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NCT Number: NCT02903264

Gestational Diabetes Mellitus, Obesity and Periodontal Disease

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.

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Key information

Conditions

Diabetes Mellitus, Gestational Body Weight Diabetes Mellitus Diabetes, Gestational Endocrine System Diseases Female Urogenital Diseases and Pregnancy Complications Glucose Metabolism Disorders Metabolic Diseases Mouth Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Periodontal Diseases Pregnancy Complications Signs and Symptoms Stomatognathic Diseases Urogenital Diseases

Age range

18 year–42 year

Sex eligibility

Female

Study type

Observational

Primary location

Bauru School of Dentistry

Bauru, São Paulo, 17012-901, Brazil

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Gestational diabetes mellitus

Other

Primary outcomes

  1. 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.

  2. 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)

  3. 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

  1. Dyslipidemia as an indicator of obesity/insulin resistance

    Time frame: one day

    The data was registered in the patient's medical chart. Dyslipidemia = HDL ≤ 35 mg/dL / LDL≥ 100 mg/dL / Total cholesterol ≥200 mg/dL / Triglycerides ≥ 150 mg/dL / VLDL < 30 mg/dL

  2. Leukocytosis as an indicator of inflammation

    Time frame: one day

    The data was registered in the patient's medical chart.

    ≥ 10.000/L

Sponsors and collaborators

Lead sponsor

University of Sao Paulo

Other

Registry information

Official study title

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

Important dates

Study start
2007
Primary completion
2016
Study completion
2016
First posted
Sep 16, 2016
Registry last updated
Sep 16, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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