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

NCT06002997 | Completed

• 1 other identifier: Pregnancy, DM, Periodontitis
• Study Type: observational
• Target: 30
• Locations: 0 countries
• Sites: N/A

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.

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

Outcome Measures

Primary Outcomes (8)

• 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

• GWOB - Gestational week of birth

  Week number

  Day of delivery

• number of Births with weight ≤ 2500 g

  Yes/No

  Day of delivery

• Birth weight

  Weight in kg

  Day of delivery

• Number of pregnant women with Periodontal disease

  Yes/No

  Between 28th and 34th week of gestation

Secondary Outcomes (8)

• Age

  Between 28th and 34th week of gestation

• BMI (Body mass index)

  Between 28th and 34th week of gestation

• PPD (Probing pocket depth)

  Between 28th and 34th week of gestation

• CAL (Clinical attachment loss)

  Between 28th and 34th week of gestation

• percantage of sites with BOP (Bleeding on probing)

  Between 28th and 34th week of gestation

Study Arms (2)

Control Group

Healthy pregnant women

Other: Pregnancy and/or delivery complications; Other: Periodontal disease

Case Group

Pregnant women with Diabetes Mellitus Type 1

Other: Pregnancy and/or delivery complications; Other: Periodontal disease

Interventions

Pregnancy and/or delivery complications OTHER

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

Case Group; Control Group

Periodontal disease OTHER

Measuring clinical periodontal parameters for assessing presence of periodontal disease.

Case Group; Control Group

Eligibility Criteria

• Age: Up to 45 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64)
• 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

You may qualify if:

• 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

You may not qualify if:

• Smokers
• Former smokers who had stopped smoking less than five years before participation
• Pregnant women with other systemic diseases

Sponsors & Collaborators

• University of Ljubljana: lead
• University Medical Centre Ljubljana: collaborator

Related 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.

  PMID: 17116160 BACKGROUND

• 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.

  PMID: 16889630 BACKGROUND

• 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.

  PMID: 18496486 BACKGROUND

• 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.

  PMID: 12666980 BACKGROUND

• 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.

  PMID: 23631578 BACKGROUND

• 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.

  PMID: 18295179 BACKGROUND

MeSH Terms

Conditions

Periodontal Diseases; Periodontitis; Pregnancy Complications; Pregnancy in Diabetics; Diabetes Mellitus, Type 1

Condition Hierarchy (Ancestors)

Mouth Diseases; Stomatognathic Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases

Study Officials

• Rok Schara, DMD, PhD

  Assistant Professor

  STUDY DIRECTOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Target Duration: 2 Years
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 8, 2023
• First Posted: August 21, 2023
• Study Start: May 3, 2012
• Primary Completion: December 1, 2014
• Study Completion: December 1, 2014
• Last Updated: August 24, 2023

Record last verified: 2023-08

Data Sharing

• IPD Sharing: Will not share