The Impact Of Periodontal Disease Treatment On The General Health Status In Chronic Haemodialyzed Patients

Study Overview
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Brief Summary
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Several studies revealed a direct relationship between the severity of periodontal inflammation and CRP (NHANES III, Dumitriu HT et al, 1998). In patients without any other source of inflammation but PDD, proper dental treatment of the disease decreased CRP to normal levels (Dumitriu H.T. et al., 1998; D'Aiuto F. et al, 2004; Borawski J. et al., 2007) Moreover, a direct link between high levels of CRP and atherosclerotic complications has been found in studies conducted both in general population (Ridker PM, et al., 1998; Koenig W, et al., 1999) and in HD subjects (Westhuyzen J, et al., 2000; Iseki K., et al., 1999; Zimmermann J, et al. 1998).

Detailed Description
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Patients will be recruited according to eligibility criteria. Initial oral and general status will be evaluated and recorded. The evaluated parameters are listed at the study description section. Also, quality of life will be assessed by using the SF-36 and OHIP-14 questionnaires. Patients will undergo a series of dental interventions with the final scope of eliminating all oral inflammation. Participants will also be instructed regarding correct oral hygiene habits. Following dental and periodontal treatments, the oral and general status will be reassessed and the obtained dat analysed.

Official Title
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Periodontal Disease, Inflammation, Nutritional Status And Anaemia Response To Erythropoietin In Chronic Haemodialyzed Patients - The Impact Of Treatment For Periodontal Disease

Conditions
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Periodontal Disease, Chronic Kidney Disease

Intervention / Treatment
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* Other: Dental treatment


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Hemodialyzed patients with periodontal disease Exclusion Criteria: Malignancies, Diabetes Patient refusal to participate

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 85 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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Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Dental treatment<br>Assessment of the clinical state of the patient. Professional prophylaxis and removal of calculus. Extraction of hopeless teeth.Education of patient for oral hygiene. Periodic reevaluation. | Other: Dental treatment<br>* The preliminary stage deals with: assessment of the clinical state of the patient by completing a detailed dental and periodontal chart education of the patient regarding correct oral hygiene habits; Phase I Therapy: plaque control : removal of dental plaque, calculus and root planning; antimicrobial therapy (local or systemic) evaluation of response to the treatment Phase II Therapy - surgical phase: extraction of hopeless teeth evaluation of the surgical results. Maintenance phase: periodic reevaluation of plaque and calculus and of periodontal conditions.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modification of nutritional status | SGA, whole body bioimpedance, biochemical parameters (serum albumin, predialysis serum urea, serum creatinine, serum phosphates) | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Modification of inflammatory status | C Reactive Protein | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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periodontal disease, CKD, nutrition, inflammation, anemia response to ESA, quality of life, hemodialysis