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

NCT ID: NCT06002997

Last Updated: 2023-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2012-05-03

Study Completion Date

2014-12-01

Brief Summary

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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

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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.

Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Control Group

Healthy pregnant women

Pregnancy and/or delivery complications

Intervention Type OTHER

Analysis of post-delivery reports for pregnancy and/or delivery complications.

Periodontal disease

Intervention Type OTHER

Measuring clinical periodontal parameters for assessing presence of periodontal disease.

Case Group

Pregnant women with Diabetes Mellitus Type 1

Pregnancy and/or delivery complications

Intervention Type OTHER

Analysis of post-delivery reports for pregnancy and/or delivery complications.

Periodontal disease

Intervention Type OTHER

Measuring clinical periodontal parameters for assessing presence of periodontal disease.

Interventions

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Pregnancy and/or delivery complications

Analysis of post-delivery reports for pregnancy and/or delivery complications.

Intervention Type OTHER

Periodontal disease

Measuring clinical periodontal parameters for assessing presence of periodontal disease.

Intervention Type OTHER

Eligibility Criteria

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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
Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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University Medical Centre Ljubljana

OTHER

Sponsor Role collaborator

University of Ljubljana

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Rok Schara, DMD, PhD

Role: STUDY_DIRECTOR

Assistant Professor

References

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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.

Reference Type BACKGROUND
PMID: 17116160 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 16889630 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18496486 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 12666980 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 23631578 (View on PubMed)

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.

Reference Type BACKGROUND
PMID: 18295179 (View on PubMed)

Other Identifiers

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Pregnancy, DM, Periodontitis

Identifier Type: -

Identifier Source: org_study_id

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