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/NCT05988723</url>
    </required_header>
    <id_info>
      <org_study_id>DHF-21006</org_study_id>
      <nct_id>NCT05988723</nct_id>
    </id_info>
    <brief_title>Evaluation of the Effects of Obesity on Orthodontic Tooth Movement</brief_title>
    <official_title>Evaluation of the Effects of Obesity on Orthodontic Tooth Movement</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Aydin Adnan Menderes University</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Aydin Adnan Menderes University</source>
    <oversight_info>
      <has_dmc>Yes</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>
        In this study, bone remodeling in the gingival crevicular fluid was evaluated biochemically&#xD;
        during canine distalization in obese individuals and compared with normal weight individuals.&#xD;
        At the same time, the speed of tooth movement was measured in obese individuals and compared&#xD;
        with normal weight individuals.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        Among the obese and normal weight patients who applied to Aydın Adnan Menderes University&#xD;
        Faculty of Dentistry Department of Orthodontics for orthodontic treatment, those who met the&#xD;
        inclusion criteria were selected for the study. Patients with Angle Class II malocclusion who&#xD;
        required extraction of the maxillary first premolar tooth were included in the study. Obesity&#xD;
        classification, as the World Health Organization (WHO) determines the obesity values in&#xD;
        children; BMI values; &lt;5% very thin, 5%-15% underweight, 16-85% normal, 86-95% overweight,&#xD;
        and ≥95% obese. Percentile values were calculated with reference to the study &quot;Reference&#xD;
        Values for Weight, Height, Head Circumference, and Body Mass Index in Turkish Children&quot;&#xD;
        conducted by Neyzi et al. (2015). In our study, individuals with normal weight and without&#xD;
        any systemic disease were determined as the control group, and individuals without any&#xD;
        systemic disease other than obesity were determined as the study group. Leptin, IL-6, OPG and&#xD;
        RANKL levels were measured in gingival sulcus fluid samples taken from the distal gingival&#xD;
        groove of obese and healthy individuals who underwent canine distalization. Roth metal&#xD;
        brackets and tubes with 0.022 inch slots were used for the fixed orthodontic treatment of the&#xD;
        patients. After leveling the teeth of the patients with arch wires, it was waited for 2&#xD;
        months in 19x25 stainless steel arch wire and then 150 gr distalization force was applied.&#xD;
        DOS samples were taken from the distal gingival groove of teeth on day 7 (T2), day 14 (T3)&#xD;
        and day 21 (T4), just before distalization force was applied (T0), 24 hours after force was&#xD;
        applied (T1). In order to determine the speed of tooth movement, the patient's mouth was&#xD;
        scanned on the days of DOS (T0, T1, T2, T3, T4) and in addition to these days, on the 28th&#xD;
        day (T5) and at the end of the 3rd month (T6), with the 3shape Trios device and using the&#xD;
        OrthoAnalyzer software. The amount of movement of the canine tooth was measured in mm. Before&#xD;
        collecting the gingival groove fluid sample, the area was isolated with cotton rolls, and the&#xD;
        adjacent teeth and marginal gingival area were air-dried. The Periopaper was then gently&#xD;
        placed in the gingival sulci below the gingival margin for 30 seconds. Paper strips were&#xD;
        individually sealed in eppendorf tubes and each sample was stored at -80°C until later&#xD;
        analysis. Leptin, IL-6, OPG and RANKL levels were examined with Elisa kits from the samples&#xD;
        obtained. The planned period for the study was determined as 3 months in total.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">April 15, 2021</start_date>
    <completion_date type="Actual">February 13, 2023</completion_date>
    <primary_completion_date type="Actual">January 16, 2023</primary_completion_date>
    <study_type>Observational [Patient Registry]</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <observational_model>Cohort</observational_model>
      <time_perspective>Prospective</time_perspective>
    </study_design_info>
    <target_duration>3 Months</target_duration>
    <primary_outcome>
      <measure>Leptin, RANKL, OPG and IL-6 ELISA kits</measure>
      <time_frame>The change in biomarker levels will be measured over a 1-month period.</time_frame>
      <description>ELISA kits were used to measure the biomarker level in gingival crevicular fluid samples taken from the patient.</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Correlation between leptin level and tooth movement speed</measure>
      <time_frame>It will be examined whether there is a relationship between leptin level and tooth movement speed over a 21-day period.</time_frame>
      <description>3D intraoral scanner and leptin elisa kit will be used</description>
    </primary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">36</enrollment>
