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/NCT05966987</url>
    </required_header>
    <id_info>
      <org_study_id>923/91</org_study_id>
      <nct_id>NCT05966987</nct_id>
    </id_info>
    <brief_title>Assessment of Different Orthodontic Tooth Movements Assisted With Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin</brief_title>
    <official_title>Assessment of Different Orthodontic Tooth Movements Assisted With Low-level Laser Therapy vs. Injectable Plasma-rich Fibrin: 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 present prospective clinical study will be undertaken for assessment of the effect of&#xD;
        application of Injectable plasma-rich fibrin versus Low-Level Laser Therapy onthe rate of&#xD;
        different orthodontic tooth movements,&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The present prospective clinical study will be undertaken for assessment of the effect of&#xD;
        application of Inject able plasma-rich fibrin versus Low-Level Laser Therapy on the rate of&#xD;
        different orthodontic tooth movements, namely: canine retraction, mandibular incisors&#xD;
        leveling and alignment, maxillary molar distalization and maxillary incisor intrusion.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Enrolling by invitation</overall_status>
    <start_date type="Anticipated">August 2023</start_date>
    <completion_date type="Anticipated">September 2024</completion_date>
    <primary_completion_date type="Anticipated">February 2024</primary_completion_date>
    <phase>Phase 1</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>
      <intervention_model_description>Factorial Assignment</intervention_model_description>
      <primary_purpose>Basic Science</primary_purpose>
      <masking>None (Open Label)</masking>
    </study_design_info>
    <primary_outcome>
      <measure>assessment of the effect of application of Injectable plasma-rich fibrin versus Low-Level Laser Therapy on the accelration rate of different orthodontic tooth movements by millimeter</measure>
      <time_frame>6 months</time_frame>
    </primary_outcome>
    <number_of_arms>14</number_of_arms>
    <enrollment type="Anticipated">82</enrollment>
    <condition>Injectable Plasma-rich Fibrin Versus Low-Level Laser Therapy on Othodontic Movement</condition>
    <arm_group>
      <arm_group_label>i-PRF side: canine retraction</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>application of i-PRF 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>i-prf side control side</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>i-PRF 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>I-PRF groupMolar distalization group inrervention side</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>Idistalization assisted with Injectable platelet-rich fibrin (i-PRF) according to a standardized protocol</description>
    </arm_group>
    <arm_group>
      <arm_group_label>I-PRF groupMolar distalization group control side</arm_group_label>
      <arm_group_type>No Intervention</arm_group_type>
      <description>distalization without i-PRF 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>i-PRF group: leveling and alignment</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>leveling and alignment assisted with Injectable platelet-rich fibrin (i-PRF) 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>I-PRF group: Intrusion</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>intrusion assisted with Injectable platelet-rich fibrin (i-PRF) 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>Combination Product</intervention_type>
      <intervention_name>Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin</intervention_name>
      <description>laser and platelet rich fibrin</description>
      <arm_group_label>I-PRF group: Intrusion</arm_group_label>
      <arm_group_label>I-PRF 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>i-PRF group: leveling and alignment</arm_group_label>
      <arm_group_label>i-PRF side: canine retraction</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
          A- leveling and alignment Eligibility criteria&#xD;
  &#xD;
            1. Complete permanent dentition (third molars not included).&#xD;
  &#xD;
            2. Moderate mandibular anterior crowding (with Little's irregularity index score greater&#xD;
               than 4 mm) who required nonextraction approach in the mandibular arch.&#xD;
  &#xD;
            3. No tooth size, shape or root abnormalities visible on patient's radiographic records.&#xD;
  &#xD;
            4. No spaces in the mandibular arch.&#xD;
  &#xD;
            5. No blocked out tooth that did not allow for placement of the bracket at the initial&#xD;
               bonding appointment.&#xD;
  &#xD;
            6. No required management with interproximal stripping, intermaxillary elastics, open&#xD;
               NiTi springs, and removable or extra-oral devices. Maxillary molar distalization&#xD;
               Inclusion 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&#xD;
  &#xD;
                 1. Complete permanent dentition (third molars not included);&#xD;
  &#xD;
                 2. Moderate mandibular anterior crowding (with little's irregularity index score&#xD;
                    greater than 4 mm) who required non-extraction approach in the mandibular arch;&#xD;
  &#xD;
                 3. No tooth size, shape or root abnormalities visible on the patient's radiographic&#xD;
                    records;&#xD;
  &#xD;
                 4. No spaces in the mandibular arch;&#xD;
  &#xD;
                 5. No blocked out tooth that did not allow for placement of 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;
            1. Age, 15 to 25 years;&#xD;
  &#xD;
            2. Class ii division 1 malocclusion with mild or no crowding;&#xD;
  &#xD;
            3. No previous orthodontic treatment;&#xD;
  &#xD;
            4. No systemic disease that might have affected bone formation or density, such as&#xD;
