Periodontal and Salivary Evaluation of Type 1 Diabetes Mellitus Patients

Completed

• Conditions: Diabetes Mellitus, Type 1; Periodontal Diseases

• Registration Number: NCT02935868
• Lead Sponsor: University of Sao Paulo

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.

Detailed Description

Not available

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study Start: 2013-11
• Primary Completion: 2016-09
• Study Completion: 2016-09
• Study First Submitted: 2016-09-29
• Status Verified: 2016-10
• Study First Submitted QC: 2016-10-13
• Last Update Submitted: 2016-10-13
• Study First Posted: 2016-10-18
• Last Update Posted: 2016-10-18

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Salivary pH and buffering Capacity - collection of stimulated saliva in 10 minutes and measurement of acidity with a pHmeter	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.	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	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	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 Outcome Measures

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

Trial Locations

Locations (1)

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