oxLDL in Diabetes Mellitus Patients and Disease Periodontal
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|ClinicalTrials.gov Identifier: NCT03198832|
Recruitment Status : Completed
First Posted : June 26, 2017
Last Update Posted : November 14, 2018
|Condition or disease||Intervention/treatment||Phase|
|Type 2 Diabetes Mellitus With Periodontal Disease||Procedure: Non-surgical periodontal treatment||Not Applicable|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||44 participants|
|Intervention Model:||Parallel Assignment|
|Intervention Model Description:||Prospective double-blind controlled clinical study with a 6-month follow-up.|
|Masking:||Double (Participant, Outcomes Assessor)|
|Official Title:||Disease Periodontal Influence on Markers of Cardiovascular in Diabetes Mellitus Patients|
|Actual Study Start Date :||May 2, 2016|
|Actual Primary Completion Date :||August 26, 2016|
|Actual Study Completion Date :||January 28, 2017|
Sham Comparator: Type 2 diabetes mellitus and periodontitis
periodontal debridement in a single session.
Procedure: Non-surgical periodontal treatment
Debridement in a single session in which patients will be anesthetized and receive scaling and root planing with ultrasound equipment .
No Intervention: Type 2 diabetes mellitus and without periodontitis
maintained every three months.
- Probing depth change [ Time Frame: baseline, 90 and 180 days ]The change in the probing depth will be measure in millimeters before and after the treatment.
- oxLDL concentration Change [ Time Frame: baseline and 180 days ]Change in concentration of oxLDL will be measured before and treatment.
- LDL, HDL, Total cholesterol, Triacylglycerol [ Time Frame: baseline and 180 days ]Blood concentration (g/ml) will be measured before and after periodontal therapy.
- Plaque index [ Time Frame: baseline, 90 and 180 days ]Number of teeth affected before and after periodontal treatment
- Gingival index [ Time Frame: baseline, 90 and 180 days ]number of teeth affected before and after periodontal treatment
- Gingival Recession [ Time Frame: baseline, 90 and 180 days ]Evaluated in millimeters before and after the treatment.
- Clinical Attachment Level [ Time Frame: baseline, 90 and 180 days ]Evaluated in millimeters before and after the treatment.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03198832
|São Jose dos Campos, São Paulo, Brazil, 12245 000|
|Study Director:||Maria Jardini, PhD||Universidade Estadual Paulista Julio de Mesquita Filho|