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

This study is currently recruiting participants. (see Contacts and Locations)
Verified January 2015 by Anemia Working Group Romania
Information provided by (Responsible Party):
Oana Slusanschi, Anemia Working Group Romania Identifier:
First received: January 29, 2013
Last updated: January 14, 2015
Last verified: January 2015
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: 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.


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

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 identifier: NCT01785355

Contact: Oana Slusanschi, DMD +40722266279
Contact: Liliana Garneata, MD +40722619358

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

Responsible Party: Oana Slusanschi, DMD, Anemia Working Group Romania Identifier: NCT01785355     History of Changes
Other Study ID Numbers: 005  00022 
Study First Received: January 29, 2013
Last Updated: January 14, 2015
Health Authority: Romania: Ministry of Public Health

Keywords provided by Anemia Working Group Romania:
periodontal disease
anemia response to ESA
quality of life

Additional relevant MeSH terms:
Gingival Diseases
Kidney Diseases
Periodontal Diseases
Renal Insufficiency, Chronic
Mouth Diseases
Renal Insufficiency
Stomatognathic Diseases
Urologic Diseases processed this record on May 26, 2016