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/NCT06026930</url>
    </required_header>
    <id_info>
      <org_study_id>926/91</org_study_id>
      <nct_id>NCT06026930</nct_id>
    </id_info>
    <brief_title>Influence of Low-level Laser Therapy Versus Low-intensity Pulsed Ultrasound on Different Orthodontic Tooth Movements</brief_title>
    <official_title>Influence of Low-level Laser Therapy Versus Low-intensity Pulsed Ultrasound on Different Orthodontic Tooth Movements: A Comparative Clinical Investigation</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Al-Azhar University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Al-Azhar University</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>
        The aim of this prospective clinical project will be to compare the effect of low-level laser&#xD;
        therapy versus low intensity pulsed ultrasound on the rate of different orthodontic tooth&#xD;
        movements&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The aim of this prospective clinical project will be to compare the effect of low-level laser&#xD;
        therapy versus low intensity pulsed ultrasound on the rate of different orthodontic tooth&#xD;
        movements, specifically; canine retraction, incisors' leveling and alignment, maxillary molar&#xD;
        distalization, and incisors' intrusion&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">September 2023</start_date>
    <completion_date type="Anticipated">April 2024</completion_date>
    <primary_completion_date type="Anticipated">March 2024</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>Factorial Assignment</intervention_model>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>Influence of low-level laser therapy versus low-intensity pulsed ultrasound on rate of different orthodontic tooth movements by millimeter</measure>
      <time_frame>post interventionalal at 6months</time_frame>
      <description>rate of orthodontic tooth movement by millimeter</description>
    </primary_outcome>
    <number_of_arms>14</number_of_arms>
    <enrollment type="Anticipated">82</enrollment>
    <condition>Effect of Low Level Laser Versus Low Intensity Pulsed Ultra Sound on Rate of Different Orthodontic Tooth Movement by Millimeter</condition>
    <arm_group>
      <arm_group_label>Lipus side: canine retraction</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>application of LIPUS with translation of maxillary canine that will be performed on intervention sides according to a standardized protocol</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LIPUS side control side</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>LIPUS side:canine retraction control side</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LLLT side canine retraction</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>translation of maxillary canine that will be performed with LLLT application according to a standardized protocol</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LLLT side canine retraction control side</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>LLLT side canine retraction control side wihout intervention</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LIPUS groupMolar distalization group inrervention side</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>distalization assisted with LIPUS according to a standardized protocol</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LIPUS groupMolar distalization group control side</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>distalization without LIPUS intervention</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LLLT group: distalization intervntion side</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>distalization will be commenced with application of LLLT according to a standardized protocol</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LLLT group: distalization control side</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>distalization will be commenced without application of LLLT according to a standardized protocol</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LIPUS group: leveling and alignment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>leveling and alignment assisted with LIPUS according to a standardized protocol</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LLLT group: leveling and alignment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>leveling and alignment be commenced with application of LLLT according to a standardized protocol</description>
    </arm_group>
    <arm_group>
      <arm_group_label>leveling and alignment without intervention</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>leveling and alignment without intervention</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LIPUS group: Intrusion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>intrusion assisted with LIPUS according to a standardized protocol</description>
    </arm_group>
    <arm_group>
      <arm_group_label>LLLT group: Intrusion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>intrusion assisted with application of LLLT according to a standardized protocol</description>
    </arm_group>
    <arm_group>
      <arm_group_label>intrusion control group</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>intrusion without intervention</description>
    </arm_group>
    <intervention>
      <intervention_type>Device</intervention_type>
      <intervention_name>low-level laser therapy</intervention_name>
