Skip to main content
Clinical Trials/NCT02935868
NCT02935868CompletedNot Applicable

Periodontal and Salivary Evaluation of a Sample of Type 1 Diabetes Mellitus Patients in Brazil

University of Sao Paulo1 site in 1 country30 target enrollmentStarted: November 2013Last updated:
Conditions

Trial Snapshot

Phase
Not Applicable
Status
Completed
Enrollment
30
Locations
1
Primary Endpoint
Salivary pH and buffering Capacity - collection of stimulated saliva in 10 minutes and measurement of acidity with a pHmeter

Study Overview

Brief Summary

Diabetes Mellitus is a risk factor for periodontal disease increasing its prevalence, extension and severity. Periodontal disease is considered the sixth complication of diabetes. There is a global epidemic of diabetes, including an increase of incidence of type 1 diabetes in younger patients. Thus, the aim of this observational study was to evaluate the periodontal and salivary condition of a sample of patients with type 1 diabetes of a brazillian city.

Study Design

Study Type
Observational
Observational Model
Case Control
Time Perspective
Cross Sectional

Eligibility Criteria

Ages
18 Years to 35 Years (Adult)
Sex
All
Accepts Healthy Volunteers
Yes

Inclusion Criteria

  • Diagnose of Type 1 diabetes mellitus
  • Age between 18 and 35 years old
  • Presenting on tooth per quadrant

Exclusion Criteria

  • Diagnose of Type 2 diabetes mellitus
  • Edentulous patients
  • Other systemic diseases

Outcomes

Primary Outcomes

Salivary pH and buffering Capacity - collection of stimulated saliva in 10 minutes and measurement of acidity with a pHmeter

Time Frame: one day

Normal Salivary pH = 6 to 7. Buffering capacity: ≥ 5.6 were considered as ''high'', ranging from 4.1 to 5.5 were labelled as ''medium'' and those ≤4 were defined as ''low''

Salivary peroxidase - collection of stimulated saliva in 10 minutes, measurement by a spectrophotometer.

Time Frame: one day

The activity of salivary peroxidase is presented in Units/mg. The detection of activity of these enzymes is associated to periodontal disease.

Salivary glucose - collection of stimulated saliva in 10 minutes and measurement with a colorimetric kit

Time Frame: one day

Salivary glucose is measured by a colorimetric kit and the values are converted and presented as mg/dL. There are no reference value for this measurement. The analysis is done by means of correlation to blood glucose levels in mg/dL.

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 (clinical attachment level) ≥ 6mm and ≥1 interproximal site with PPD (periodontal probing depth) ≥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 (bleeding on probing) extent scores \< 10% and with gingivitis if presented PPD ≤3mm/ BOP extent scores \>10%.

Secondary Outcomes

  • Plaque index - measured by visual observation and classification in scores (1 for presence, 0 for absence)(One day)

Investigators

Sponsor Class
Other
Responsible Party
Principal Investigator
Principal Investigator

Carla Andreotti Damante

Associate professor

University of Sao Paulo

Study Sites (1)

Loading locations...

Similar Trials

Periodontal and Salivary Evaluation of... | Clinical Trial