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

Periodontal Disease, Inflammation, Nutritional Status And Anaemia Response To Erythropoietin In Chronic Haemodialyzed Patients - The Impact Of Treatment For Periodontal Disease

Status
UNKNOWN
Phases
Unknown
Study type
Observational
Source
ClinicalTrials.gov
Registry ID
NCT01785355
Acronym
PAROHEM
Enrollment
30
Registered
2013-02-07
Start date
2012-09-30
Completion date
2022-06-30
Last updated
2019-07-23

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease, Periodontal Disease

Keywords

periodontal disease, CKD, nutrition, inflammation, anemia response to ESA, quality of life, hemodialysis

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.

Interventions

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.

Sponsors

Anemia Working Group Romania
Lead SponsorOTHER

Study design

Observational model
COHORT
Time perspective
PROSPECTIVE

Eligibility

Sex/Gender
ALL
Age
18 Years to 85 Years
Healthy volunteers
No

Inclusion criteria

* Hemodialyzed patients with periodontal disease

Exclusion criteria

* Malignancies, Diabetes * Patient refusal to participate

Design outcomes

Primary

MeasureTime frameDescription
Modification of nutritional status6 monthsSGA, whole body bioimpedance, biochemical parameters (serum albumin, predialysis serum urea, serum creatinine, serum phosphates)

Secondary

MeasureTime frameDescription
Modification of inflammatory status6 monthsC Reactive Protein

Other

MeasureTime frameDescription
Modification of periodontal disease index3 monthsModification of periodontal disease index assessed by the CAL, PPD, bleeding index
Modification of the quality of life, as assessed by SF-36 and OHIP-146 monthsModification of the quality of life, as assessed by SF-36 and OHIP-14
Modification of anaemia response to epoetin6 monthsModification of anaemia response to epoetin, as assessed by the ERI and by the cumulative ESAs dose

Countries

Romania

Contacts

Primary ContactOana Slusanschi, DMD
oanciu@yahoo.com+40722266279
Backup ContactLiliana Garneata, MD
lilianagarna@yahoo.com+40722619358

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026