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/NCT06002997</url>
    </required_header>
    <id_info>
      <org_study_id>Pregnancy, DM, Periodontitis</org_study_id>
      <nct_id>NCT06002997</nct_id>
    </id_info>
    <brief_title>Periodontal Status and Pregnancy or Delivery Complications in Type 1 Diabetes Mellitus Pregnant Women</brief_title>
    <official_title>Periodontal Status and Pregnancy or Delivery Complications in Type 1 Diabetes Mellitus Pregnant Women: a Case-control Study From Slovenia</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>University of Ljubljana</agency>
        <agency_class>Other</agency_class>
      </lead_sponsor>
      <collaborator>
        <agency>University Medical Centre Ljubljana</agency>
        <agency_class>Other</agency_class>
      </collaborator>
    </sponsors>
    <source>University of Ljubljana</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>
        The results of contemporary studies suggest an association between inflammatory periodontal&#xD;
        disease and pregnancy and delivery complications. The aim of this study was to assess the&#xD;
        association between periodontal disease, clinical periodontal parameters and pregnancy or&#xD;
        delivery complications in type 1 diabetes mellitus and non-diabetic pregnant women.&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        The results of contemporary studies suggest an association between inflammatory periodontal&#xD;
        disease and pregnancy and delivery complications. The aim of this study was to assess the&#xD;
        association between periodontal disease, clinical periodontal parameters and pregnancy or&#xD;
        delivery complications in type 1 diabetes mellitus and non-diabetic pregnant women. Methods:&#xD;
        15 type 1 diabetes mellitus and 15 non-diabetic primiparous women were enrolled in the&#xD;
        prospective &quot;case-control&quot; study. Investigators compared periodontal status, levels of&#xD;
        glycosylated haemoglobin (HbA1c), high sensitivity C-Reactive Protein (hs-CRP), gestational&#xD;
        week of birth, birth weight of a newborn and pregnancy or delivery complications (C-section,&#xD;
        pre-eclampsia) between the groups.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Completed</overall_status>
    <start_date type="Actual">May 3, 2012</start_date>
    <completion_date type="Actual">December 1, 2014</completion_date>
    <primary_completion_date type="Actual">December 1, 2014</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>2 Years</target_duration>
    <primary_outcome>
      <measure>Number of Delivery and/or Pregnancy complications</measure>
      <time_frame>Day of delivery</time_frame>
      <description>Yes/No</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of C-section</measure>
      <time_frame>Day of delivery</time_frame>
      <description>Yes/No</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of pregnant women with Pre-eclampsia</measure>
      <time_frame>Between 28th and 34th week of gestation</time_frame>
      <description>Yes/No</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of Pre-term births GWOB (Gestational week of birth) ≤ 37th week</measure>
      <time_frame>Day of delivery</time_frame>
      <description>Yes/No</description>
    </primary_outcome>
    <primary_outcome>
      <measure>GWOB - Gestational week of birth</measure>
      <time_frame>Day of delivery</time_frame>
      <description>Week number</description>
    </primary_outcome>
    <primary_outcome>
      <measure>number of Births with weight ≤ 2500 g</measure>
      <time_frame>Day of delivery</time_frame>
      <description>Yes/No</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Birth weight</measure>
      <time_frame>Day of delivery</time_frame>
      <description>Weight in kg</description>
    </primary_outcome>
    <primary_outcome>
      <measure>Number of pregnant women with Periodontal disease</measure>
      <time_frame>Between 28th and 34th week of gestation</time_frame>
      <description>Yes/No</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Age</measure>
      <time_frame>Between 28th and 34th week of gestation</time_frame>
      <description>Age</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>BMI (Body mass index)</measure>
      <time_frame>Between 28th and 34th week of gestation</time_frame>
      <description>Body mass index - measure of body fat based on height and weight (BMI = Weight (kg) / Height (m)²)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>PPD (Probing pocket depth)</measure>
      <time_frame>Between 28th and 34th week of gestation</time_frame>
      <description>Probing pocket depth (measured on 6 sites around teeth, unit: mm)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>CAL (Clinical attachment loss)</measure>
      <time_frame>Between 28th and 34th week of gestation</time_frame>
      <description>Clinical attachment loss (measured on 6 sites around teeth, unit: mm) - This is the measurement of the position of the soft tissue attachment in relation to the cemento-enamel junction (CEJ). Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>percantage of sites with BOP (Bleeding on probing)</measure>
