<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/NCT04478864</url>
  </required_header>
  <id_info>
    <org_study_id>Esraa2020</org_study_id>
    <nct_id>NCT04478864</nct_id>
  </id_info>
  <brief_title>Knowledge, Practice and State of Periodontal Health</brief_title>
  <official_title>Assessment of Knowledge, Practice and State of Periodontal Health Among Egyptian Patients Attending Diagnostic Center at Faculty of Dentistry, Cairo University. A Cross-sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Noha Ayman Ghallab</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      The main objective of the study is to assess the knowledge and practice of periodontal&#xD;
      health, which will be done using a well constructed and validated questionnaire. Then&#xD;
      periodontal health status of all participants will be assessed via clinical examination of&#xD;
      certain teeth.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      The primary outcome of the study is the knowledge of periodontal health.It will be assessed&#xD;
      by 10 questions focusing on the basic knowledge of gingival appearance, causes and&#xD;
      consequence of periodontal disease, impact of systemic disease on the progression of&#xD;
      periodontal conditions, and prevention. Then, periodontal practice will be addressed via&#xD;
      several questions that evaluate the self-care practices of tooth brushing, flossing, mouth&#xD;
      rinsing in recent one year, scaling in recent five years, and how to alleviate gingival&#xD;
      bleeding if there is.&#xD;
&#xD;
      Periodontal examination using the community periodontal index (CPI) will be done for all of&#xD;
      the participants to assess the status of periodontal condition. The dentition will be divided&#xD;
      into sextants and the highest code number corresponding to the worst periodontal condition&#xD;
      around each of the 10 indexed teeth being recorded.&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Completed</overall_status>
  <start_date type="Actual">September 27, 2020</start_date>
  <completion_date type="Actual">November 30, 2021</completion_date>
  <primary_completion_date type="Actual">October 31, 2021</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Ecologic or Community</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge of periodontal health</measure>
    <time_frame>&quot;through study completion, an average of 1 year&quot;</time_frame>
    <description>will be assessed from the 10 questions in the questionnaire and be presented as frequencies and percentages.</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Periodontal health practice</measure>
    <time_frame>&quot;through study completion, an average of 1 year&quot;</time_frame>
    <description>Five questions regarding practice will be analyzed and presented as frequencies and percentages</description>
  </secondary_outcome>
  <secondary_outcome>
    <measure>State of periodontal health</measure>
    <time_frame>&quot;through study completion, an average of 1 year&quot;</time_frame>
    <description>will be determined by measuring the community periodontal index of treatment needs (CPITN) and modified community periodontal index (CPI) that measures the clinical attachment level (CAL) scores, both giving a score of zero to the best periodontal condition and a score of 4 to the worst one</description>
  </secondary_outcome>
  <enrollment type="Actual">511</enrollment>
  <condition>Periodontal Diseases</condition>
  <eligibility>
    <study_pop>
      <textblock>
        - Dental patients will be recruited in a consecutive manner from the outpatient Diagnostic&#xD;
        center, Faculty of Dentistry, Cairo University.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          1. Patients whose age is above 15 years old.&#xD;
&#xD;
          2. Patient consulting in the outpatient clinic&#xD;
&#xD;
          3. Provide informed consent.&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          1. Patients having problem in opening their mouth or undergoing intermaxillary fixation&#xD;
             where oral examination will not be possible.&#xD;
&#xD;
          2. Patients diagnosed with psychiatric problems or intoxicated with alcohol or drugs.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>16 Years</minimum_age>
    <maximum_age>N/A</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Noha A Ghallab, MD</last_name>
    <role>Study Director</role>
    <affiliation>Professor of Oral Medicine and Periodontology, Cairo University</affiliation>
  </overall_official>
  <location>
    <facility>
      <name>Faculty of Oral &amp; Dental Medicine - Cairo University</name>
      <address>
        <city>Cairo</city>
        <country>Egypt</country>
      </address>
    </facility>
  </location>
  <location_countries>
    <country>Egypt</country>
  </location_countries>
  <reference>
    <citation>Murakami S, Mealey BL, Mariotti A, Chapple ILC. Dental plaque-induced gingival conditions. J Periodontol. 2018 Jun;89 Suppl 1:S17-S27. doi: 10.1002/JPER.17-0095.</citation>
