Clinical and Microbiological Evaluation of Periodontal Treatment of Diabetic Patients: A Longitudinal Study

Study Overview
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Brief Summary
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The purpose of this study is to determine whether periodontal treatment improves the periodontal clinical parameters in the periodontal patients with diabetes regarding non-diabetics: two years follow-up.

Detailed Description
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All the subjects in the study will receive non surgical periodontal treatment in one session (full-mouth scaling and root planing). Clinical parameters will be assessed in all teeth (except third molars) by one experienced and trained examiner before treatment and every 3 months for 2 years. Visible plaque index (VPI) will be represented a mean percentage of sites with visible plaque calculated for all teeth analyzed (four sites per tooth). Others parameters will be assessed at six sites per tooth using a manual periodontal probe (15mm). Bleeding on probing (BOP) will be represented the mean percentage of sites with bleeding (up to 15 seconds after probing) calculated for all teeth analyzed. Probing depth (PD - distance between the gingival margin and the bottom of the sulcus/pocket), gingival recession (GR - distance between the cementoenamel junction and gingival margin) and clinical attachment level (CAL - distance between the cementoenamel junction and the bottom of the sulcus/pocket) will be represented a mean distance calculated per site for all teeth analyzed. For blood parameters, an outside laboratory will perform all blood analysis. It will be requested for each subject with diabetes (DG) at baseline, each 3 months post-treatment. Fasting plasma glucose (FPG) will be expressed in milligrams per deciliter and HbA1c will be expressed as a percentage. Statistical analysis will be performed using an available software program and the patient will be considered as the unit of analysis.The data will be processed and analyzed by descriptive and inferential statistics, probably nonparametric.

Official Title
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Clinical and Microbiological Evaluation of Non-surgical Periodontal Treatment of Diabetic and Non-diabetic Patients: A Longitudinal Study

Conditions
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Chronic Periodontitis, Diabetes Mellitus, Type 2

Intervention / Treatment
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* Procedure: Full Mouth Scaling and Root Planing


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Clinical diagnosis of chronical periodontitis according to Lopez et al. 2002 (one or more teeth with at least one site with PD >= 4mm or CAL >= 3mm); And have at least 8 natural teeth (excluding third molars), and older than 18 years and of both genders. Exclusion Criteria: Any systemic diseases or complications (except Type 2 Diabetes Mellitus) such as cardiovascular disease, Alzheimer's, lung or brain diseases and metabolic syndrome; Use of antibiotics or periodontal treatment within the past 6 months; Long-term administration of anti-inflammatory or/and immunosuppressive agents; Current smoker or former smoker for the past 5 years; Pregnant or breastfeeding; And presence of orthodontic appliances.

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Diagnostic
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Diabetic group<br>Subjects with Chronic Periodontitis and Type 2 Diabetes Mellitus treated with non surgical periodontal therapy (Full Mouth Scaling and Root Planing) | Procedure: Full Mouth Scaling and Root Planing<br>* This procedure was performed as described by Quirynen et al. 2005 with some modifications<br>|
| Experimental: Nondiabetic group<br>Subjects with Chronic Periodontitis and without Type 2 Diabetes Mellitus treated with non surgical periodontal therapy (Full Mouth Scaling and Root Planing) | Procedure: Full Mouth Scaling and Root Planing<br>* This procedure was performed as described by Quirynen et al. 2005 with some modifications<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of bleeding on probing | The mean percentage of periodontal sites with bleeding on probing | Baseline | 
| Percentage of bleeding on probing | The mean percentage of periodontal sites with bleeding on probing | at three months | 
| Percentage of bleeding on probing | The mean percentage of periodontal sites with bleeding on probing | at six months | 
| Percentage of bleeding on probing | The mean percentage of periodontal sites with bleeding on probing | at nine months | 
| Percentage of bleeding on probing | The mean percentage of periodontal sites with bleeding on probing | at twelve months | 
| Percentage of bleeding on probing | The mean percentage of periodontal sites with bleeding on probing | at eighteen months | 
| Percentage of bleeding on probing | The mean percentage of periodontal sites with bleeding on probing | at twenty four months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Percentage of visible plaque index | The mean percentage of periodontal sites with visible plaque | Baseline and at three, six, nine, twelve, eighteen and twenty four months | 
| Probing depth (mm) | The mean of probing depth in millimeters calculated for periodontal sites. | Baseline and at three, six, nine, twelve, eighteen and twenty four months | 
| Clinical attachment level (mm) | The mean of clinical attachment level in millimeters calculated for periodontal sites. | Baseline and at three, six, nine, twelve, eighteen and twenty four months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Dental Scaling, Blood Glucose, Hemoglobin A, Glycosylated