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

February 18, 2020 updated by: Fabricio Batistin Zanatta, Universidade Federal de Santa Maria

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

Study Type

Interventional

Enrollment (Anticipated)

88

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

Study Locations

  • Brazil
    • Rua Floriano Peixoto--
      • Santa Maria, Rua Floriano Peixoto--, Brazil, 97015-372
        • Fabricio Batistin Zanatta

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 90 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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;

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Other: immediate treatment
After randomization, patients who are allocated to the immediate treatment group will receive treatment.
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.
Other: 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.
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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect of periodontal treatment on levels of systemic inflammatory markers
Time Frame: baseline changes by 6 months follow-up
To evaluate the impacts of periodontal treatment on the levels of systemic inflammatory markers such as C-reactive protein, albumin and transferrin saturation. The patients will be submitted to the collection of blood sample in the baseline, 3 and 6 months to obtain the clinical variables.
baseline changes by 6 months follow-up

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
effect of periodontal treatment on oral health-related quality of life
Time Frame: baseline changes by 6 months follow-up
To assess the impacts of periodontal treatment on overall quality of life and oral health that will be assessed using the questionnaire Oral Health Impact Profile (OHIP14) (14 items), in this questionnaire the higher the score, the worse the quality of life is considered.
baseline changes by 6 months follow-up
effect of periodontal treatment on overall quality of life
Time Frame: baseline changes by 6 months follow-up
To assess the impacts of periodontal treatment on overall quality of life and oral health that will be assessed using the questionnaire The Short-Form Health Survey (SF-36) (36 items). In this questionnaires, the higher the score, the worse the quality of life is considered.
baseline changes by 6 months follow-up
effect of periodontal treatment on overall quality of life and related to kidney disease
Time Frame: baseline changes by 6 months follow-up
o assess the impacts of periodontal treatment on overall quality of life and oral health that will be assessed using the questionnaire Kidney Disease Quality of Life Short Form (KDQOL-SF) (80 items). This scale ranges from 0 to 100, higher values show a better quality of life.
baseline changes by 6 months follow-up
effect of periodontal treatment on psychological condition in patients with chronic kidney disease undergoing hemodialysis
Time Frame: baseline changes by 6 months follow-up
ndividuals' psychological condition will be assessed using the Depression - Anxiety - Stress Scale 21 (DASS 21) (21 items).The highest grades in each scale correspond to more negative affective states.
baseline changes by 6 months follow-up
effect of periodontal treatment on psychological condition
Time Frame: baseline changes by 6 months follow-up
Individuals' psychological condition will be assessed using the sense of coherence (SOC 13) which proposes to explain successful strategies to cope with stress. For the final score calculation, the items are summed and the result can vary from 13 to 65, where higher scores represent SOC. The the greater the result, the greater the coping capacity.
baseline changes by 6 months follow-up

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Universidade Federal de Santa Maria

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Anticipated)

February 29, 2020

Primary Completion (Anticipated)

November 1, 2020

Study Completion (Anticipated)

June 1, 2021

Study Registration Dates

First Submitted

December 17, 2019

First Submitted That Met QC Criteria

February 5, 2020

First Posted (Actual)

February 10, 2020

Study Record Updates

Last Update Posted (Actual)

February 20, 2020

Last Update Submitted That Met QC Criteria

February 18, 2020

Last Verified

February 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 10453519.4.0000.5346

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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