Recruitment

Recruitment Status
Not yet recruiting
Estimated Enrollment
Same as current

Summary

Conditions
  • Chronic Kidney Disease Stage 5
  • Periodontitis
Type
Interventional
Phase
Not Applicable
Design
Allocation: RandomizedIntervention Model: Parallel AssignmentIntervention Model Description: The study will have two groups, one receiving immediate periodontal treatment and the other receiving late periodontal treatment.Masking: Single (Outcomes Assessor)Masking Description: Outcome assessors will be blind to the group to which the patient belongs, whether immediate or late.Primary Purpose: Treatment

Participation Requirements

Age
Between 18 years and 90 years
Gender
Both males and females

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 o...

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.

Tracking Information

NCT #
NCT04262011
Collaborators
Not Provided
Investigators
Study Director: Raquel P Antoniazzi, pHD Universidade Federal de Santa Maria Study Chair: Samantha S Santi, DS Universidade Federal de Santa Maria Study Chair: Leandro M Oliveira, MS Universidade Federal de Santa Maria Study Chair: Rafaela V Palmeira, MS Universidade Federal de Santa Maria Study Chair: Catiusse C Del'Agnese, MS Universidade Federal de Santa Maria