    <condition>Obesity, Childhood</condition>
    <condition>Orthodontic Treatment</condition>
    <arm_group>
      <arm_group_label>Study Group (obese patient)</arm_group_label>
      <description>Leptin, IL-6, OPG, RANKL levels were measured in samples taken from the distal gingival groove of the canine teeth of obese individuals. Roth metal brackets and tubes with 0.022 inch slots were used for the fixed orthodontic treatment of the patients. After leveling the teeth of the patients with arch wires, it was waited for 2 months in 19x25 stainless steel arch wire and then 150 gr distalization force was applied. DOS samples were taken from the distal gingival groove of teeth on day 7 (T2), day 14 (T3) and day 21 (T4), just before distalization force was applied (T0), 24 hours after force was applied (T1). In order to determine the speed of tooth movement, the patient's mouth was scanned on the days when DOS was taken (T0,T1,T2,T3,T4) and in addition to these days, on the 28th day (T5) and at the end of the 3rd month (T6), and the amount of movement of the canine tooth was measured in mm. Leptin, IL-6, OPG, RANKL levels were examined with Elisa kits from the samples obtained.</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Control Group (normal patient)</arm_group_label>
      <description>Leptin, IL-6, OPG, RANKL levels were measured in samples taken from the distal gingival groove of the canine teeth of normal weight individuals.Roth metal brackets and tubes with 0.022 inch slots were used for the fixed orthodontic treatment of the patients.After leveling the teeth of the patients with arch wires, it was waited for 2 months in 19x25 stainless steel arch wire and then 150 gr distalization force was applied.DOS samples were taken from the distal gingival groove of teeth on day 7 (T2), day 14 (T3) and day 21 (T4), just before distalization force was applied (T0), 24 hours after force was applied (T1). In order to determine the speed of tooth movement, the patient's mouth was scanned on the days when DOS was taken (T0,T1,T2,T3,T4) and in addition to these days, on the 28th day (T5) and at the end of the 3rd month (T6), and the amount of movement of the canine tooth was measured in mm. Leptin, IL-6, OPG, RANKL levels were examined with Elisa kits from the samples obtained.</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>ELISA kits</intervention_name>
      <description>Making biochemical measurements with the ELISA kit</description>
      <arm_group_label>Control Group (normal patient)</arm_group_label>
      <arm_group_label>Study Group (obese patient)</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Men and women patients aged between 12-18 years who have continued orthodontic treatmens&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Body mass index ≥ 95% for obese individuals, body mass index between 16-85% for normal&#xD;
               weight individuals,&#xD;
  &#xD;
            -  Absence of any systemic disease that may affect tooth movement,&#xD;
  &#xD;
            -  Premolar tooth extraction is required because the patients have Angle Class II&#xD;
               malocclusion,&#xD;
  &#xD;
            -  No history of orthodontic treatment,&#xD;
  &#xD;
            -  No anti-inflammatory drug use within 1 month before starting the study,&#xD;
  &#xD;
            -  No signs of gingivitis or a history of periodontal treatment,&#xD;
  &#xD;
            -  To have good periodontal health,&#xD;
  &#xD;
            -  The patients are in the permanent dentition period,&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  History of previous orthodontic treatment,&#xD;
  &#xD;
            -  Anti-inflammatory drug use within 1 month before starting the study,&#xD;
  &#xD;
            -  To have signs of gingivitis or a history of periodontal treatment,&#xD;
  &#xD;
            -  Individuals with poor periodontal health,&#xD;
  &#xD;
            -  Individuals in the mixed dentition period,&#xD;
  &#xD;
            -  Individuals who have smoking or alcohol habits,&#xD;
  &#xD;
            -  Determined as patient non-compliance.&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>12 Years</minimum_age>
      <maximum_age>18 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Mine Geçgelen Cesur</last_name>
      <role>Study Director</role>
      <affiliation>Aydin Adnan Menderes University</affiliation>
    </overall_official>
    <location>
      <facility>
        <name>Aydın Adnan Menderes University Faculty of Dentistry</name>
        <address>
          <city>Aydın</city>
          <zip>09100</zip>
          <country>Turkey</country>
        </address>
      </facility>
    </location>
    <location_countries>
      <country>Turkey</country>
    </location_countries>
    <results_reference>
      <citation>Dilsiz A, Kilic N, Aydin T, Ates FN, Zihni M, Bulut C. Leptin levels in gingival crevicular fluid during orthodontic tooth movement. Angle Orthod. 2010 May;80(3):504-8. doi: 10.2319/072109-402.1.</citation>
      <PMID>20050744</PMID>
    </results_reference>
    <results_reference>