      <description>LLLT and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.</description>
      <arm_group_label>LIPUS group: Intrusion</arm_group_label>
      <arm_group_label>LIPUS group: leveling and alignment</arm_group_label>
      <arm_group_label>LIPUS groupMolar distalization group inrervention side</arm_group_label>
      <arm_group_label>LLLT group: Intrusion</arm_group_label>
      <arm_group_label>LLLT group: distalization intervntion side</arm_group_label>
      <arm_group_label>LLLT group: leveling and alignment</arm_group_label>
      <arm_group_label>LLLT side canine retraction</arm_group_label>
      <arm_group_label>Lipus side: canine retraction</arm_group_label>
      <other_name>low intensity pulsed ultrasound</other_name>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          - A- leveling and alignment Eligibility criteria&#xD;
  &#xD;
          1. Age ranges from 14 to 17 years. 2. Bilateral Class II molar relationship. 3. Skeletal&#xD;
          Class I or mild Class II relationship. 4. Normal or decreased vertical height. 5. No&#xD;
          posterior crowding or spaces. 6. Fully erupted maxillary first and second molars. 7.&#xD;
          Congenitally missing or extracted third molars. 8. Good oral hygiene. 9. Absence of any&#xD;
          periodontal disease and alveolar bone loss. 10. Absence of medications that may inhibit&#xD;
          orthodontic movement&#xD;
  &#xD;
          Lower incisor leveling and alignment Inclusion criteria Complete permanent dentition (third&#xD;
          molars not included); Moderate mandibular anterior crowding (with little's irregularity&#xD;
          index score greater than 4 mm) who required non-extraction approach in the mandibular arch;&#xD;
          No tooth size, shape or root abnormalities visible on the patient's radiographic records;&#xD;
          No spaces in the mandibular arch; No blocked out tooth that did not allow for placement of&#xD;
          the bracket at the&#xD;
  &#xD;
          initial bonding appointment; 6. No required management with interproximal stripping,&#xD;
          inter-maxillary elastics, open NiTi springs, and removable or extra-oral devices. Canine&#xD;
          retraction Eligibility criteria&#xD;
  &#xD;
          Age, 15 to 25 years; Class ii division 1 malocclusion with mild or no crowding; No previous&#xD;
          orthodontic treatment; No systemic disease that might have affected bone formation or&#xD;
          density, such as osteoporosis, hyperparathyroidism, or vitamin d deficiency; Adequate oral&#xD;
          hygiene; Probing depth values not exceeding 3 mm across the Entire dentition; Adequate&#xD;
          thickness of the attached gingiva (1-2 mm); No radiographic evidence of bone loss&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
          - Patients who required surgery to correct skeletal discrepancies. Patients with congenital&#xD;
          dentoskeletal disorders. Missed or mutilated teeth in maxillary arch. Patients with poor&#xD;
          oral hygiene and/or periodontally compromised patients Severe dental crowding that&#xD;
          necessitates an extraction approach 2. Abnormal anteroposterior and vertical relationships;&#xD;
          3. Patients with cleft lip and palate, anomalies, and syndromes; 4. Previous orthodontic 5.&#xD;
          Treatment; 6. Regular medications intake that could interfere with otm. -&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>15 Years</minimum_age>
      <maximum_age>22 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <location>
      <facility>
        <name>AlAzhar university</name>
        <address>
          <city>Cairo</city>
          <country>Egypt</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Egypt</country>
    </location_countries>
    <results_reference>
      <citation>Maurya RK, Singh H, Kapoor P, Jain U, Mitra R. Effects of low-level laser and low-intensity pulsed ultrasound therapy on treatment duration and pain perception. J Clin Orthod. 2019 Mar;53(3):154-162. No abstract available.</citation>
      <PMID>31009384</PMID>
    </results_reference>
    <results_reference>
      <citation>El-Bialy T, Farouk K, Carlyle TD, Wiltshire W, Drummond R, Dumore T, Knowlton K, Tompson B. Effect of Low Intensity Pulsed Ultrasound (LIPUS) on Tooth Movement and Root Resorption: A Prospective Multi-Center Randomized Controlled Trial. J Clin Med. 2020 Mar 16;9(3):804. doi: 10.3390/jcm9030804.</citation>
      <PMID>32188053</PMID>
    </results_reference>
    <results_reference>
      <citation>Qamruddin I, Alam MK, Mahroof V, Karim M, Fida M, Khamis MF, Husein A. Biostimulatory Effects of Low-Intensity Pulsed Ultrasound on Rate of Orthodontic Tooth Movement and Associated Pain, Applied at 3-Week Intervals: A Split-Mouth Study. Pain Res Manag. 2021 May 5;2021:6624723. doi: 10.1155/2021/6624723. eCollection 2021.</citation>
      <PMID>34035871</PMID>
    </results_reference>
    <verification_date>September 2023</verification_date>
    <study_first_submitted>August 19, 2023</study_first_submitted>
    <study_first_submitted_qc>September 5, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">September 7, 2023</study_first_posted>
    <last_update_submitted>September 5, 2023</last_update_submitted>
    <last_update_submitted_qc>September 5, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">September 7, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Al-Azhar University</investigator_affiliation>
      <investigator_full_name>farouk ahmed hussein</investigator_full_name>
      <investigator_title>Principal Investigator</investigator_title>
