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Periodontal and Salivary Evaluation of Type 1 Diabetes Mellitus Patients

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

Status
Completed
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT02935868
Enrollment
30
Registered
2016-10-18
Start date
2013-11-30
Completion date
2016-09-30
Last updated
2016-10-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Diabetes Mellitus, Type 1, Periodontal Diseases

Keywords

Saliva

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.

Interventions

None listed

Sponsors

University of Sao Paulo
Lead SponsorOTHER

Study design

Observational model
CASE_CONTROL
Time perspective
CROSS_SECTIONAL

Eligibility

Sex/Gender
ALL
Age
18 Years to 35 Years
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

Design outcomes

Primary

MeasureTime frameDescription
Periodontal disease (gingivitis and periodontitis) measured by a periodontal probe and classified according to severityone daySevere 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%.
Salivary pH and buffering Capacity - collection of stimulated saliva in 10 minutes and measurement of acidity with a pHmeterone dayNormal 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 glucose - collection of stimulated saliva in 10 minutes and measurement with a colorimetric kitone daySalivary 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.
Salivary peroxidase - collection of stimulated saliva in 10 minutes, measurement by a spectrophotometer.one dayThe activity of salivary peroxidase is presented in Units/mg. The detection of activity of these enzymes is associated to periodontal disease.

Secondary

MeasureTime frameDescription
Plaque index - measured by visual observation and classification in scores (1 for presence, 0 for absence)One dayPlaque index (PI) will be registered as scores (1 for presence, 0 for absence). For control group a plaque index of 15% is considered normal.

Countries

Brazil

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026