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

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

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

Conditions
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Periodontal Diseases, Periodontitis, Pregnancy Complications, Pregnancy in Diabetic, Diabetes Mellitus, Type 1, Delivery Complication

Intervention / Treatment
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* Other: Pregnancy and/or delivery complications
* Other: Periodontal disease


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Maximum Age: 45 Years

Sexes Eligible for Study
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Female

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Control Group<br>Healthy pregnant women | Other: Pregnancy and/or delivery complications<br>* Analysis of post-delivery reports for pregnancy and/or delivery complications.<br>Other: Periodontal disease<br>* Measuring clinical periodontal parameters for assessing presence of periodontal disease.<br>|
| Case Group<br>Pregnant women with Diabetes Mellitus Type 1 | Other: Pregnancy and/or delivery complications<br>* Analysis of post-delivery reports for pregnancy and/or delivery complications.<br>Other: Periodontal disease<br>* Measuring clinical periodontal parameters for assessing presence of periodontal disease.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of Delivery and/or Pregnancy complications | Yes/No | Day of delivery | 
| Number of C-section | Yes/No | Day of delivery | 
| Number of pregnant women with Pre-eclampsia | Yes/No | Between 28th and 34th week of gestation | 
| Number of Pre-term births GWOB (Gestational week of birth) ≤ 37th week | Yes/No | Day of delivery | 
| GWOB - Gestational week of birth | Week number | Day of delivery | 
| number of Births with weight ≤ 2500 g | Yes/No | Day of delivery | 
| Birth weight | Weight in kg | Day of delivery | 
| Number of pregnant women with Periodontal disease | Yes/No | Between 28th and 34th week of gestation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Age | Age | Between 28th and 34th week of gestation | 
| BMI (Body mass index) | Body mass index - measure of body fat based on height and weight (BMI = Weight (kg) / Height (m)²) | Between 28th and 34th week of gestation | 
| PPD (Probing pocket depth) | Probing pocket depth (measured on 6 sites around teeth, unit: mm) | Between 28th and 34th week of gestation | 
| CAL (Clinical attachment loss) | 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. | Between 28th and 34th week of gestation | 
| percantage of sites with BOP (Bleeding on probing) | Bleeding on probing, Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % | Between 28th and 34th week of gestation | 
| TPIB (Total periodontal inflammatory burden) | 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. | Between 28th and 34th week of gestation | 
| TBPW area (Total bleeding periodontal wound) | 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. | Between 28th and 34th week of gestation | 
| Percantage of HbA1C (Glycosylated haemoglobin) | Glycosylated haemoglobin, Unit: % | Between 28th and 34th week of gestation | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Periodontal disease, Type 1 Diabetes Mellitus, C-section, Gestational Week of Birth