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Periodontal DiseasesNCT06002997

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

An observational study of Periodontal Diseases and Periodontitis, run by University of Ljubljana.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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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… Read more about this study

Who is it for?
Ages Up to 45 years, women onlyHealthy volunteers can take part
What is being tested?
Pregnancy and/or delivery complications and Periodontal disease
How many people
30 participants
Where
No sites listed yet
Study dates
3 May 2012to 1 Dec 2014
How long will I take part?
2 Years
Phase
Observational
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages Up to 45 years
  • Women only
  • Healthy volunteers accepted
  • Child, Adult

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

Who may be able to join

  • 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

Who cannot join

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

About this study

Official title: 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.

Read the 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.

Being tested
Pregnancy and/or delivery complications, Periodontal disease
Keywords
Periodontal disease, Type 1 Diabetes Mellitus, C-section, Gestational Week of Birth
Medical subject headings
Periodontal Diseases, Periodontitis, Pregnancy Complications, Pregnancy in Diabetics, Diabetes Mellitus, Type 1

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Pregnancy and/or delivery complicationsOther

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

  • Periodontal diseaseOther

    Measuring clinical periodontal parameters for assessing presence of periodontal disease.

Study groups in NCT06002997
Study groupRoleWhat they receive
Control GroupHealthy pregnant women
Receives: Other: Pregnancy and/or delivery complications; Other: Periodontal disease
Case GroupPregnant women with Diabetes Mellitus Type 1
Receives: Other: Pregnancy and/or delivery complications; Other: Periodontal disease

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Number of Delivery and/or Pregnancy complications

    Yes/No

    Measured: Day of delivery

  2. Number of C-section

    Yes/No

    Measured: Day of delivery

  3. Number of pregnant women with Pre-eclampsia

    Yes/No

    Measured: Between 28th and 34th week of gestation

  4. Number of Pre-term births GWOB (Gestational week of birth) ≤ 37th week

    Yes/No

    Measured: Day of delivery

  5. GWOB - Gestational week of birth

    Week number

    Measured: Day of delivery

  6. number of Births with weight ≤ 2500 g

    Yes/No

    Measured: Day of delivery

  7. Birth weight

    Weight in kg

    Measured: Day of delivery

  8. Number of pregnant women with Periodontal disease

    Yes/No

    Measured: Between 28th and 34th week of gestation

Secondary outcomes (8)

  1. Age

    Age

    Measured: Between 28th and 34th week of gestation

  2. BMI (Body mass index)

    Body mass index - measure of body fat based on height and weight (BMI = Weight (kg) / Height (m)²)

    Measured: Between 28th and 34th week of gestation

  3. PPD (Probing pocket depth)

    Probing pocket depth (measured on 6 sites around teeth, unit: mm)

    Measured: Between 28th and 34th week of gestation

  4. 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.

    Measured: Between 28th and 34th week of gestation

  5. percantage of sites with BOP (Bleeding on probing)

    Bleeding on probing, Yes/No after probing pocket depth measurement 6 sites around each tooth. Unit: %

    Measured: Between 28th and 34th week of gestation

  6. 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.

    Measured: Between 28th and 34th week of gestation

  7. 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.

    Measured: Between 28th and 34th week of gestation

  8. Percantage of HbA1C (Glycosylated haemoglobin)

    Glycosylated haemoglobin, Unit: %

    Measured: Between 28th and 34th week of gestation

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted21 Aug 2023
  2. Study start3 May 2012
  3. Primary completion1 Dec 2014
  4. Study completion1 Dec 2014

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Observational
Observational model
Cohort
Time perspective
Prospective
Enrolment
30 participants (actual)
Target duration
2 Years
IDs, dates and publications
ClinicalTrials.gov ID
NCT06002997
Sponsor's protocol ID
Pregnancy, DM, Periodontitis
Status last verified
Aug 2023
First submitted
8 May 2023
Last updated
24 Aug 2023
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
No: All Research data will be available or shared on individual request. Example: conducting Meta-Analysis.

Publications

  • 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.

    PubMed 17116160

  • 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.

    PubMed 16889630

  • 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.

    PubMed 18496486

  • 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.

    PubMed 12666980

  • 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.

    PubMed 23631578

  • 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.

    PubMed 18295179

Questions about this trial

What is this clinical trial studying?

An observational study of Periodontal Diseases and Periodontitis, run by University of Ljubljana.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 24 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Number of Delivery and/or Pregnancy complications (time frame: Day of delivery). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT06002997, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2023.

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