      <citation>Neyzi O, Bundak R, Gokcay G, Gunoz H, Furman A, Darendeliler F, Bas F. Reference Values for Weight, Height, Head Circumference, and Body Mass Index in Turkish Children. J Clin Res Pediatr Endocrinol. 2015 Dec;7(4):280-93. doi: 10.4274/jcrpe.2183.</citation>
      <PMID>26777039</PMID>
    </results_reference>
    <results_reference>
      <citation>Jayachandran T, Srinivasan B, Padmanabhan S. Salivary leptin levels in normal weight and overweight individuals and their correlation with orthodontic tooth movement. Angle Orthod. 2017 Sep;87(5):739-744. doi: 10.2319/120216-869.1. Epub 2017 May 4.</citation>
      <PMID>28471265</PMID>
    </results_reference>
    <results_reference>
      <citation>Saloom HF, Boustan R, Seehra J, Papageorgiou SN, Carpenter GH, Cobourne MT. The impact of obesity on orthodontic treatment outcome in adolescents: a prospective clinical cohort study. Eur J Orthod. 2021 Apr 3;43(2):165-172. doi: 10.1093/ejo/cjaa032.</citation>
      <PMID>32390057</PMID>
    </results_reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>June 2, 2023</study_first_submitted>
    <study_first_submitted_qc>August 9, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 14, 2023</study_first_posted>
    <last_update_submitted>August 9, 2023</last_update_submitted>
    <last_update_submitted_qc>August 9, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 14, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Principal Investigator</responsible_party_type>
      <investigator_affiliation>Aydin Adnan Menderes University</investigator_affiliation>
      <investigator_full_name>Mustafa UZUN</investigator_full_name>
      <investigator_title>Research Assistant</investigator_title>
    </responsible_party>
    <keyword>Obesity</keyword>
    <keyword>Orthodontic Treatment</keyword>
    <keyword>Tooth movement</keyword>
    <keyword>Biomarkers</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Obesity</mesh_term>
      <mesh_term>Pediatric Obesity</mesh_term>
    </condition_browse>
    <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/NCT05988723
  org study id: DHF-21006
  nct id: NCT05988723
  lead sponsor: 
  has dmc: Yes
  is fda regulated drug: No
  is fda regulated device: No
  In this study, bone remodeling in the gingival crevicular fluid was evaluated biochemically
        during canine distalization in obese individuals and compared with normal weight individuals.
        At the same time, the speed of tooth movement was measured in obese individuals and compared
        with normal weight individuals.
  Among the obese and normal weight patients who applied to Aydın Adnan Menderes University
        Faculty of Dentistry Department of Orthodontics for orthodontic treatment, those who met the
        inclusion criteria were selected for the study. Patients with Angle Class II malocclusion who
        required extraction of the maxillary first premolar tooth were included in the study. Obesity
        classification, as the World Health Organization (WHO) determines the obesity values in
        children; BMI values; <5% very thin, 5%-15% underweight, 16-85% normal, 86-95% overweight,
        and ≥95% obese. Percentile values were calculated with reference to the study "Reference
        Values for Weight, Height, Head Circumference, and Body Mass Index in Turkish Children"
        conducted by Neyzi et al. (2015). In our study, individuals with normal weight and without
        any systemic disease were determined as the control group, and individuals without any
        systemic disease other than obesity were determined as the study group. Leptin, IL-6, OPG and
        RANKL levels were measured in gingival sulcus fluid samples taken from the distal gingival
        groove of obese and healthy individuals who underwent canine distalization. Roth metal
        brackets and tubes with 0.022 inch slots were used for the fixed orthodontic treatment of the
        patients. After leveling the teeth of the patients with arch wires, it was waited for 2
        months in 19x25 stainless steel arch wire and then 150 gr distalization force was applied.
        DOS samples were taken from the distal gingival groove of teeth on day 7 (T2), day 14 (T3)
        and day 21 (T4), just before distalization force was applied (T0), 24 hours after force was
        applied (T1). In order to determine the speed of tooth movement, the patient's mouth was
        scanned on the days of DOS (T0, T1, T2, T3, T4) and in addition to these days, on the 28th
        day (T5) and at the end of the 3rd month (T6), with the 3shape Trios device and using the
        OrthoAnalyzer software. The amount of movement of the canine tooth was measured in mm. Before
        collecting the gingival groove fluid sample, the area was isolated with cotton rolls, and the
        adjacent teeth and marginal gingival area were air-dried. The Periopaper was then gently
        placed in the gingival sulci below the gingival margin for 30 seconds. Paper strips were
        individually sealed in eppendorf tubes and each sample was stored at -80°C until later
        analysis. Leptin, IL-6, OPG and RANKL levels were examined with Elisa kits from the samples
        obtained. The planned period for the study was determined as 3 months in total.
