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

Chronic Kidney Disease Clinical Trial

— PAROHEM  

Official title:

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01785355
• Other study ID #: 005
• Secondary ID: 00022
• Status: Recruiting
• Start date: September 2012
• Est. completion date: June 2022

Study information

• Verified date: July 2019
• Source: Anemia Working Group Romania
• Contact: Oana Slusanschi, DMD
• Phone: +40722266279
• Email: oanciu[@]yahoo.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 30
• Est. completion date: June 2022
• Est. primary completion date: September 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 85 Years

Eligibility

Inclusion Criteria:

• Hemodialyzed patients with periodontal disease

Exclusion Criteria:

• Malignancies, Diabetes

• Patient refusal to participate

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Periodontal Disease
• Periodontal Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Dental treatment
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; 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 teeth evaluation of the surgical results. Maintenance phase: periodic reevaluation of plaque and calculus and of periodontal conditions.

Locations

Country	Name	City	State
Romania	CMI "Dr Slusanschi Oana"	Bucharest

Sponsors (1)

Lead Sponsor	Collaborator
Anemia Working Group Romania

Country where clinical trial is conducted

Romania, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	Modification of periodontal disease index	Modification of periodontal disease index assessed by the CAL, PPD, bleeding index	3 months
Other	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
Other	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
Primary	Modification of nutritional status	SGA, whole body bioimpedance, biochemical parameters (serum albumin, predialysis serum urea, serum creatinine, serum phosphates)	6 months
Secondary	Modification of inflammatory status	C Reactive Protein	6 months