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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified January 2015 by Oana Slusanschi, Anemia Working Group Romania.
Recruitment status was:  Recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT01785355
First Posted: February 7, 2013
Last Update Posted: January 15, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Oana Slusanschi, Anemia Working Group Romania
  Purpose
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).

Condition Intervention
Periodontal Disease Chronic Kidney Disease Other: Dental treatment

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Periodontal Disease, Inflammation, Nutritional Status And Anaemia Response To Erythropoietin In Chronic Haemodialyzed Patients - The Impact Of Treatment For Periodontal Disease

Resource links provided by NLM:


Further study details as provided by Oana Slusanschi, Anemia Working Group Romania:

Primary Outcome Measures:
  • Modification of nutritional status [ Time Frame: 6 months ]
    SGA, whole body bioimpedance, biochemical parameters (serum albumin, predialysis serum urea, serum creatinine, serum phosphates)


Secondary Outcome Measures:
  • Modification of inflammatory status [ Time Frame: 6 months ]
    C Reactive Protein


Other Outcome Measures:
  • Modification of periodontal disease index [ Time Frame: 3 months ]
    Modification of periodontal disease index assessed by the CAL, PPD, bleeding index

  • Modification of the quality of life, as assessed by SF-36 and OHIP-14 [ Time Frame: 6 months ]
    Modification of the quality of life, as assessed by SF-36 and OHIP-14

  • Modification of anaemia response to epoetin [ Time Frame: 6 months ]
    Modification of anaemia response to epoetin, as assessed by the ERI and by the cumulative ESAs dose


Estimated Enrollment: 30
Study Start Date: September 2012
Estimated Study Completion Date: June 2016
Estimated Primary Completion Date: January 2016 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Dental treatment
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
  1. 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;
  2. Phase I Therapy:

    • plaque control : removal of dental plaque, calculus and root planning; antimicrobial therapy (local or systemic)
    • evaluation of response to the treatment
  3. Phase II Therapy - surgical phase:

    • extraction of hopeless teeth
    • evaluation of the surgical results.
  4. Maintenance phase:

    • periodic reevaluation of plaque and calculus and of periodontal conditions.

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   20 Years to 85 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hemodialyzed patients with periodontal disease

Exclusion Criteria:

  • Malignancies, Diabetes
  • Patient refusal to participate
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01785355


Contacts
Contact: Oana Slusanschi, DMD +40722266279 oanciu@yahoo.com
Contact: Liliana Garneata, MD +40722619358 lilianagarna@yahoo.com

Locations
Romania
CMI "Dr Slusanschi Oana" Recruiting
Bucharest, Romania
Contact: Oana Slusanschi, DMD    +40722266279    oanciu@yahoo.com   
Principal Investigator: Oana Slusanschi, DMD         
Sponsors and Collaborators
Anemia Working Group Romania
Investigators
Principal Investigator: Oana Slusanschi, DMD University of Medicine and Pharmacy Bucharest
  More Information

Responsible Party: Oana Slusanschi, DMD, Anemia Working Group Romania
ClinicalTrials.gov Identifier: NCT01785355     History of Changes
Other Study ID Numbers: 005
00022 ( Registry Identifier: Romanian Renal Registry )
First Submitted: January 29, 2013
First Posted: February 7, 2013
Last Update Posted: January 15, 2015
Last Verified: January 2015

Keywords provided by Oana Slusanschi, Anemia Working Group Romania:
periodontal disease
CKD
nutrition
inflammation
anemia response to ESA
quality of life
hemodialysis

Additional relevant MeSH terms:
Kidney Diseases
Renal Insufficiency, Chronic
Periodontal Diseases
Gingival Diseases
Urologic Diseases
Renal Insufficiency
Mouth Diseases
Stomatognathic Diseases