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

Diabetes Mellitus, Type 1 Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06002997
• Other study ID #: Pregnancy, DM, Periodontitis
• Status: Completed
• Start date: May 3, 2012
• Est. completion date: December 1, 2014

Study information

• Verified date: August 2023
• Source: University of Ljubljana
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational [Patient Registry]

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 1, 2014
• Est. primary completion date: December 1, 2014
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: N/A to 45 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Pregnancy and/or delivery complications
Analysis of post-delivery reports for pregnancy and/or delivery complications.
• Periodontal disease
Measuring clinical periodontal parameters for assessing presence of periodontal disease.

Locations

Country	Name	City	State
n/a

Sponsors (2)

Lead Sponsor	Collaborator
University of Ljubljana	University Medical Centre Ljubljana

References & Publications (6)

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Number of Delivery and/or Pregnancy complications	Yes/No	Day of delivery
Primary	Number of C-section	Yes/No	Day of delivery
Primary	Number of pregnant women with Pre-eclampsia	Yes/No	Between 28th and 34th week of gestation
Primary	Number of Pre-term births GWOB (Gestational week of birth) = 37th week	Yes/No	Day of delivery
Primary	GWOB - Gestational week of birth	Week number	Day of delivery
Primary	number of Births with weight = 2500 g	Yes/No	Day of delivery
Primary	Birth weight	Weight in kg	Day of delivery
Primary	Number of pregnant women with Periodontal disease	Yes/No	Between 28th and 34th week of gestation
Secondary	Age	Age	Between 28th and 34th week of gestation
Secondary	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
Secondary	PPD (Probing pocket depth)	Probing pocket depth (measured on 6 sites around teeth, unit: mm)	Between 28th and 34th week of gestation
Secondary	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
Secondary	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
Secondary	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
Secondary	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
Secondary	Percantage of HbA1C (Glycosylated haemoglobin)	Glycosylated haemoglobin, Unit: %	Between 28th and 34th week of gestation