An interventional study of Non-surgical periodontal treatment in Type 2 Diabetes Mellitus With Periodontal Disease, sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho. Completed at 1 site in Brazil. Open to participants aged 35 Years and older. Per ClinicalTrials.gov, last updated 2018-11-14.
Sponsored by Universidade Estadual Paulista Júlio de Mesquita Filho · Not applicable, Interventional, and Treatment
Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity of PD, and this may contribute to the overall inflammatory burden of the individual, influencing the natural course DM2. The aim of this study is to establish whether individuals with DM with or without chronic periodontitis have an increase in oxLDL and what is the influence of periodontal treatment in the reduction of oxLDL with consequent improvement in Diabetes Mellitus parameters.
Periodontal disease (PD) and diabetes mellitus type 2 (DM2) have the same inflammatory etiopathogenesis and demonstrate a bidirectional relationship, for DM2 affects the severity of PD, and this may contribute to the overall inflammatory burden of the individual, influencing the natural course DM2. The aim of this study is to establish whether individuals with DM with or without chronic periodontitis have an increase in oxLDL and what is the influence of periodontal treatment in the reduction of oxLDL with consequent improvement in Diabetes Mellitus parameters. 44 patients will be divided into 2 groups: Diabetic Patients with Chronic Periodontitis (DM2DP) and Diabetic Patients without Chronic Periodontitis (DM2). The DM2DP group will receive periodontal debridement and DM2 group will be treated with supragingival scaling. Both groups receive board control every 3 months. At baseline, 3 and 6 months after treatment, will be held making the clinical periodontal parameters (plaque index, gingival index, probing depth, gingival recession relative clinical attachment level and Periodontal Inflamed Surface Area (PISA) index) and blood collection for assessment serum inflammatory markers (oxLDL, LDL, HDL, total cholesterol, triglyceride, Interleukin (IL) IL-6, IL-8, IL-10, Tumor Necrosis Factor (TNF-α) and CRP). Biochemical analyzes will be carried out by Z-scan technique. The data obtained before and after periodontal therapy will be analyzed using the Shapiro-Wilk test.
830 studies on the registry are indexed under Periodontal Diseases; 189 are open to participants now.
This study's enrollment of 44 is close to the median of 45 across 530 interventional studies indexed under Periodontal Diseases.
Browse Periodontal Diseases studies →Universidade Estadual Paulista Júlio de Mesquita Filho is the lead sponsor of 82 studies on the registry; 9 are open to participants now.
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Exclusion Criteria:
periodontal debridement in a single session.
Procedure: Non-surgical periodontal treatment
maintained every three months.
Debridement in a single session in which patients will be anesthetized and receive scaling and root planing with ultrasound equipment .
Probing depth change
The change in the probing depth will be measure in millimeters before and after the treatment.
Time frame: baseline, 90 and 180 days
oxLDL concentration Change
Change in concentration of oxLDL will be measured before and treatment.
Time frame: baseline and 180 days
LDL, HDL, Total cholesterol, Triacylglycerol
Blood concentration (g/ml) will be measured before and after periodontal therapy.
Time frame: baseline and 180 days
Plaque index
Number of teeth affected before and after periodontal treatment
Time frame: baseline, 90 and 180 days
Gingival index
number of teeth affected before and after periodontal treatment
Time frame: baseline, 90 and 180 days
Gingival Recession
Evaluated in millimeters before and after the treatment.
Time frame: baseline, 90 and 180 days
Clinical Attachment Level
Evaluated in millimeters before and after the treatment.
Time frame: baseline, 90 and 180 days
Plan to share: No
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This study is completed, as verified in Nov 2018. You cannot join it, but the record below documents what was studied.
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Universidade Estadual Paulista Júlio de Mesquita Filho