NCT04262011

Effect of Non-surgical Periodontal Treatment and C-reactive Protein Levels in Hemodialysis Patients

Effect of Non-surgical Periodontal Treatment on Renal Function and C-reactive Protein Levels in Hemodialysis Patients

• Status: Unknown
• Phase: N/A
• Study type: Interventional
• Enrollment: 88 (estimated)
• Sponsor: Universidade Federal de Santa Maria · Academic / Other
• Sex: All
• Age: 18 Years – 90 Years
• Healthy volunteers: Not accepted

Summary

The presence of periodontitis has been hypothesized as a risk factor for several systemic outcomes, including chronic kidney disease (CKD). Therefore, the aim of this study is to evaluate the impact of non-surgical periodontal treatment on CRP levels and quality of life of patients with chronic kidney disease undergoing hemodialysis (HD) in Santa Maria-RS.

Detailed description

C-reactive protein (CRP) has been identified as a possible mediator of the association between periodontitis and various systemic diseases. The presence of periodontitis has been hypothesized as a risk factor for several systemic outcomes, including chronic kidney disease (CKD). Therefore, the aim of this study is to evaluate the impact of non-surgical periodontal treatment on CRP levels and quality of life of patients with chronic kidney disease undergoing hemodialysis (HD) in Santa Maria-RS. A total of 88 patients with severe periodontitis who are on HD therapy will be included in this study. At baseline, periodontal, radiographic, blood test, and quality-of-life questionnaire will be assessed for all patients, after which severe periodontitis will be defined according to the American Association of Periodontology and European Federation of Periodontology. The 88 patients with periodontal disease will be randomized and divided into two groups. One group will receive full mouth non-surgical periodontal treatment (TPNC) and a late treatment group that will receive TPNC only at the end of the study. All patients will receive follow-up of periodontal parameters and blood collection for initial CRP assessment at 3 and 6 months after treatment. Outcome evaluators will be blind to the group the patient belongs to. Patients in the immediate treatment group will receive follow-up oral hygiene instructions and use 0.12% chlorhexidine mouthwash during the first week after treatment.

Conditions

• Chronic Kidney Disease Stage 5
• Periodontitis

Interventions

Type	Name	Description
PROCEDURE	immediate treatment	Patients allocated to the immediate treatment group will receive full mouth treatment, and will use 0.12% chlorhexidine mouthwash, every 12 hours for a week, and will receive oral hygiene instructions throughout the follow-up period. Patients will be evaluated at the beginning, at 3 and 6 months.
PROCEDURE	postponed treatment	Patients allocated to the late treatment group will be assessed at baseline, 3 and 6 months. After the end of the follow-up period, they will receive non-surgical periodontal treatment performed in four sessions.

Timeline

• Start date: 2020-02-29
• Primary completion: 2020-11-01
• Completion: 2021-06-01
• First posted: 2020-02-10
• Last updated: 2020-02-20

Locations

1 site across 1 country: Brazil