Periodontal and Salivary Evaluation of a Sample of Type 1 Diabetes Mellitus Patients in Brazil
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sao Paulo
- 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
Carla Andreotti Damante
Associate professor
University of Sao Paulo
