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

Universidade Federal de Santa Maria

Status: Unknown

Conditions: Periodontitis; Chronic Kidney Disease Stage 5

Treatments: Procedure: postponed treatment; Procedure: immediate treatment

Study type: Interventional

Funder types: Other

Identifiers

NCT04262011

10453519.4.0000.5346

Details and patient eligibility

About

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.

Full 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.

Enrollment: 88 estimated patients

Sex: All

Ages: 18 to 90 years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion criteria

Minimum Age: 18 Years Sex: All Accepts Healthy Volunteers: No

Criteria:

Inclusion Criteria:

• Having been diagnosed with chronic kidney disease (CKD) for at least 90 days.
• Have at least 8 teeth in the mouth.
• For the patient to be classified as having periodontal disease, he must have at least two nonadjacent sites with insertion loss of 3mm or more and two nonadjacent sites with probing depth of 4mm or more.

Exclusion Criteria:

Ineligible individuals were characterized by exhibiting one of the following conditions:

• Patients diagnosed with malignant neoplasia;
• Patients diagnosed with carriers of the HIV virus;
• Pregnant or lactating women;
• Patients with absence of all dental elements (total edentulous);
• Patients undergoing orthodontic treatment;
• Patients who have received periodontal treatment in the last 6 months.
• Patients with active infection (other than periodontitis) who require antibiotic prophylaxis;

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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88 participants in 2 patient groups

immediate treatment

Other group

Description:

After randomization, patients who are allocated to the immediate treatment group will receive treatment.

Treatment:

Procedure: immediate treatment

postponed treatment

Other group

Description:

After randomized patients will be allocated to this group, they will wait for the follow-up of the study to receive delayed treatment.

Treatment:

Procedure: postponed treatment