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

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

88 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-02-29

Study Completion Date

2021-06-01

Brief Summary

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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.

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Detailed Description

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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

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Chronic Kidney Disease Stage 5 Periodontitis

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

The study will have two groups, one receiving immediate periodontal treatment and the other receiving late periodontal treatment.

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Outcome Assessors

Outcome assessors will be blind to the group to which the patient belongs, whether immediate or late.

Study Groups

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immediate treatment

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

Group Type OTHER

immediate treatment

Intervention Type PROCEDURE

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.

postponed treatment

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

Group Type OTHER

postponed treatment

Intervention Type PROCEDURE

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.

Interventions

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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.

Intervention Type 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.

Intervention Type PROCEDURE

Eligibility Criteria

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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;

Minimum Eligible Age

18 Years

Maximum Eligible Age

90 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No