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

This study is ongoing, but not recruiting participants.
Sponsor:
Information provided by (Responsible Party):
Oana Slusanschi, Anemia Working Group Romania
ClinicalTrials.gov Identifier:
NCT01785355
First received: January 29, 2013
Last updated: August 5, 2013
Last verified: August 2013
  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: Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: 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 Anemia Working Group Romania:

Primary Outcome Measures:
  • Modification of nutritional status [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    C Reactive Protein


Other Outcome Measures:
  • Modification of periodontal disease index [ Time Frame: 3 months ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    Modification of the quality of life, as assessed by SF-36 and OHIP-14

  • Modification of anaemia response to epoetin [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    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: March 2014
Estimated Primary Completion Date: October 2013 (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

Ages Eligible for Study:   20 Years to 85 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Hemodialyzed patients with periodontal disease

Exclusion Criteria:

  • Malignancies, Diabetes
  • Patient refusal to participate
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01785355

Locations
Romania
CMI "Dr Slusanschi Oana"
Bucharest, Romania
Sponsors and Collaborators
Anemia Working Group Romania
Investigators
Principal Investigator: Oana Slusanschi, DMD University of Medicine and Pharmacy Bucharest
  More Information

No publications provided

Responsible Party: Oana Slusanschi, DMD, Anemia Working Group Romania
ClinicalTrials.gov Identifier: NCT01785355     History of Changes
Other Study ID Numbers: 005, 00022
Study First Received: January 29, 2013
Last Updated: August 5, 2013
Health Authority: Romania: Ministry of Public Health

Keywords provided by 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
Urologic Diseases
Renal Insufficiency
Mouth Diseases
Stomatognathic Diseases

ClinicalTrials.gov processed this record on October 02, 2014