      <time_frame>Between 28th and 34th week of gestation</time_frame>
      <description>Bleeding on probing, Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: %</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TPIB (Total periodontal inflammatory burden)</measure>
      <time_frame>Between 28th and 34th week of gestation</time_frame>
      <description>Total periodontal inflammatory burden - measures of average teeth neck circumferences by tooth type, probing depth (PD) and bleeding on probing (BOP). The subgingival area for each tooth was calculated by multiplying 1/6th of the average cervical circumference of the tooth with each of the six measurements of probing depth. The sum of subgingival areas of all present teeth in a subject represented the total subgingival area of an individual.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>TBPW area (Total bleeding periodontal wound)</measure>
      <time_frame>Between 28th and 34th week of gestation</time_frame>
      <description>Total bleeding periodontal wound - measures of average teeth neck circumferences by tooth type, probing depth (PD) and bleeding on probing (BOP). The subgingival area for each tooth was calculated by multiplying 1/6th of the average cervical circumference of the tooth with each of the six measurements of probing depth. The sum of subgingival bleeding areas of all present teeth in a subject represented the total subgingival area of an individual.</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Percantage of HbA1C (Glycosylated haemoglobin)</measure>
      <time_frame>Between 28th and 34th week of gestation</time_frame>
      <description>Glycosylated haemoglobin, Unit: %</description>
    </secondary_outcome>
    <number_of_groups>2</number_of_groups>
    <enrollment type="Actual">30</enrollment>
    <condition>Periodontal Diseases</condition>
    <condition>Periodontitis</condition>
    <condition>Pregnancy Complications</condition>
    <condition>Pregnancy in Diabetic</condition>
    <condition>Diabetes Mellitus, Type 1</condition>
    <condition>Delivery Complication</condition>
    <arm_group>
      <arm_group_label>Control Group</arm_group_label>
      <description>Healthy pregnant women</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Case Group</arm_group_label>
      <description>Pregnant women with Diabetes Mellitus Type 1</description>
    </arm_group>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Pregnancy and/or delivery complications</intervention_name>
      <description>Analysis of post-delivery reports for pregnancy and/or delivery complications.</description>
      <arm_group_label>Case Group</arm_group_label>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Other</intervention_type>
      <intervention_name>Periodontal disease</intervention_name>
      <description>Measuring clinical periodontal parameters for assessing presence of periodontal disease.</description>
      <arm_group_label>Case Group</arm_group_label>
      <arm_group_label>Control Group</arm_group_label>
    </intervention>
    <eligibility>
      <study_pop>
        <textblock>
          Pregnant women included in study entitled: Periodontal status of type 1 diabetes mellitus&#xD;
          and healthy pregnant women: a case-control study from Slovenia&#xD;
        </textblock>
      </study_pop>
      <sampling_method>Non-Probability Sample</sampling_method>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Healthy Pregnant Women&#xD;
  &#xD;
            -  Pregnant Women with Diabetes Mellitus type 1&#xD;
  &#xD;
            -  Healthy Pregnant Women with signs of Periodontal Disease&#xD;
  &#xD;
            -  Pregnant Women with Diabetes Mellitus type 1 and signs of Periodontal disease&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Smokers&#xD;
  &#xD;
            -  Former smokers who had stopped smoking less than five years before participation&#xD;
  &#xD;
            -  Pregnant women with other systemic diseases&#xD;
        </textblock>
      </criteria>
      <gender>Female</gender>
      <minimum_age>N/A</minimum_age>
      <maximum_age>45 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Rok Schara, DMD, PhD</last_name>
      <role>Study Director</role>
      <affiliation>Assistant Professor</affiliation>
    </overall_official>
    <reference>
      <citation>Bassani DG, Olinto MT, Kreiger N. Periodontal disease and perinatal outcomes: a case-control study. J Clin Periodontol. 2007 Jan;34(1):31-9. doi: 10.1111/j.1600-051X.2006.01012.x. Epub 2006 Nov 20.</citation>
      <PMID>17116160</PMID>
    </reference>
    <reference>
      <citation>Bosnjak A, Relja T, Vucicevic-Boras V, Plasaj H, Plancak D. Pre-term delivery and periodontal disease: a case-control study from Croatia. J Clin Periodontol. 2006 Oct;33(10):710-6. doi: 10.1111/j.1600-051X.2006.00977.x. Epub 2006 Aug 3.</citation>
      <PMID>16889630</PMID>
    </reference>
    <reference>
      <citation>Sacco G, Carmagnola D, Abati S, Luglio PF, Ottolenghi L, Villa A, Maida C, Campus G. Periodontal disease and preterm birth relationship: a review of the literature. Minerva Stomatol. 2008 May;57(5):233-46, 246-50. English, Italian.</citation>