               osteoporosis, hyperparathyroidism, or vitamin d deficiency;&#xD;
  &#xD;
            5. Adequate oral hygiene;&#xD;
  &#xD;
            6. Probing depth values not exceeding 3 mm across the&#xD;
  &#xD;
            7. Entire dentition;&#xD;
  &#xD;
            8. Adequate thickness of the attached gingiva (1-2 mm);&#xD;
  &#xD;
            9. No radiographic evidence of bone loss&#xD;
  &#xD;
          Exclusion Criteria:Exclusion criteria:&#xD;
  &#xD;
            1. Patients who required surgery to correct skeletal discrepancies.&#xD;
  &#xD;
            2. Patients with congenital dentoskeletal disorders.&#xD;
  &#xD;
            3. Missed or mutilated teeth in maxillary arch.&#xD;
  &#xD;
            4. Patients with poor oral hygiene and/or periodontally compromised patients Severe&#xD;
               dental crowding that necessitates an extraction approach 2. Abnormal anteroposterior&#xD;
               and vertical relationships; 3. Patients with cleft lip and palate, anomalies, and&#xD;
               syndromes; 4. Previous orthodontic 5. Treatment; 6. Regular medications intake that&#xD;
               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>
    <reference>
      <citation>Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Three-dimensional evaluation of the effects of injectable platelet rich fibrin (i-PRF) on alveolar bone and root length during orthodontic treatment: a randomized split mouth trial. BMC Oral Health. 2021 Mar 2;21(1):92. doi: 10.1186/s12903-021-01456-9.</citation>
      <PMID>33653326</PMID>
    </reference>
    <results_reference>
      <citation>Youssef M, Ashkar S, Hamade E, Gutknecht N, Lampert F, Mir M. The effect of low-level laser therapy during orthodontic movement: a preliminary study. Lasers Med Sci. 2008 Jan;23(1):27-33. doi: 10.1007/s10103-007-0449-7. Epub 2007 Mar 15.</citation>
      <PMID>17361391</PMID>
    </results_reference>
    <verification_date>July 2023</verification_date>
    <study_first_submitted>July 20, 2023</study_first_submitted>
    <study_first_submitted_qc>July 28, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 1, 2023</study_first_posted>
    <last_update_submitted>July 28, 2023</last_update_submitted>
    <last_update_submitted_qc>July 28, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 1, 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>No</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/NCT05966987
  org study id: 923/91
  nct id: NCT05966987
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The present prospective clinical study will be undertaken for assessment of the effect of
        application of Injectable plasma-rich fibrin versus Low-Level Laser Therapy onthe rate of
        different orthodontic tooth movements,
  The present prospective clinical study will be undertaken for assessment of the effect of
        application of Inject able plasma-rich fibrin versus Low-Level Laser Therapy on the rate of
        different orthodontic tooth movements, namely: canine retraction, mandibular incisors
        leveling and alignment, maxillary molar distalization and maxillary incisor intrusion.
  allocation: Randomized
  intervention model: Factorial Assignment
  intervention model description: Factorial Assignment
  primary purpose: Basic Science
  masking: None (Open Label)
  measure: assessment of the effect of application of Injectable plasma-rich fibrin versus Low-Level Laser Therapy on the accelration rate of different orthodontic tooth movements by millimeter
  time frame: 6 months
  arm group label: i-PRF side: canine retraction
  arm group type: Experimental
  description: application of i-PRF with translation of maxillary canine that will be performed on intervention sides according to a standardized protocol
  arm group label: i-prf side control side
  arm group type: No Intervention
  description: i-PRF 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: I-PRF groupMolar distalization group inrervention side
  arm group type: Experimental
  description: Idistalization assisted with Injectable platelet-rich fibrin (i-PRF) according to a standardized protocol
  arm group label: I-PRF groupMolar distalization group control side
  arm group type: No Intervention
  description: distalization without i-PRF 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: i-PRF group: leveling and alignment
  arm group type: Experimental
  description: leveling and alignment assisted with Injectable platelet-rich fibrin (i-PRF) 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: I-PRF group: Intrusion
  arm group type: Experimental
  description: intrusion assisted with Injectable platelet-rich fibrin (i-PRF) 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: Combination Product
  intervention name: Low-level Laser Therapy vs. Injectable Platelets-rich Fibrin
  description: laser and platelet rich fibrin
  arm group label: I-PRF group: Intrusion
  arm group label: I-PRF 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: i-PRF group: leveling and alignment
  arm group label: i-PRF side: canine retraction
  criteria: 
  gender: All
  minimum age: 15 Years
  maximum age: 22 Years
  healthy volunteers: Accepts Healthy Volunteers
  facility: 
  country: Egypt
  citation: Zeitounlouian TS, Zeno KG, Brad BA, Haddad RA. Three-dimensional evaluation of the effects of injectable platelet rich fibrin (i-PRF) on alveolar bone and root length during orthodontic treatment: a randomized split mouth trial. BMC Oral Health. 2021 Mar 2;21(1):92. doi: 10.1186/s12903-021-01456-9.
  PMID: 33653326
  citation: Youssef M, Ashkar S, Hamade E, Gutknecht N, Lampert F, Mir M. The effect of low-level laser therapy during orthodontic movement: a preliminary study. Lasers Med Sci. 2008 Jan;23(1):27-33. doi: 10.1007/s10103-007-0449-7. Epub 2007 Mar 15.
  PMID: 17361391
  responsible party type: Principal Investigator
  investigator affiliation: Al-Azhar University
  investigator full name: farouk ahmed hussein
  investigator title: Principal Investigator
  sharing ipd: No