Gestational Diabetes Mellitus, Obesity and Periodontal Disease

Completed

• Conditions: Diabetes Mellitus, Gestational; Periodontal Diseases; Obesity

• Registration Number: NCT02903264
• Lead Sponsor: University of Sao Paulo

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 Timeline

• Study Start: 2007-01
• Status Verified: 2016-09
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Submitted: 2016-09-06
• Study First Submitted QC: 2016-09-12
• Last Update Submitted: 2016-09-12
• Study First Posted: 2016-09-16
• Last Update Posted: 2016-09-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 67

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severity	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	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	one day	Diagnosis stablished by a doctor based on glucose determination. The data was registered in the patient's medical chart.

Secondary Outcome Measures

Name	Time	Method
Dyslipidemia as an indicator of obesity/insulin resistance	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
Leukocytosis as an indicator of inflammation	one day	The data was registered in the patient's medical chart.; ≥ 10.000/L

Trial Locations

Locations (1)

Bauru School of Dentistry; 🇧🇷 Bauru, Sao Paulo, Brazil