Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
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

Study Description
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information
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).

Condition or disease Intervention/treatment
Periodontal Disease Chronic Kidney Disease Other: Dental treatment

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 Design
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Periodontal Disease, Inflammation, Nutritional Status And Anaemia Response To Erythropoietin In Chronic Haemodialyzed Patients - The Impact Of Treatment For Periodontal Disease
Actual Study Start Date : September 2012
Estimated Primary Completion Date : September 2021
Estimated Study Completion Date : June 2022

Resource links provided by the National Library of Medicine


Groups and Cohorts
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort Intervention/treatment
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.


Outcome Measures
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. 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 :
  1. Modification of inflammatory status [ Time Frame: 6 months ]
    C Reactive Protein


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

  2. 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

  3. 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


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Information from the National Library of Medicine

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, Learn About Clinical Studies.


Layout table for eligibility information
Ages Eligible for Study:   18 Years to 85 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Probability Sample
Study Population
Haemodialyzed patients with Periodontal Disease
Criteria

Inclusion Criteria:

  • Hemodialyzed patients with periodontal disease

Exclusion Criteria:

  • Malignancies, Diabetes
  • Patient refusal to participate
Contacts and Locations
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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
Layout table for location contacts
Contact: Oana Slusanschi, DMD +40722266279 oanciu@yahoo.com
Contact: Liliana Garneata, MD +40722619358 lilianagarna@yahoo.com

Locations
Layout table for location information
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
Layout table for investigator information
Principal Investigator: Oana Slusanschi, DMD University of Medicine and Pharmacy Bucharest
More Information
Go to 
Top of Page Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for additonal 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 Posted: February 7, 2013    Key Record Dates
Last Update Posted: July 23, 2019
Last Verified: July 2019
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:
Layout table for MeSH terms
Periodontal Diseases
Kidney Diseases
Renal Insufficiency, Chronic
Urologic Diseases
 Renal Insufficiency
Mouth Diseases
Stomatognathic Diseases