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Clinical Trials/NCT01785355
NCT01785355
Unknown
Not Applicable

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

Anemia Working Group Romania1 site in 1 country30 target enrollmentSeptember 2012

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Periodontal Disease
Sponsor
Anemia Working Group Romania
Enrollment
30
Locations
1
Primary Endpoint
Modification of nutritional status
Last Updated
6 years ago

Overview

Brief Summary

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

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.

Registry
clinicaltrials.gov
Start Date
September 2012
End Date
June 2022
Last Updated
6 years ago
Study Type
Observational
Sex
All

Investigators

Sponsor
Anemia Working Group Romania
Responsible Party
Principal Investigator
Principal Investigator

Oana Slusanschi

DMD

Anemia Working Group Romania

Eligibility Criteria

Inclusion Criteria

  • Hemodialyzed patients with periodontal disease

Exclusion Criteria

  • Malignancies, Diabetes
  • Patient refusal to participate

Outcomes

Primary Outcomes

Modification of nutritional status

Time Frame: 6 months

SGA, whole body bioimpedance, biochemical parameters (serum albumin, predialysis serum urea, serum creatinine, serum phosphates)

Secondary Outcomes

  • Modification of inflammatory status(6 months)

Study Sites (1)

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