<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/NCT03780114</url>
  </required_header>
  <id_info>
    <org_study_id>CEBD-CU-2018-11-17</org_study_id>
    <nct_id>NCT03780114</nct_id>
  </id_info>
  <brief_title>Knowledge, Attitude and Practice Survey for Egyptian Dentists About Infection Control in Pediatric Dental Clinics</brief_title>
  <acronym>case-only</acronym>
  <official_title>Knowledge, Attitude and Practice Survey for Group of Egyptian Dentists About Infection Control in Different Pediatric Dental Clinics: A Cross-Sectional Study</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>Cairo University</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
  </sponsors>
  <source>Cairo 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>
      This study is designed to gather information about knowledge of pediatric dentistry interns&#xD;
      towards infection control procedures in pediatric dental clinics, also about their attitude&#xD;
      towards the rules and guidelines of infection control, and finally their practice to these&#xD;
      guidelines to achieve the ultimate infection control in pediatric dental clinics.&#xD;
    </textblock>
  </brief_summary>
  <detailed_description>
    <textblock>
      Patient's safety is considered a very important medical protocol which aims at improving&#xD;
      quality of patient's care, minimizing treatment mistakes and improving safety to the maximum&#xD;
      extent that can be reached. On this approach infection is one of the most critical issues in&#xD;
      healthcare service worldwide, where it can be transmitted during dental procedures through&#xD;
      direct and indirect contact , in addition to high risk blood borne infections , and nowadays&#xD;
      we are facing global emergence and re-emergence of many communicable diseases that can also&#xD;
      be transmitted during dental practice.&#xD;
&#xD;
      As a result of the high risk of transmission of the above infections, high standard&#xD;
      precautions must be implemented for all patients attending dental clinics regardless of their&#xD;
      infection status , because those patients could be in the prodromal phase or carriers without&#xD;
      even knowing. In addition, some infectious diseases have prolonged incubation periods during&#xD;
      which antibodies can't be detected , So in order to avoid infection transmission hazards and&#xD;
      to achieve patient's safety, infection prevention and control of cross-contamination are our&#xD;
      goal in providing a secure environment for patients and healthcare workers within healthcare&#xD;
      settings in general and more specifically in dental practices.&#xD;
&#xD;
      Transmission of infectious agents among patients and dental health care personnel (DHCP) in&#xD;
      dental settings is rare. However, transmissions in dental settings, including&#xD;
      patient-to-patient transmissions, have been documented. In most cases, investigators failed&#xD;
      to link a specific lapse of infection prevention and control with a particular transmission.&#xD;
      However, reported breakdowns in basic infection prevention procedures included unsafe&#xD;
      injection practices, failure to heat sterilize dental handpieces between patients, and&#xD;
      failure to monitor autoclaves by conducting spore tests.&#xD;
&#xD;
      Generally, Concerns have increased considerably by a report about the transmission of human&#xD;
      immunodeficiency virus (HIV) from an American dentist to five of his patients. With the&#xD;
      presence of people infected with hepatitis B and C and the HIV viruses, cross infection has&#xD;
      become a major concern for dentists, dental personnel and patients. On the other hand,&#xD;
      developing countries including Egypt showed the increased prevalence of transmission of&#xD;
      infection among dental clinics.&#xD;
&#xD;
      Therefore, Universal precautions should be followed considering all patients as infectious.&#xD;
      However, Most hospitals have no infection control programs due to the lack of awareness of&#xD;
      the problem or absence of properly trained personnel. This highlight the need for training to&#xD;
      improve understanding of principles, practices, and implementation, in addition to the&#xD;
      conditions that cause disease transmission, So all dental settings, regardless of the level&#xD;
      of care provided, must make infection prevention a priority and should be equipped to observe&#xD;
      Standard Precautions and other infection prevention recommendations contained in CDC's&#xD;
      Guidelines for Infection Control in Dental Health-Care Settings - 2003.&#xD;
&#xD;
      POS format:&#xD;
&#xD;
      P (population): Interns in pediatric dental clinics.&#xD;
&#xD;
      O (outcome): Knowledge, attitude, and practice of infection control in pediatric dental&#xD;
      clinics.&#xD;
&#xD;
        -  Outcome measuring tool: A Questionnaire.&#xD;
&#xD;
        -  Outcome measuring unit: Closed- ended questions (dichotomous, multiple choice questions,&#xD;
           Likert, and matrix questions).&#xD;
&#xD;
      S (study design): Cross-sectional survey (Observational type of study).&#xD;