  observational model: Cohort
  time perspective: Prospective
  measure: Leptin, RANKL, OPG and IL-6 ELISA kits
  time frame: The change in biomarker levels will be measured over a 1-month period.
  description: ELISA kits were used to measure the biomarker level in gingival crevicular fluid samples taken from the patient.
  measure: Correlation between leptin level and tooth movement speed
  time frame: It will be examined whether there is a relationship between leptin level and tooth movement speed over a 21-day period.
  description: 3D intraoral scanner and leptin elisa kit will be used
  arm group label: Study Group (obese patient)
  description: Leptin, IL-6, OPG, RANKL levels were measured in samples taken from the distal gingival groove of the canine teeth of obese individuals. Roth metal brackets and tubes with 0.022 inch slots were used for the fixed orthodontic treatment of the patients. After leveling the teeth of the patients with arch wires, it was waited for 2 months in 19x25 stainless steel arch wire and then 150 gr distalization force was applied. DOS samples were taken from the distal gingival groove of teeth on day 7 (T2), day 14 (T3) and day 21 (T4), just before distalization force was applied (T0), 24 hours after force was applied (T1). In order to determine the speed of tooth movement, the patient's mouth was scanned on the days when DOS was taken (T0,T1,T2,T3,T4) and in addition to these days, on the 28th day (T5) and at the end of the 3rd month (T6), and the amount of movement of the canine tooth was measured in mm. Leptin, IL-6, OPG, RANKL levels were examined with Elisa kits from the samples obtained.
  arm group label: Control Group (normal patient)
  description: Leptin, IL-6, OPG, RANKL levels were measured in samples taken from the distal gingival groove of the canine teeth of normal weight individuals.Roth metal brackets and tubes with 0.022 inch slots were used for the fixed orthodontic treatment of the patients.After leveling the teeth of the patients with arch wires, it was waited for 2 months in 19x25 stainless steel arch wire and then 150 gr distalization force was applied.DOS samples were taken from the distal gingival groove of teeth on day 7 (T2), day 14 (T3) and day 21 (T4), just before distalization force was applied (T0), 24 hours after force was applied (T1). In order to determine the speed of tooth movement, the patient's mouth was scanned on the days when DOS was taken (T0,T1,T2,T3,T4) and in addition to these days, on the 28th day (T5) and at the end of the 3rd month (T6), and the amount of movement of the canine tooth was measured in mm. Leptin, IL-6, OPG, RANKL levels were examined with Elisa kits from the samples obtained.
  intervention type: Other
  intervention name: ELISA kits
  description: Making biochemical measurements with the ELISA kit
  arm group label: Control Group (normal patient)
  arm group label: Study Group (obese patient)
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: All
  minimum age: 12 Years
  maximum age: 18 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Mine Geçgelen Cesur
  role: Study Director
  affiliation: Aydin Adnan Menderes University
  facility: 
  country: Turkey
  citation: Dilsiz A, Kilic N, Aydin T, Ates FN, Zihni M, Bulut C. Leptin levels in gingival crevicular fluid during orthodontic tooth movement. Angle Orthod. 2010 May;80(3):504-8. doi: 10.2319/072109-402.1.
  PMID: 20050744
  citation: Neyzi O, Bundak R, Gokcay G, Gunoz H, Furman A, Darendeliler F, Bas F. Reference Values for Weight, Height, Head Circumference, and Body Mass Index in Turkish Children. J Clin Res Pediatr Endocrinol. 2015 Dec;7(4):280-93. doi: 10.4274/jcrpe.2183.
  PMID: 26777039
  citation: Jayachandran T, Srinivasan B, Padmanabhan S. Salivary leptin levels in normal weight and overweight individuals and their correlation with orthodontic tooth movement. Angle Orthod. 2017 Sep;87(5):739-744. doi: 10.2319/120216-869.1. Epub 2017 May 4.
  PMID: 28471265
  citation: Saloom HF, Boustan R, Seehra J, Papageorgiou SN, Carpenter GH, Cobourne MT. The impact of obesity on orthodontic treatment outcome in adolescents: a prospective clinical cohort study. Eur J Orthod. 2021 Apr 3;43(2):165-172. doi: 10.1093/ejo/cjaa032.
  PMID: 32390057
  responsible party type: Principal Investigator
  investigator affiliation: Aydin Adnan Menderes University
  investigator full name: Mustafa UZUN
  investigator title: Research Assistant
  mesh term: Obesity
  mesh term: Pediatric Obesity
  sharing ipd: No