    <PMID>29926958</PMID>
  </reference>
  <reference>
    <citation>Gronbeck Linden I, Hagglin C, Gahnberg L, Andersson P. Factors Affecting Older Persons' Ability to Manage Oral Hygiene: A Qualitative Study. JDR Clin Trans Res. 2017 Jul;2(3):223-232. doi: 10.1177/2380084417709267. Epub 2017 May 15.</citation>
    <PMID>30938636</PMID>
  </reference>
  <reference>
    <citation>Holtzman JS, Atchison KA, Macek MD, Markovic D. Oral Health Literacy and Measures of Periodontal Disease. J Periodontol. 2017 Jan;88(1):78-88. doi: 10.1902/jop.2016.160203. Epub 2016 Aug 13.</citation>
    <PMID>27523517</PMID>
  </reference>
  <verification_date>March 2022</verification_date>
  <study_first_submitted>July 16, 2020</study_first_submitted>
  <study_first_submitted_qc>July 16, 2020</study_first_submitted_qc>
  <study_first_posted type="Actual">July 21, 2020</study_first_posted>
  <last_update_submitted>March 10, 2022</last_update_submitted>
  <last_update_submitted_qc>March 10, 2022</last_update_submitted_qc>
  <last_update_posted type="Actual">March 11, 2022</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor-Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Noha Ayman Ghallab</investigator_full_name>
    <investigator_title>Prof. Dr Noha Ayman Ghallab - Professor of Oral Medicine and Periodontology / Cairo University.</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Periodontal Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>No</sharing_ipd>
  </patient_data>
  <!-- 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/NCT04478864
org study id: Esraa2020
nct id: NCT04478864
lead sponsor: 
has dmc: Yes
is fda regulated drug: No
is fda regulated device: No
The main objective of the study is to assess the knowledge and practice of periodontal
      health, which will be done using a well constructed and validated questionnaire. Then
      periodontal health status of all participants will be assessed via clinical examination of
      certain teeth.
The primary outcome of the study is the knowledge of periodontal health.It will be assessed
      by 10 questions focusing on the basic knowledge of gingival appearance, causes and
      consequence of periodontal disease, impact of systemic disease on the progression of
      periodontal conditions, and prevention. Then, periodontal practice will be addressed via
      several questions that evaluate the self-care practices of tooth brushing, flossing, mouth
      rinsing in recent one year, scaling in recent five years, and how to alleviate gingival
      bleeding if there is.

      Periodontal examination using the community periodontal index (CPI) will be done for all of
      the participants to assess the status of periodontal condition. The dentition will be divided
      into sextants and the highest code number corresponding to the worst periodontal condition
      around each of the 10 indexed teeth being recorded.
observational model: Ecologic or Community
time perspective: Cross-Sectional
measure: Knowledge of periodontal health
time frame: "through study completion, an average of 1 year"
description: will be assessed from the 10 questions in the questionnaire and be presented as frequencies and percentages.
measure: Periodontal health practice
time frame: "through study completion, an average of 1 year"
description: Five questions regarding practice will be analyzed and presented as frequencies and percentages
measure: State of periodontal health
time frame: "through study completion, an average of 1 year"
description: will be determined by measuring the community periodontal index of treatment needs (CPITN) and modified community periodontal index (CPI) that measures the clinical attachment level (CAL) scores, both giving a score of zero to the best periodontal condition and a score of 4 to the worst one
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 16 Years
maximum age: N/A
healthy volunteers: Accepts Healthy Volunteers
last name: Noha A Ghallab, MD
role: Study Director
affiliation: Professor of Oral Medicine and Periodontology, Cairo University
facility: 
country: Egypt
citation: Murakami S, Mealey BL, Mariotti A, Chapple ILC. Dental plaque-induced gingival conditions. J Periodontol. 2018 Jun;89 Suppl 1:S17-S27. doi: 10.1002/JPER.17-0095.
PMID: 29926958
citation: Gronbeck Linden I, Hagglin C, Gahnberg L, Andersson P. Factors Affecting Older Persons' Ability to Manage Oral Hygiene: A Qualitative Study. JDR Clin Trans Res. 2017 Jul;2(3):223-232. doi: 10.1177/2380084417709267. Epub 2017 May 15.
PMID: 30938636
citation: Holtzman JS, Atchison KA, Macek MD, Markovic D. Oral Health Literacy and Measures of Periodontal Disease. J Periodontol. 2017 Jan;88(1):78-88. doi: 10.1902/jop.2016.160203. Epub 2016 Aug 13.
PMID: 27523517
responsible party type: Sponsor-Investigator
investigator affiliation: Cairo University
investigator full name: Noha Ayman Ghallab
investigator title: Prof. Dr Noha Ayman Ghallab - Professor of Oral Medicine and Periodontology / Cairo University.
mesh term: Periodontal Diseases
sharing ipd: No