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

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ClinicalTrials.gov Identifier: NCT01785355
Recruitment Status : Recruiting
First Posted : February 7, 2013
Last Update Posted : July 23, 2019
Sponsor:
Information provided by (Responsible Party):
Oana Slusanschi, Anemia Working Group Romania

Tracking Information
First Submitted Date January 29, 2013
First Posted Date February 7, 2013
Last Update Posted Date July 23, 2019
Actual Study Start Date September 2012
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: February 6, 2013)
Modification of nutritional status [ Time Frame: 6 months ]
SGA, whole body bioimpedance, biochemical parameters (serum albumin, predialysis serum urea, serum creatinine, serum phosphates)
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT01785355 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: February 6, 2013)
Modification of inflammatory status [ Time Frame: 6 months ]
C Reactive Protein
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: February 6, 2013)
  • 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
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title The Impact Of Periodontal Disease Treatment On The General Health Status In Chronic Haemodialyzed Patients
Official Title Periodontal Disease, Inflammation, Nutritional Status And Anaemia Response To Erythropoietin In Chronic Haemodialyzed Patients - The Impact Of Treatment For Periodontal Disease
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.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Probability Sample
Study Population Haemodialyzed patients with Periodontal Disease
Condition
  • Periodontal Disease
  • Chronic Kidney Disease
Intervention 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.
Study Groups/Cohorts 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.
Intervention: Other: Dental treatment
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: February 6, 2013)
30
Original Estimated Enrollment Same as current
Estimated Study Completion Date June 2022
Estimated Primary Completion Date September 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Hemodialyzed patients with periodontal disease

Exclusion Criteria:

  • Malignancies, Diabetes
  • Patient refusal to participate
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years to 85 Years   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Oana Slusanschi, DMD +40722266279 oanciu@yahoo.com
Contact: Liliana Garneata, MD +40722619358 lilianagarna@yahoo.com
Listed Location Countries Romania
Removed Location Countries  
 
Administrative Information
NCT Number NCT01785355
Other Study ID Numbers 005
00022 ( Registry Identifier: Romanian Renal Registry )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Oana Slusanschi, Anemia Working Group Romania
Study Sponsor Anemia Working Group Romania
Collaborators Not Provided
Investigators
Principal Investigator: Oana Slusanschi, DMD University of Medicine and Pharmacy Bucharest
PRS Account Anemia Working Group Romania
Verification Date July 2019