<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/NCT01675180</url>
  </required_header>
  <id_info>
    <org_study_id>2012/633/REK nord</org_study_id>
    <nct_id>NCT01675180</nct_id>
  </id_info>
  <brief_title>Self Reported Oral Health, Awareness and Attitude Towards Dental Care Among Pregnant Women</brief_title>
  <official_title>Self Reported Oral Health, Awareness and Attitude Towards Dental Care and Risk of Dental Caries Among Pregnant Women in Norway</official_title>
  <sponsors>
    <lead_sponsor>
      <agency>University of Tromso</agency>
      <agency_class>Other</agency_class>
    </lead_sponsor>
    <collaborator>
      <agency>University Hospital of North Norway</agency>
      <agency_class>Other</agency_class>
    </collaborator>
  </sponsors>
  <source>University of Tromso</source>
  <oversight_info>
    <has_dmc>No</has_dmc>
  </oversight_info>
  <brief_summary>
    <textblock>
      Purpose/Objective of the study:&#xD;
&#xD;
      The main objective of the study is to investigate oral health awareness and attitudes towards&#xD;
      oral health among Norwegian pregnant women and assess the impact of information about oral&#xD;
      hygiene on the risk of dental caries during pregnancy.&#xD;
&#xD;
      The hypothesis of the study are:&#xD;
&#xD;
        1. The state of oral health during pregnancy depends on pregnant woman's preventive oral&#xD;
           hygiene behaviour and practice.&#xD;
&#xD;
        2. Pregnant women with high level of oral health awareness and positive attitude towards&#xD;
           oral health are more likely to visit their dentists regularly and have better oral&#xD;
           hygiene compared to those with less awareness.&#xD;
&#xD;
        3. Proper information and guidance on oral hygiene care provided during pregnancy can help&#xD;
           to improve oral bacteriological milieu and reduce the dental caries risk among pregnant&#xD;
           women.&#xD;
    </textblock>
  </brief_summary>
  <overall_status>Unknown status</overall_status>
  <last_known_status>Recruiting</last_known_status>
  <start_date>February 2013</start_date>
  <completion_date type="Anticipated">October 2019</completion_date>
  <primary_completion_date type="Anticipated">December 2018</primary_completion_date>
  <phase>N/A</phase>
  <study_type>Interventional</study_type>
  <has_expanded_access>No</has_expanded_access>
  <study_design_info>
    <allocation>Randomized</allocation>
    <intervention_model>Parallel Assignment</intervention_model>
    <primary_purpose>Other</primary_purpose>
    <masking>Double (Participant, Care Provider)</masking>
  </study_design_info>
  <primary_outcome>
    <measure>Oral health</measure>
    <time_frame>In 4 weeks interval after recrutiatment of study participants</time_frame>
    <description>Streptococcus Mutans, lactobacilli</description>
  </primary_outcome>
  <secondary_outcome>
    <measure>Attitude</measure>
    <time_frame>After approximately 6 months</time_frame>
    <description>Attitude towards oral health care</description>
  </secondary_outcome>
  <number_of_arms>2</number_of_arms>
  <enrollment type="Anticipated">200</enrollment>
  <condition>Pregnancy</condition>
  <condition>Oral Health</condition>
  <condition>Attitude</condition>
  <condition>Oxidative Stress</condition>
  <arm_group>
    <arm_group_label>Information</arm_group_label>
    <arm_group_type>Other</arm_group_type>
    <description>Women randomized to the intervention will recieve information and counseling on oral health care during pregnancy</description>
  </arm_group>
  <arm_group>
    <arm_group_label>Control</arm_group_label>
    <arm_group_type>No Intervention</arm_group_type>
  </arm_group>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Information</intervention_name>
    <description>Women in the intervention group will recieve information and counseling on oral health care during pregnancy</description>
    <arm_group_label>Information</arm_group_label>
  </intervention>
  <intervention>
    <intervention_type>Other</intervention_type>
    <intervention_name>Control</intervention_name>
    <description>No intervention</description>
    <arm_group_label>Information</arm_group_label>
  </intervention>
  <eligibility>
    <criteria>
      <textblock>
        Inclusion Criteria:&#xD;
&#xD;
          -  Women with viable pregnancy ≥ 17 weeks gestation&#xD;
&#xD;
        Exclusion Criteria:&#xD;
&#xD;
          -  Those not willing to participate in the study.&#xD;
&#xD;
          -  Women who are unable to communicate well in Norwegian.&#xD;
&#xD;
          -  Women who have been diagnosed to have a fetus with a chromosomal or structural fetal&#xD;
             anomaly and do not plan to continue their pregnancy&#xD;
      </textblock>
    </criteria>
    <gender>Female</gender>
    <minimum_age>18 Years</minimum_age>
    <maximum_age>50 Years</maximum_age>
    <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
  </eligibility>
  <overall_official>
    <last_name>Ganesh Acharya, Professor</last_name>
    <role>Principal Investigator</role>
    <affiliation>University of Tromsø and University Hospital of North Norway</affiliation>
  </overall_official>
  <overall_contact>
    <last_name>Ganesh Acharya, Professor</last_name>
    <phone>77626432</phone>
    <email>ganesh.acharya@uit.no</email>
  </overall_contact>
  <location>
    <facility>
      <name>Department of Obstetrics and Gynaecology, University Hospital of Northern Norway (UNN)</name>
      <address>
        <city>Tromsø</city>
        <state>Troms</state>
        <zip>9037</zip>
        <country>Norway</country>
      </address>
    </facility>
    <status>Recruiting</status>
    <contact>
      <last_name>Ganesh Acharya, Professor</last_name>
      <phone>+47 77 62 6432</phone>
      <email>ganesh.acharya@uit.no</email>
    </contact>
  </location>
  <location_countries>
    <country>Norway</country>
  </location_countries>
  <verification_date>February 2017</verification_date>
  <study_first_submitted>August 27, 2012</study_first_submitted>
  <study_first_submitted_qc>August 27, 2012</study_first_submitted_qc>
  <study_first_posted type="Estimate">August 29, 2012</study_first_posted>
  <last_update_submitted>February 9, 2018</last_update_submitted>
  <last_update_submitted_qc>February 9, 2018</last_update_submitted_qc>
  <last_update_posted type="Actual">February 12, 2018</last_update_posted>
  <responsible_party>
    <responsible_party_type>Sponsor</responsible_party_type>
  </responsible_party>
  <keyword>pregnancy, oral health, attitude, awareness, streptococcus mutans, lactobacilli, oxidative stress</keyword>
  <!-- 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/NCT01675180
org study id: 2012/633/REK nord
nct id: NCT01675180
lead sponsor: 
collaborator: 
has dmc: No
Purpose/Objective of the study:

