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Clinical Trials/NCT02903264
NCT02903264CompletedNot Applicable

Gestational Diabetes Mellitus, Obesity and Periodontal Disease: a Cross Sectional Study

University of Sao Paulo1 site in 1 country67 target enrollmentStarted: January 2007Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
67
Locations
1
Primary Endpoint
Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity

Study Overview

Brief Summary

This study evaluated the periodontal condition of gestational diabetes mellitus (GDM) patients and a healthy non-pregnant control group. For the GDM group all medical data were recorded, including obesity/insulin resistance indicators.

Detailed Description

Gestational diabetes mellitus is associated to a worse periodontal condition. Many patients with these two diseases are also obese. After delivery, some patients maintain the pre-pregnancy obesity status and this condition is also associated to periodontal disease. The mechanisms involved in the relationship of all these medical and periodontal conditions are not clear.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 42 Years (Adult)
Sex
Female
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Inclusion criteria for GDM group was pregnant women with diagnosis of GDM based on glucose determination described in a previous study (19) and under medical treatment of an endocrinologist and the presence of at least one tooth per sextant.
  • Inclusion criteria for control group were absence of periodontal disease, mean age similar to test group and presence of at least one tooth per sextant.

Exclusion Criteria

  • The exclusion criteria for GDM group were pregnant women without diagnosis of diabetes, age below 18 years or higher than 42 years, and the presence of other systemic diseases.
  • In control group, women were excluded if they were pregnant, had diabetes or other systemic disease and age below 18 years or higher than 42 years.

Outcomes

Primary Outcomes

Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity

Time Frame: One day

Severe periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with CAL ≥ 6mm and ≥1 interproximal site with PPD ≥5mm. Moderate periodontitis was defined by the presence of ≥ 2 interproximal sites in different teeth with CAL ≥ 4mm or ≥ 2 interproximal sites in different teeth with PPD ≥5mm. Mild periodontitis was defined as ≥ 2 interproximal sites in different teeth with ≥ 3 mm CAL and ≥ 2 interproximal sites in different teeth with ≥ 4 mm PPD or at least 1 site with PPD ≥ 5 mm (20,21). Gingivitis was determined as follows: Subjects were considered healthy if presented PPD ≤3mm/BOP extent scores \< 10% and with gingivitis if presented PPD ≤3mm/ BOP extent scores \>10%. Prevalence of periodontal disease was the sum of gingivitis, mild, moderate and severe periodontitis.

Obesity measured by a tape and a scale

Time Frame: one day

Obese if: body mass index - BMI ≥ 25 Kg/m2 (weight in kilograms, height in meters) Obese if : waist-to-hip ratio - WHR \>0.85 (cm)

Gestational diabetes mellitus diagnosed by an endocrinologist

Time Frame: one day

Diagnosis stablished by a doctor based on glucose determination. The data was registered in the patient's medical chart.

Secondary Outcomes

  • Dyslipidemia as an indicator of obesity/insulin resistance(one day)
  • Leukocytosis as an indicator of inflammation(one day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Carla Andreotti Damante

Associate professor

University of Sao Paulo

Study Sites (1)

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