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

Completed

• Conditions: Periodontal Diseases; Delivery Complication; Diabetes Mellitus, Type 1; Periodontitis; Pregnancy Complications; Pregnancy in Diabetic
• Interventions: Other: Pregnancy and/or delivery complications; Other: Periodontal disease

• Registration Number: NCT06002997
• Lead Sponsor: University of Ljubljana

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.

Study Timeline

• Study Start: 2012-05-03
• Primary Completion: 2014-12-01
• Study Completion: 2014-12-01
• Study First Submitted: 2023-05-08
• Status Verified: 2023-08
• Study First Submitted QC: 2023-08-16
• Study First Posted: 2023-08-21
• Last Update Submitted: 2023-08-21
• Last Update Posted: 2023-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 30

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Case Group	Pregnancy and/or delivery complications	Pregnant women with Diabetes Mellitus Type 1
Control Group	Pregnancy and/or delivery complications	Healthy pregnant women
Case Group	Periodontal disease	Pregnant women with Diabetes Mellitus Type 1
Control Group	Periodontal disease	Healthy pregnant women

Primary Outcome Measures

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

Secondary Outcome Measures

Name	Time	Method
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 HbA1C (Glycosylated haemoglobin)	Between 28th and 34th week of gestation	Glycosylated haemoglobin, Unit: %
PPD (Probing pocket depth)	Between 28th and 34th week of gestation	Probing pocket depth (measured on 6 sites around teeth, unit: mm)
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.
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)
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.