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

• Conditions: Periodontal Disease; Chronic Kidney Disease
• Interventions: Other: Dental treatment

• Registration Number: NCT01785355
• Lead Sponsor: Anemia Working Group Romania

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 Timeline

• Study Start: 2012-09
• Study First Submitted: 2013-01-29
• Study First Submitted QC: 2013-02-06
• Study First Posted: 2013-02-07
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-20
• Last Update Posted: 2019-07-23
• Primary Completion: 2021-09
• Study Completion: 2022-06

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 30

Inclusion Criteria

• Hemodialyzed patients with periodontal disease

Exclusion Criteria

• Malignancies, Diabetes
• Patient refusal to participate

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Dental 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.

Primary Outcome Measures

Name	Time	Method
Modification of nutritional status	6 months	SGA, whole body bioimpedance, biochemical parameters (serum albumin, predialysis serum urea, serum creatinine, serum phosphates)

Secondary Outcome Measures

Name	Time	Method
Modification of inflammatory status	6 months	C Reactive Protein

Trial Locations

Locations (1)

CMI "Dr Slusanschi Oana"; 🇷🇴 Bucharest, Romania