      <PMID>18496486</PMID>
    </reference>
    <reference>
      <citation>Champagne CM, Madianos PN, Lieff S, Murtha AP, Beck JD, Offenbacher S. Periodontal medicine: emerging concepts in pregnancy outcomes. J Int Acad Periodontol. 2000 Jan;2(1):9-13.</citation>
      <PMID>12666980</PMID>
    </reference>
    <reference>
      <citation>Ide M, Papapanou PN. Epidemiology of association between maternal periodontal disease and adverse pregnancy outcomes--systematic review. J Periodontol. 2013 Apr;84(4 Suppl):S181-94. doi: 10.1902/jop.2013.134009.</citation>
      <PMID>23631578</PMID>
    </reference>
    <reference>
      <citation>Ruma M, Boggess K, Moss K, Jared H, Murtha A, Beck J, Offenbacher S. Maternal periodontal disease, systemic inflammation, and risk for preeclampsia. Am J Obstet Gynecol. 2008 Apr;198(4):389.e1-5. doi: 10.1016/j.ajog.2007.12.002. Epub 2008 Mar 4.</citation>
      <PMID>18295179</PMID>
    </reference>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>May 8, 2023</study_first_submitted>
    <study_first_submitted_qc>August 16, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 21, 2023</study_first_posted>
    <last_update_submitted>August 21, 2023</last_update_submitted>
    <last_update_submitted_qc>August 21, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <keyword>Periodontal disease</keyword>
    <keyword>Type 1 Diabetes Mellitus</keyword>
    <keyword>C-section</keyword>
    <keyword>Gestational Week of Birth</keyword>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Periodontitis</mesh_term>
      <mesh_term>Periodontal Diseases</mesh_term>
      <mesh_term>Pregnancy Complications</mesh_term>
      <mesh_term>Pregnancy in Diabetics</mesh_term>
      <mesh_term>Diabetes Mellitus</mesh_term>
      <mesh_term>Diabetes Mellitus, Type 1</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>All Research data will be available or shared on individual request. Example: conducting Meta-Analysis.</ipd_description>
    </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/NCT06002997
  org study id: Pregnancy, DM, Periodontitis
  nct id: NCT06002997
  lead sponsor: 
  collaborator: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  The results of contemporary studies suggest an association between inflammatory periodontal
        disease and pregnancy and delivery complications. The aim of this study was to assess the
        association between periodontal disease, clinical periodontal parameters and pregnancy or
        delivery complications in type 1 diabetes mellitus and non-diabetic pregnant women.
  The results of contemporary studies suggest an association between inflammatory periodontal
        disease and pregnancy and delivery complications. The aim of this study was to assess the
        association between periodontal disease, clinical periodontal parameters and pregnancy or
        delivery complications in type 1 diabetes mellitus and non-diabetic pregnant women. Methods:
        15 type 1 diabetes mellitus and 15 non-diabetic primiparous women were enrolled in the
        prospective "case-control" study. Investigators compared periodontal status, levels of
        glycosylated haemoglobin (HbA1c), high sensitivity C-Reactive Protein (hs-CRP), gestational
        week of birth, birth weight of a newborn and pregnancy or delivery complications (C-section,
        pre-eclampsia) between the groups.
  observational model: Cohort
  time perspective: Prospective
  measure: Number of Delivery and/or Pregnancy complications
  time frame: Day of delivery
  description: Yes/No
  measure: Number of C-section
  time frame: Day of delivery
  description: Yes/No
  measure: Number of pregnant women with Pre-eclampsia
  time frame: Between 28th and 34th week of gestation
  description: Yes/No
  measure: Number of Pre-term births GWOB (Gestational week of birth) ≤ 37th week
  time frame: Day of delivery
  description: Yes/No
  measure: GWOB - Gestational week of birth
  time frame: Day of delivery
  description: Week number
  measure: number of Births with weight ≤ 2500 g
  time frame: Day of delivery
  description: Yes/No
  measure: Birth weight
  time frame: Day of delivery
  description: Weight in kg
  measure: Number of pregnant women with Periodontal disease
  time frame: Between 28th and 34th week of gestation
  description: Yes/No
  measure: Age
  time frame: Between 28th and 34th week of gestation
  description: Age
  measure: BMI (Body mass index)
  time frame: Between 28th and 34th week of gestation
  description: Body mass index - measure of body fat based on height and weight (BMI = Weight (kg) / Height (m)²)
  measure: PPD (Probing pocket depth)
  time frame: Between 28th and 34th week of gestation
  description: Probing pocket depth (measured on 6 sites around teeth, unit: mm)
  measure: CAL (Clinical attachment loss)
  time frame: Between 28th and 34th week of gestation
  description: Clinical attachment loss (measured on 6 sites around teeth, unit: mm) - This is the measurement of the position of the soft tissue attachment in relation to the cemento-enamel junction (CEJ). Two measurements are used to calculate the CAL: the probing depth and the distance from the gingival margin to the CEJ.