&#xD;
      Research question:&#xD;
&#xD;
      What is the level of knowledge, attitude, and practice of intern pediatric dentists in&#xD;
      pediatric dental clinics in Faculty of Dentistry, Cairo University towards infection control&#xD;
      protocols and guidelines in pediatric dentistry?&#xD;
    </textblock>
  </detailed_description>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Not yet recruiting</last_known_status>
  <start_date type="Anticipated">February 1, 2019</start_date>
  <completion_date type="Anticipated">June 1, 2019</completion_date>
  <primary_completion_date type="Anticipated">March 1, 2019</primary_completion_date>
  <study_type>Observational</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <observational_model>Case-Only</observational_model>
    <time_perspective>Cross-Sectional</time_perspective>
  </study_design_info>
  <primary_outcome>
    <measure>Knowledge</measure>
    <time_frame>1 month</time_frame>
    <description>closed- ended questionnaire , 16 knowledge questions, if the total number of participants answered all the questions this will be mentioned, and if any was not answered or missed for any reason this will be reported.</description>
  </primary_outcome>
  <other_outcome>
    <measure>Attitude</measure>
    <time_frame>1 month</time_frame>
    <description>closed- ended questionnaire, 8 questions, if the total number of participants answered all the questions this will be mentioned, and if any was not answered or missed for any reason this will be reported.</description>
  </other_outcome>
  <other_outcome>
    <measure>Practice</measure>
    <time_frame>1 month</time_frame>
    <description>closed- ended questionnaire, 36 questions, if the total number of participants answered all the questions this will be mentioned, and if any was not answered or missed for any reason this will be reported.</description>
  </other_outcome>
  <number_of_groups>1</number_of_groups>
  <enrollment type="Anticipated">100</enrollment>
  <condition>Infection Control</condition>
  <arm_group>
    <arm_group_label>interns</arm_group_label>
    <description>intern pediatric dentists</description>
  </arm_group>
  <eligibility>
    <study_pop>
      <textblock>
        • Interns who have ended their pediatric dentistry rounds will be asked to answer the&#xD;
        questionnaire.&#xD;
      </textblock>
    </study_pop>
    <sampling_method>Probability Sample</sampling_method>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Interns working in pediatric dental clinics who have ended their rounds in faculty of&#xD;
             Dentistry, Cairo University&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  interns and dentists who refuse to participate in the study.&#xD;
&#xD;
          -  interns who are not performing regular attendance in the pediatric dental clinics.&#xD;
      </textblock>
    </criteria>
    <gender>All</gender>
    <minimum_age>23 Years</minimum_age>
    <maximum_age>35 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <verification_date>December 2018</verification_date>
  <study_first_submitted>December 7, 2018</study_first_submitted>
  <study_first_submitted_qc>December 15, 2018</study_first_submitted_qc>
  <study_first_posted type="Actual">December 19, 2018</study_first_posted>
  <last_update_submitted>December 15, 2018</last_update_submitted>
  <last_update_submitted_qc>December 15, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">December 19, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Principal Investigator</responsible_party_type>
    <investigator_affiliation>Cairo University</investigator_affiliation>
    <investigator_full_name>Noha Hany Hassan Khalil Hassan</investigator_full_name>
    <investigator_title>Principal investigator</investigator_title>
  </responsible_party>
  <condition_browse>
    <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
    <mesh_term>Infections</mesh_term>
    <mesh_term>Communicable Diseases</mesh_term>
  </condition_browse>
  <patient_data>
    <sharing_ipd>Undecided</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/NCT03780114
org study id: CEBD-CU-2018-11-17
nct id: NCT03780114
lead sponsor: 
has dmc: No
is fda regulated drug: No
is fda regulated device: No
This study is designed to gather information about knowledge of pediatric dentistry interns
      towards infection control procedures in pediatric dental clinics, also about their attitude
      towards the rules and guidelines of infection control, and finally their practice to these
      guidelines to achieve the ultimate infection control in pediatric dental clinics.
Patient's safety is considered a very important medical protocol which aims at improving
      quality of patient's care, minimizing treatment mistakes and improving safety to the maximum
      extent that can be reached. On this approach infection is one of the most critical issues in
      healthcare service worldwide, where it can be transmitted during dental procedures through
      direct and indirect contact , in addition to high risk blood borne infections , and nowadays
      we are facing global emergence and re-emergence of many communicable diseases that can also
      be transmitted during dental practice.