      The main objective of the study is to investigate oral health awareness and attitudes towards
      oral health among Norwegian pregnant women and assess the impact of information about oral
      hygiene on the risk of dental caries during pregnancy.

      The hypothesis of the study are:

        1. The state of oral health during pregnancy depends on pregnant woman's preventive oral
           hygiene behaviour and practice.

        2. Pregnant women with high level of oral health awareness and positive attitude towards
           oral health are more likely to visit their dentists regularly and have better oral
           hygiene compared to those with less awareness.

        3. Proper information and guidance on oral hygiene care provided during pregnancy can help
           to improve oral bacteriological milieu and reduce the dental caries risk among pregnant
           women.
allocation: Randomized
intervention model: Parallel Assignment
primary purpose: Other
masking: Double (Participant, Care Provider)
measure: Oral health
time frame: In 4 weeks interval after recrutiatment of study participants
description: Streptococcus Mutans, lactobacilli
measure: Attitude
time frame: After approximately 6 months
description: Attitude towards oral health care
arm group label: Information
arm group type: Other
description: Women randomized to the intervention will recieve information and counseling on oral health care during pregnancy
arm group label: Control
arm group type: No Intervention
intervention type: Other
intervention name: Information
description: Women in the intervention group will recieve information and counseling on oral health care during pregnancy
arm group label: Information
intervention type: Other
intervention name: Control
description: No intervention
arm group label: Information
criteria: 
gender: Female
minimum age: 18 Years
maximum age: 50 Years
healthy volunteers: Accepts Healthy Volunteers
last name: Ganesh Acharya, Professor
role: Principal Investigator
affiliation: University of Tromsø and University Hospital of North Norway
last name: Ganesh Acharya, Professor
phone: 77626432
email: ganesh.acharya@uit.no
facility: 
status: Recruiting
contact: 
country: Norway
responsible party type: Sponsor