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

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

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).

Study Overview

• Status: Unknown
• Conditions: Chronic Kidney Disease; Periodontal Disease
• Intervention / Treatment: 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 Type: Observational
• Enrollment (Anticipated): 30

Contacts and Locations

Study Locations

• Romania
  • Bucharest, Romania
    • Recruiting
    • CMI "Dr Slusanschi Oana"
    • Contact: Oana Slusanschi, DMD; Phone Number: +40722266279; Email: oanciu@yahoo.com
    • Principal Investigator: Oana Slusanschi, DMD

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Probability Sample

Study Population

Haemodialyzed patients with Periodontal Disease

Description

Inclusion Criteria:

• Hemodialyzed patients with periodontal disease

Exclusion Criteria:

• Malignancies, Diabetes
• Patient refusal to participate

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

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; The preliminary stage deals with:assessment of the clinical state of the patient by completing a detailed dental and periodontal charteducation of the patient regarding correct oral hygiene habits;; Phase I Therapy:plaque control : removal of dental plaque, calculus and root planning; antimicrobial therapy (local or systemic)evaluation of response to the treatment; Phase II Therapy - surgical phase:extraction of hopeless teethevaluation of the surgical results.; Maintenance phase:periodic reevaluation of plaque and calculus and of periodontal conditions.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modification of nutritional status	SGA, whole body bioimpedance, biochemical parameters (serum albumin, predialysis serum urea, serum creatinine, serum phosphates)	6 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modification of inflammatory status	C Reactive Protein	6 months

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Modification of periodontal disease index	Modification of periodontal disease index assessed by the CAL, PPD, bleeding index	3 months
Modification of the quality of life, as assessed by SF-36 and OHIP-14	Modification of the quality of life, as assessed by SF-36 and OHIP-14	6 months
Modification of anaemia response to epoetin	Modification of anaemia response to epoetin, as assessed by the ERI and by the cumulative ESAs dose	6 months

Collaborators and Investigators

• Sponsor: Anemia Working Group Romania
• Investigators: Principal Investigator: Oana Slusanschi, DMD, University of Medicine and Pharmacy Bucharest

Study record dates

Study Major Dates

• Study Start (Actual): September 1, 2012
• Primary Completion (Anticipated): September 1, 2021
• Study Completion (Anticipated): June 1, 2022

Study Registration Dates

• First Submitted: January 29, 2013
• First Submitted That Met QC Criteria: February 6, 2013
• First Posted (Estimate): February 7, 2013

Study Record Updates

• Last Update Posted (Actual): July 23, 2019
• Last Update Submitted That Met QC Criteria: July 20, 2019
• Last Verified: July 1, 2019

More Information

Terms related to this study

• Keywords: quality of life; nutrition; CKD; inflammation; hemodialysis; periodontal disease; anemia response to ESA
• Additional Relevant MeSH Terms: Urologic Diseases; Renal Insufficiency; Stomatognathic Diseases; Mouth Diseases; Kidney Diseases; Renal Insufficiency, Chronic; Periodontal Diseases
• Other Study ID Numbers: 005; 00022 (Registry Identifier: Romanian Renal Registry)