NCT02903264

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
67

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Jan 2007

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2007

Completed
9.7 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

September 1, 2016

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2016

Completed
5 days until next milestone

First Submitted

Initial submission to the registry

September 6, 2016

Completed
10 days until next milestone

First Posted

Study publicly available on registry

September 16, 2016

Completed
Last Updated

September 16, 2016

Status Verified

September 1, 2016

Enrollment Period

9.7 years

First QC Date

September 6, 2016

Last Update Submit

September 12, 2016

Conditions

Diabetes Mellitus, GestationalPeriodontal DiseasesObesity

Keywords

Gestational Diabetes MellitusObesityPeriodontal Disease

Outcome Measures

Primary Outcomes (3)

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

    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.

    One day

  • Obesity measured by a tape and a scale

    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)

    one day

  • Gestational diabetes mellitus diagnosed by an endocrinologist

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

    one day

Secondary Outcomes (2)

  • Dyslipidemia as an indicator of obesity/insulin resistance

    one day

  • Leukocytosis as an indicator of inflammation

    one day

Study Arms (2)

GDM group

Gestational diabetes mellitus patients under treatment of an endocrinologist

Other: Gestational diabetes mellitus

Control

Healthy non-pregnant females

Interventions

Gestational diabetes mellitusOTHER
GDM group

Eligibility Criteria

Age18 Years - 42 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Only female participants

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Bauru School of Dentistry

Bauru, São Paulo, 17012-901, Brazil

Location

Related Publications (1)

  • Xie Y, Xiong X, Elkind-Hirsch KE, Pridjian G, Maney P, Delarosa RL, Buekens P. Prepregnancy obesity and periodontitis among pregnant females with and without gestational diabetes mellitus. J Periodontol. 2014 Jul;85(7):890-8. doi: 10.1902/jop.2013.130502. Epub 2013 Dec 19.

    PMID: 24354652BACKGROUND

MeSH Terms

Conditions

Diabetes, GestationalPeriodontal DiseasesObesity

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesMouth DiseasesStomatognathic DiseasesOverweightOvernutritionNutrition DisordersBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Carla Damante, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Associate professor

Study Record Dates

First Submitted

September 6, 2016

First Posted

September 16, 2016

Study Start

January 1, 2007

Primary Completion

September 1, 2016

Study Completion

September 1, 2016

Last Updated

September 16, 2016

Record last verified: 2016-09

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)