    </responsible_party>
    <patient_data>
      <sharing_ipd>Yes</sharing_ipd>
    </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/NCT06026930
  org study id: 926/91
  nct id: NCT06026930
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The aim of this prospective clinical project will be to compare the effect of low-level laser
        therapy versus low intensity pulsed ultrasound on the rate of different orthodontic tooth
        movements
  The aim of this prospective clinical project will be to compare the effect of low-level laser
        therapy versus low intensity pulsed ultrasound on the rate of different orthodontic tooth
        movements, specifically; canine retraction, incisors' leveling and alignment, maxillary molar
        distalization, and incisors' intrusion
  allocation: Randomized
  intervention model: Factorial Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: Influence of low-level laser therapy versus low-intensity pulsed ultrasound on rate of different orthodontic tooth movements by millimeter
  time frame: post interventionalal at 6months
  description: rate of orthodontic tooth movement by millimeter
  arm group label: Lipus side: canine retraction
  arm group type: Experimental
  description: application of LIPUS with translation of maxillary canine that will be performed on intervention sides according to a standardized protocol
  arm group label: LIPUS side control side
  arm group type: No Intervention
  description: LIPUS side:canine retraction control side
  arm group label: LLLT side canine retraction
  arm group type: Experimental
  description: translation of maxillary canine that will be performed with LLLT application according to a standardized protocol
  arm group label: LLLT side canine retraction control side
  arm group type: No Intervention
  description: LLLT side canine retraction control side wihout intervention
  arm group label: LIPUS groupMolar distalization group inrervention side
  arm group type: Experimental
  description: distalization assisted with LIPUS according to a standardized protocol
  arm group label: LIPUS groupMolar distalization group control side
  arm group type: No Intervention
  description: distalization without LIPUS intervention
  arm group label: LLLT group: distalization intervntion side
  arm group type: Experimental
  description: distalization will be commenced with application of LLLT according to a standardized protocol
  arm group label: LLLT group: distalization control side
  arm group type: No Intervention
  description: distalization will be commenced without application of LLLT according to a standardized protocol
  arm group label: LIPUS group: leveling and alignment
  arm group type: Experimental
  description: leveling and alignment assisted with LIPUS according to a standardized protocol
  arm group label: LLLT group: leveling and alignment
  arm group type: Experimental
  description: leveling and alignment be commenced with application of LLLT according to a standardized protocol
  arm group label: leveling and alignment without intervention
  arm group type: No Intervention
  description: leveling and alignment without intervention
  arm group label: LIPUS group: Intrusion
  arm group type: Experimental
  description: intrusion assisted with LIPUS according to a standardized protocol
  arm group label: LLLT group: Intrusion
  arm group type: Experimental
  description: intrusion assisted with application of LLLT according to a standardized protocol
  arm group label: intrusion control group
  arm group type: No Intervention
  description: intrusion without intervention
  intervention type: Device
  intervention name: low-level laser therapy
  description: LLLT and LIPUS has been found to speed up OTM by stimulating the RANK/RANKL/OPG system to initiate osteoclast formation.
  arm group label: LIPUS group: Intrusion
  arm group label: LIPUS group: leveling and alignment
  arm group label: LIPUS groupMolar distalization group inrervention side
  arm group label: LLLT group: Intrusion
  arm group label: LLLT group: distalization intervntion side
  arm group label: LLLT group: leveling and alignment
  arm group label: LLLT side canine retraction
  arm group label: Lipus side: canine retraction
  other name: low intensity pulsed ultrasound
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 22 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Egypt
  citation: Maurya RK, Singh H, Kapoor P, Jain U, Mitra R. Effects of low-level laser and low-intensity pulsed ultrasound therapy on treatment duration and pain perception. J Clin Orthod. 2019 Mar;53(3):154-162. No abstract available.
  PMID: 31009384
  citation: El-Bialy T, Farouk K, Carlyle TD, Wiltshire W, Drummond R, Dumore T, Knowlton K, Tompson B. Effect of Low Intensity Pulsed Ultrasound (LIPUS) on Tooth Movement and Root Resorption: A Prospective Multi-Center Randomized Controlled Trial. J Clin Med. 2020 Mar 16;9(3):804. doi: 10.3390/jcm9030804.
  PMID: 32188053
  citation: Qamruddin I, Alam MK, Mahroof V, Karim M, Fida M, Khamis MF, Husein A. Biostimulatory Effects of Low-Intensity Pulsed Ultrasound on Rate of Orthodontic Tooth Movement and Associated Pain, Applied at 3-Week Intervals: A Split-Mouth Study. Pain Res Manag. 2021 May 5;2021:6624723. doi: 10.1155/2021/6624723. eCollection 2021.
  PMID: 34035871
  responsible party type: Principal Investigator
  investigator affiliation: Al-Azhar University
  investigator full name: farouk ahmed hussein
  investigator title: Principal Investigator
  sharing ipd: Yes