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

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

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.

Study Overview

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

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 Type: Observational
• Enrollment (Actual): 30

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Pregnant women included in study entitled: Periodontal status of type 1 diabetes mellitus and healthy pregnant women: a case-control study from Slovenia

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
GWOB - Gestational week of birth	Week number	Day of delivery
Birth weight	Weight in kg	Day of delivery
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
number of Births with weight ≤ 2500 g	Yes/No	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
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
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
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

Collaborators and Investigators

• Sponsor: University of Ljubljana
• Collaborators: University Medical Centre Ljubljana
• Investigators: Study Director: Rok Schara, DMD, PhD, Assistant Professor

Publications and helpful links

General Publications

• 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.
• 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.
• 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.
• 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.
• 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.
• 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.

Study record dates

Study Major Dates

• Study Start (Actual): May 3, 2012
• Primary Completion (Actual): December 1, 2014
• Study Completion (Actual): December 1, 2014

Study Registration Dates

• First Submitted: May 8, 2023
• First Submitted That Met QC Criteria: August 16, 2023
• First Posted (Actual): August 21, 2023

Study Record Updates

• Last Update Posted (Actual): August 24, 2023
• Last Update Submitted That Met QC Criteria: August 21, 2023
• Last Verified: August 1, 2023

More Information

Terms related to this study

• Keywords: Type 1 Diabetes Mellitus; C-section; Periodontal disease; Gestational Week of Birth
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Stomatognathic Diseases; Mouth Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1; Periodontitis; Periodontal Diseases; Pregnancy Complications; Pregnancy in Diabetics
• Other Study ID Numbers: Pregnancy, DM, Periodontitis

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: All Research data will be available or shared on individual request. Example: conducting Meta-Analysis.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No