<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/NCT04452071</url>
  </required_header>
  <id_info>
    <org_study_id>GCF ALP skeletal indicator</org_study_id>
    <nct_id>NCT04452071</nct_id>
  </id_info>
  <brief_title>Gingival Crevicular Fluid Alkaline Phosphatase as Skeletal Growth Indicator</brief_title>
  <official_title>Gingival Crevicular Fluid Alkaline Phosphatase Activity as a Biomarker of Skeletal Maturation in Comparison to Modified Middle Phalanx of The Middle Finger (MP3) Method in a Sample of Growing Egyptian Females</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo University</source>
  <oversight_info>
    <is_fda_regulated_drug>No</is_fda_regulated_drug>
    <is_fda_regulated_device>No</is_fda_regulated_device>
  </oversight_info>
  <brief_summary>
    <textblock>
      Determination of the pubertal growth spurt in Egyptian female patients using gingival&#xD;
      crevicular fluid alkaline phosphatase&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      assessment of the pubertal growth spurt in growing Egyptian female patients by using a&#xD;
      simple, quick and easy method, through taking a gingival crevicular fluid alkaline&#xD;
      phosphatase sample and measuring its concentration. Comparing the concentration of GCF ALP to&#xD;
      the standardized middle phalanax of the middle finger MP3 we can predict if it can be an&#xD;
      accurate and reliable method as skeletal growth indicator.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">November 26, 2019</start_date>
  <completion_date type="Actual">January 10, 2020</completion_date>
  <primary_completion_date type="Actual">December 17, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Cohort</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>GCF ALP concentration</measure>
    <time_frame>immediately after sample collection</time_frame>
    <description>concentration of gingival crevicular fluid alkaline phosphatase</description>
  </primary_outcome>
  <primary_outcome>
    <measure>MP3</measure>
    <time_frame>immediately after taking x-rays</time_frame>
    <description>periapical x-ray of the middle phalanax of the middle finger</description>
  </primary_outcome>
  <number_of_groups>3</number_of_groups>
  <enrollment type="Actual">92</enrollment>
  <condition>Growth Indictaor</condition>
  <arm_group>
    <arm_group_label>prepubertal</arm_group_label>
    <description>patients born in 2012-2011</description>
  </arm_group>
  <arm_group>
    <arm_group_label>pubertal</arm_group_label>
    <description>patients born in 2010-2009-2008-2007</description>
  </arm_group>
  <arm_group>
    <arm_group_label>postpubertal</arm_group_label>
    <description>patients born in 2006-2005-2004-2003</description>
  </arm_group>
  <intervention>
    <intervention_type>Radiation</intervention_type>
    <intervention_name>periapical xray</intervention_name>
    <description>periapical xray on the middle phalanax of the middle finger</description>
    <arm_group_label>postpubertal</arm_group_label>
    <arm_group_label>prepubertal</arm_group_label>
    <arm_group_label>pubertal</arm_group_label>
  </intervention>
  <eligibility>
    <study_pop>
      <textblock>
        Egyptian female patients with age range from 7 to 16 years old&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Non-Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Gender: only female subjects will be included.&#xD;
&#xD;
          2. Age between 7-16 years old&#xD;
&#xD;
          3. Intermediate or late mixed dentition and permanent dentition&#xD;
&#xD;
          4. Good general health with absence of any nutritional problems or bony disease&#xD;
&#xD;
          5. No usage of any anti-inflammatories or antibiotics in the month preceding the study&#xD;
&#xD;
          6. Fully erupted upper and lower central incisors for sample collection&#xD;
&#xD;
          7. Good gingival and periodontal health as indicated by Probing depth (PD) values that&#xD;
             should not exceed 3 mm for the whole dentition.&#xD;
&#xD;
          8. Willingness to participate in the study and sign the informed consent form&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Male adolescent subjects&#xD;
&#xD;
          2. Periodontal and /or gingival disease&#xD;
&#xD;
          3. Systemic and/or bone disease&#xD;
&#xD;
        3. Growth abnormality&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <gender_based>Yes</gender_based>
    <gender_description>self representation of gender identity</gender_description>
    <minimum_age>7 Years</minimum_age>
    <maximum_age>16 Years</maximum_age>
  </eligibility>
  <location>
    <facility>
      <name>Faculty of Dentistry</name>
      <address>
        <city>Cairo</city>
        <state>Manial</state>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Perinetti G, Baccetti T, Contardo L, Di Lenarda R. Gingival crevicular fluid alkaline phosphatase activity as a non-invasive biomarker of skeletal maturation. Orthod Craniofac Res. 2011 Feb;14(1):44-50. doi: 10.1111/j.1601-6343.2010.01506.x. Epub 2010 Nov 23.</citation>
    <PMID>21205168</PMID>
  </reference>
  <verification_date>June 2020</verification_date>
  <study_first_submitted>June 26, 2020</study_first_submitted>
  <study_first_submitted_qc>June 26, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">June 30, 2020</study_first_posted>
  <last_update_submitted>June 26, 2020</last_update_submitted>
  <last_update_submitted_qc>June 26, 2020</last_update_submitted_qc>
  <last_update_posted type="Actual">June 30, 2020</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>sarah samir abdelrahman abelmaged</investigator_full_name>
    <investigator_title>doctor</investigator_title>
  </responsible_party>
  <!-- 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/NCT04452071
org study id: GCF ALP skeletal indicator
nct id: NCT04452071
lead sponsor: 
is fda regulated drug: No
is fda regulated device: No
Determination of the pubertal growth spurt in Egyptian female patients using gingival
      crevicular fluid alkaline phosphatase
assessment of the pubertal growth spurt in growing Egyptian female patients by using a
      simple, quick and easy method, through taking a gingival crevicular fluid alkaline
      phosphatase sample and measuring its concentration. Comparing the concentration of GCF ALP to
      the standardized middle phalanax of the middle finger MP3 we can predict if it can be an
      accurate and reliable method as skeletal growth indicator.
observational model: Cohort
time perspective: Cross-Sectional
measure: GCF ALP concentration
time frame: immediately after sample collection
description: concentration of gingival crevicular fluid alkaline phosphatase
measure: MP3
time frame: immediately after taking x-rays
description: periapical x-ray of the middle phalanax of the middle finger
arm group label: prepubertal
description: patients born in 2012-2011
arm group label: pubertal
description: patients born in 2010-2009-2008-2007
arm group label: postpubertal
description: patients born in 2006-2005-2004-2003
intervention type: Radiation
intervention name: periapical xray
description: periapical xray on the middle phalanax of the middle finger
arm group label: postpubertal
arm group label: prepubertal
arm group label: pubertal
study pop: 
sampling method: Non-Probability Sample
criteria: 
gender: Female
gender based: Yes
gender description: self representation of gender identity
minimum age: 7 Years
maximum age: 16 Years
facility: 
country: Egypt
citation: Perinetti G, Baccetti T, Contardo L, Di Lenarda R. Gingival crevicular fluid alkaline phosphatase activity as a non-invasive biomarker of skeletal maturation. Orthod Craniofac Res. 2011 Feb;14(1):44-50. doi: 10.1111/j.1601-6343.2010.01506.x. Epub 2010 Nov 23.
PMID: 21205168
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: sarah samir abdelrahman abelmaged
investigator title: doctor