  measure: percantage of sites with BOP (Bleeding on probing)
  time frame: Between 28th and 34th week of gestation
  description: Bleeding on probing, Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: %
  measure: TPIB (Total periodontal inflammatory burden)
  time frame: Between 28th and 34th week of gestation
  description: Total periodontal inflammatory burden - measures of average teeth neck circumferences by tooth type, probing depth (PD) and bleeding on probing (BOP). The subgingival area for each tooth was calculated by multiplying 1/6th of the average cervical circumference of the tooth with each of the six measurements of probing depth. The sum of subgingival areas of all present teeth in a subject represented the total subgingival area of an individual.
  measure: TBPW area (Total bleeding periodontal wound)
  time frame: Between 28th and 34th week of gestation
  description: Total bleeding periodontal wound - measures of average teeth neck circumferences by tooth type, probing depth (PD) and bleeding on probing (BOP). The subgingival area for each tooth was calculated by multiplying 1/6th of the average cervical circumference of the tooth with each of the six measurements of probing depth. The sum of subgingival bleeding areas of all present teeth in a subject represented the total subgingival area of an individual.
  measure: Percantage of HbA1C (Glycosylated haemoglobin)
  time frame: Between 28th and 34th week of gestation
  description: Glycosylated haemoglobin, Unit: %
  arm group label: Control Group
  description: Healthy pregnant women
  arm group label: Case Group
  description: Pregnant women with Diabetes Mellitus Type 1
  intervention type: Other
  intervention name: Pregnancy and/or delivery complications
  description: Analysis of post-delivery reports for pregnancy and/or delivery complications.
  arm group label: Case Group
  arm group label: Control Group
  intervention type: Other
  intervention name: Periodontal disease
  description: Measuring clinical periodontal parameters for assessing presence of periodontal disease.
  arm group label: Case Group
  arm group label: Control Group
  study pop: 
  sampling method: Non-Probability Sample
  criteria: 
  gender: Female
  minimum age: N/A
  maximum age: 45 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Rok Schara, DMD, PhD
  role: Study Director
  affiliation: Assistant Professor
  citation: Bassani DG, Olinto MT, Kreiger N. Periodontal disease and perinatal outcomes: a case-control study. J Clin Periodontol. 2007 Jan;34(1):31-9. doi: 10.1111/j.1600-051X.2006.01012.x. Epub 2006 Nov 20.
  PMID: 17116160
  citation: Bosnjak A, Relja T, Vucicevic-Boras V, Plasaj H, Plancak D. Pre-term delivery and periodontal disease: a case-control study from Croatia. J Clin Periodontol. 2006 Oct;33(10):710-6. doi: 10.1111/j.1600-051X.2006.00977.x. Epub 2006 Aug 3.
  PMID: 16889630
  citation: Sacco G, Carmagnola D, Abati S, Luglio PF, Ottolenghi L, Villa A, Maida C, Campus G. Periodontal disease and preterm birth relationship: a review of the literature. Minerva Stomatol. 2008 May;57(5):233-46, 246-50. English, Italian.
  PMID: 18496486
  citation: Champagne CM, Madianos PN, Lieff S, Murtha AP, Beck JD, Offenbacher S. Periodontal medicine: emerging concepts in pregnancy outcomes. J Int Acad Periodontol. 2000 Jan;2(1):9-13.
  PMID: 12666980
  citation: Ide M, Papapanou PN. Epidemiology of association between maternal periodontal disease and adverse pregnancy outcomes--systematic review. J Periodontol. 2013 Apr;84(4 Suppl):S181-94. doi: 10.1902/jop.2013.134009.
  PMID: 23631578
  citation: Ruma M, Boggess K, Moss K, Jared H, Murtha A, Beck J, Offenbacher S. Maternal periodontal disease, systemic inflammation, and risk for preeclampsia. Am J Obstet Gynecol. 2008 Apr;198(4):389.e1-5. doi: 10.1016/j.ajog.2007.12.002. Epub 2008 Mar 4.
  PMID: 18295179
  responsible party type: Sponsor
  mesh term: Periodontitis
  mesh term: Periodontal Diseases
  mesh term: Pregnancy Complications
  mesh term: Pregnancy in Diabetics
  mesh term: Diabetes Mellitus
  mesh term: Diabetes Mellitus, Type 1
  sharing ipd: No
  ipd description: All Research data will be available or shared on individual request. Example: conducting Meta-Analysis.