Periodontal and Salivary Evaluation of Type 1 Diabetes Mellitus Patients

Study Overview
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Brief Summary
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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.

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

Conditions
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Diabetes Mellitus, Type 1, Periodontal Diseases

Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 35 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Test group<br>Patients with Type 1 diabetes mellitus | |
| Control Group<br>Patients without systemic diseases | |

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| 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 (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%. | one day | 
| Salivary pH and buffering Capacity - collection of stimulated saliva in 10 minutes and measurement of acidity with a pHmeter | 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'' | one day | 
| Salivary glucose - collection of stimulated saliva in 10 minutes and measurement with a colorimetric kit | 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. | one day | 
| Salivary peroxidase - collection of stimulated saliva in 10 minutes, measurement by a spectrophotometer. | The activity of salivary peroxidase is presented in Units/mg. The detection of activity of these enzymes is associated to periodontal disease. | one day | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Plaque index - measured by visual observation and classification in scores (1 for presence, 0 for absence) | 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. | One day | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Saliva