      As a result of the high risk of transmission of the above infections, high standard
      precautions must be implemented for all patients attending dental clinics regardless of their
      infection status , because those patients could be in the prodromal phase or carriers without
      even knowing. In addition, some infectious diseases have prolonged incubation periods during
      which antibodies can't be detected , So in order to avoid infection transmission hazards and
      to achieve patient's safety, infection prevention and control of cross-contamination are our
      goal in providing a secure environment for patients and healthcare workers within healthcare
      settings in general and more specifically in dental practices.

      Transmission of infectious agents among patients and dental health care personnel (DHCP) in
      dental settings is rare. However, transmissions in dental settings, including
      patient-to-patient transmissions, have been documented. In most cases, investigators failed
      to link a specific lapse of infection prevention and control with a particular transmission.
      However, reported breakdowns in basic infection prevention procedures included unsafe
      injection practices, failure to heat sterilize dental handpieces between patients, and
      failure to monitor autoclaves by conducting spore tests.

      Generally, Concerns have increased considerably by a report about the transmission of human
      immunodeficiency virus (HIV) from an American dentist to five of his patients. With the
      presence of people infected with hepatitis B and C and the HIV viruses, cross infection has
      become a major concern for dentists, dental personnel and patients. On the other hand,
      developing countries including Egypt showed the increased prevalence of transmission of
      infection among dental clinics.

      Therefore, Universal precautions should be followed considering all patients as infectious.
      However, Most hospitals have no infection control programs due to the lack of awareness of
      the problem or absence of properly trained personnel. This highlight the need for training to
      improve understanding of principles, practices, and implementation, in addition to the
      conditions that cause disease transmission, So all dental settings, regardless of the level
      of care provided, must make infection prevention a priority and should be equipped to observe
      Standard Precautions and other infection prevention recommendations contained in CDC's
      Guidelines for Infection Control in Dental Health-Care Settings - 2003.

      POS format:

      P (population): Interns in pediatric dental clinics.

      O (outcome): Knowledge, attitude, and practice of infection control in pediatric dental
      clinics.

        -  Outcome measuring tool: A Questionnaire.

        -  Outcome measuring unit: Closed- ended questions (dichotomous, multiple choice questions,
           Likert, and matrix questions).

      S (study design): Cross-sectional survey (Observational type of study).

      Research question:

      What is the level of knowledge, attitude, and practice of intern pediatric dentists in
      pediatric dental clinics in Faculty of Dentistry, Cairo University towards infection control
      protocols and guidelines in pediatric dentistry?
observational model: Case-Only
time perspective: Cross-Sectional
measure: Knowledge
time frame: 1 month
description: closed- ended questionnaire , 16 knowledge questions, if the total number of participants answered all the questions this will be mentioned, and if any was not answered or missed for any reason this will be reported.
measure: Attitude
time frame: 1 month
description: closed- ended questionnaire, 8 questions, if the total number of participants answered all the questions this will be mentioned, and if any was not answered or missed for any reason this will be reported.
measure: Practice
time frame: 1 month
description: closed- ended questionnaire, 36 questions, if the total number of participants answered all the questions this will be mentioned, and if any was not answered or missed for any reason this will be reported.
arm group label: interns
description: intern pediatric dentists
study pop: 
sampling method: Probability Sample
criteria: 
gender: All
minimum age: 23 Years
maximum age: 35 Years
healthy volunteers: Accepts Healthy Volunteers
responsible party type: Principal Investigator
investigator affiliation: Cairo University
investigator full name: Noha Hany Hassan Khalil Hassan
investigator title: Principal investigator
mesh term: Infections
mesh term: Communicable Diseases
sharing ipd: Undecided