Delivery Complication, Diabetes Mellitus, Type 1, Periodontal Diseases, Periodontitis, Pregnancy Complications, Pregnancy in Diabetic
Conditions
Keywords
Periodontal disease, Type 1 Diabetes Mellitus, C-section, Gestational Week of Birth
Brief summary
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
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.
Interventions
OTHERPregnancy and/or delivery complications
Analysis of post-delivery reports for pregnancy and/or delivery complications.
OTHERPeriodontal disease
Measuring clinical periodontal parameters for assessing presence of periodontal disease.
Sponsors
University Medical Centre Ljubljana
University of Ljubljana
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
FEMALE
Age
No minimum to 45 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Number of pregnant women with Periodontal disease | Between 28th and 34th week of gestation | Yes/No |
| Number of Delivery and/or Pregnancy complications | Day of delivery | Yes/No |
| Number of C-section | Day of delivery | Yes/No |
| Number of pregnant women with Pre-eclampsia | Between 28th and 34th week of gestation | Yes/No |
| Number of Pre-term births GWOB (Gestational week of birth) ≤ 37th week | Day of delivery | Yes/No |
| GWOB - Gestational week of birth | Day of delivery | Week number |
| number of Births with weight ≤ 2500 g | Day of delivery | Yes/No |
| Birth weight | Day of delivery | Weight in kg |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Age | Between 28th and 34th week of gestation | Age |
| BMI (Body mass index) | 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) |
| PPD (Probing pocket depth) | Between 28th and 34th week of gestation | Probing pocket depth (measured on 6 sites around teeth, unit: mm) |
| CAL (Clinical attachment loss) | 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. |
| percantage of sites with BOP (Bleeding on probing) | Between 28th and 34th week of gestation | Bleeding on probing, Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: % |
| TPIB (Total periodontal inflammatory burden) | 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. |
| TBPW area (Total bleeding periodontal wound) | 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. |
| Percantage of HbA1C (Glycosylated haemoglobin) | Between 28th and 34th week of gestation | Glycosylated haemoglobin, Unit: % |
Outcome results
None listed