paid to the traumatic ap-proach. After the control of bleeding was achieved, data were recorded for each group.
  arm group label: Control Group
  arm group label: Low- Level Laser Group (Doctor Smile Wiser)
  criteria: 
  gender: All
  minimum age: 6 Years
  maximum age: 10 Years
  healthy volunteers: Accepts Healthy Volunteers
  responsible party type: Sponsor-Investigator
  investigator affiliation: Necmettin Erbakan University
  investigator full name: Hazal Özer
  investigator title: Assist. Prof.
  mesh term: Dental Caries
  sharing ipd: Yes
  ipd description: The IPD can be shared when the paper is published.
  ipd info type: Study Protocol
  ipd info type: Statistical Analysis Plan (SAP)
  ipd info type: Informed Consent Form (ICF)
  ipd info type: Clinical Study Report (CSR)
  ipd time frame: From 2024 January for five years
  ipd access criteria: The e-mail requests will be considered.