Clinical trial NCT06002997: Periodontal Status and Pregnancy or Delivery Complications in Type 1 Diabetes Mellitus Pregnant Women
Official title: Periodontal Status and Pregnancy or Delivery Complications in Type 1 Diabetes Mellitus Pregnant Women: a Case-control Study From Slovenia
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Periodontal Diseases
Periodontitis
Pregnancy Complications
Pregnancy in Diabetic
Diabetes Mellitus, Type 1
Delivery Complication
Keywords: Periodontal disease
Type 1 Diabetes Mellitus
C-section
Gestational Week of Birth
Lead sponsor: University of Ljubljana
Sponsor class: OTHER
Collaborators: name: University Medical Centre Ljubljana
First posted: 2023-08-21
Enrollment: 30
Sex: FEMALE
Maximum age (years): 45
Standard ages: CHILD
ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: PROSPECTIVE
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

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.

Eligibility criteria: 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

Primary outcomes:
measure: Number of Delivery and/or Pregnancy complications
timeFrame: Day of delivery
measure: Number of C-section
timeFrame: Day of delivery
measure: Number of pregnant women with Pre-eclampsia
timeFrame: Between 28th and 34th week of gestation
measure: Number of Pre-term births GWOB (Gestational week of birth) ≤ 37th week
timeFrame: Day of delivery
measure: GWOB - Gestational week of birth
timeFrame: Day of delivery
measure: number of Births with weight ≤ 2500 g
timeFrame: Day of delivery
measure: Birth weight
timeFrame: Day of delivery
measure: Number of pregnant women with Periodontal disease
timeFrame: Between 28th and 34th week of gestation
Secondary outcomes:
measure: Age
timeFrame: Between 28th and 34th week of gestation
measure: BMI (Body mass index)
timeFrame: Between 28th and 34th week of gestation
measure: PPD (Probing pocket depth)
timeFrame: Between 28th and 34th week of gestation
measure: CAL (Clinical attachment loss)
timeFrame: Between 28th and 34th week of gestation
measure: percantage of sites with BOP (Bleeding on probing)
timeFrame: Between 28th and 34th week of gestation
measure: TPIB (Total periodontal inflammatory burden)
timeFrame: Between 28th and 34th week of gestation
measure: TBPW area (Total bleeding periodontal wound)
timeFrame: Between 28th and 34th week of gestation
measure: Percantage of HbA1C (Glycosylated haemoglobin)
timeFrame: Between 28th and 34th week of gestation
Other outcomes:
Locations:
Study officials:
affiliation: Assistant Professor
name: Rok Schara, DMD, PhD
role: STUDY_DIRECTOR
References:
citation: 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.
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.
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.
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.
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.
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.