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NCT Number: NCT06002997

Periodontal Status and Pregnancy or Delivery Complications in Type 1 Diabetes Mellitus 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.

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Key information

Conditions

Periodontal Diseases Autoimmune Diseases Delivery Complication Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Mouth Diseases Nutritional and Metabolic Diseases Periodontitis Pregnancy Complications Pregnancy in Diabetic Pregnancy in Diabetics Stomatognathic Diseases Urogenital Diseases

Age range

Up to 45 year

Sex eligibility

Female

Study type

Observational

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Healthy Pregnant Women
  • Pregnant Women with Diabetes Mellitus type 1
  • Healthy Pregnant Women with signs of Periodontal Disease
  • Pregnant Women with Diabetes Mellitus type 1 and signs of Periodontal disease

Exclusion criteria

  • Smokers
  • Former smokers who had stopped smoking less than five years before participation
  • Pregnant women with other systemic diseases

Treatment and study plan

Pregnancy and/or delivery complications

Other

Analysis of post-delivery reports for pregnancy and/or delivery complications.

Periodontal disease

Other

Measuring clinical periodontal parameters for assessing presence of periodontal disease.

Primary outcomes

  1. Number of Delivery and/or Pregnancy complications

    Time frame: Day of delivery

    Yes/No

  2. Number of C-section

    Time frame: Day of delivery

    Yes/No

  3. Number of pregnant women with Pre-eclampsia

    Time frame: Between 28th and 34th week of gestation

    Yes/No

  4. Number of Pre-term births GWOB (Gestational week of birth) ≤ 37th week

    Time frame: Day of delivery

    Yes/No

  5. GWOB - Gestational week of birth

    Time frame: Day of delivery

    Week number

  6. number of Births with weight ≤ 2500 g

    Time frame: Day of delivery

    Yes/No

  7. Birth weight

    Time frame: Day of delivery

    Weight in kg

  8. Number of pregnant women with Periodontal disease

    Time frame: Between 28th and 34th week of gestation

    Yes/No

Secondary outcomes

  1. Age

    Time frame: Between 28th and 34th week of gestation

    Age

  2. BMI (Body mass index)

    Time frame: Between 28th and 34th week of gestation

    Body mass index - measure of body fat based on height and weight (BMI = Weight (kg) / Height (m)²)

  3. PPD (Probing pocket depth)

    Time frame: Between 28th and 34th week of gestation

    Probing pocket depth (measured on 6 sites around teeth, unit: mm)

  4. CAL (Clinical attachment loss)

    Time frame: Between 28th and 34th week of gestation

    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.

  5. percantage of sites with BOP (Bleeding on probing)

    Time frame: Between 28th and 34th week of gestation

    Bleeding on probing, Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: %

  6. TPIB (Total periodontal inflammatory burden)

    Time frame: Between 28th and 34th week of gestation

    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.

  7. TBPW area (Total bleeding periodontal wound)

    Time frame: Between 28th and 34th week of gestation

    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.

  8. Percantage of HbA1C (Glycosylated haemoglobin)

    Time frame: Between 28th and 34th week of gestation

    Glycosylated haemoglobin, Unit: %

Sponsors and collaborators

Lead sponsor

University of Ljubljana

Other

Collaborators

  • University Medical Centre Ljubljana

Registry information

Official study title

Periodontal Status and Pregnancy or Delivery Complications in Type 1 Diabetes Mellitus Pregnant Women: a Case-control Study From Slovenia

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Aug 21, 2023
Registry last updated
Aug 24, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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