Effect of Non-surgical Periodontal Treatment and C-reactive Protein Levels in Hemodialysis Patients
Primary Purpose
Chronic Kidney Disease Stage 5, Periodontitis
Status
Unknown status
Phase
Not Applicable
Locations
Brazil
Study Type
Interventional
Intervention
immediate treatment
postponed treatment
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease Stage 5 focused on measuring chronic kidney disease, hemodialysis, periodontal diseases, periodontitis
Eligibility 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;
Sites / Locations
- Fabricio Batistin Zanatta
Arms of the Study
Arm 1
Arm 2
Arm Type
Other
Other
Arm Label
immediate treatment
postponed treatment
Arm Description
After randomization, patients who are allocated to the immediate treatment group will receive treatment.
After randomized patients will be allocated to this group, they will wait for the follow-up of the study to receive delayed treatment.
Outcomes
Primary Outcome Measures
effect of periodontal treatment on levels of systemic inflammatory markers
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.
Secondary Outcome Measures
effect of periodontal treatment on oral health-related quality of life
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.
effect of periodontal treatment on overall quality of life
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.
effect of periodontal treatment on overall quality of life and related to kidney disease
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.
effect of periodontal treatment on psychological condition in patients with chronic kidney disease undergoing hemodialysis
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.
effect of periodontal treatment on psychological condition
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.
Full Information
NCT ID
NCT04262011
First Posted
December 17, 2019
Last Updated
February 18, 2020
Sponsor
Universidade Federal de Santa Maria
1. Study Identification
Unique Protocol Identification Number
NCT04262011
Brief Title
Effect of Non-surgical Periodontal Treatment and C-reactive Protein Levels in Hemodialysis Patients
Official Title
Effect of Non-surgical Periodontal Treatment on Renal Function and C-reactive Protein Levels in Hemodialysis Patients
Study Type
Interventional
2. Study Status
Record Verification Date
February 2020
Overall Recruitment Status
Unknown status
Study Start Date
February 29, 2020 (Anticipated)
Primary Completion Date
November 1, 2020 (Anticipated)
Study Completion Date
June 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Universidade Federal de Santa Maria
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
Yes
5. Study Description
Brief 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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease Stage 5, Periodontitis
Keywords
chronic kidney disease, hemodialysis, periodontal diseases, periodontitis
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
The study will have two groups, one receiving immediate periodontal treatment and the other receiving late periodontal treatment.
Masking
Outcomes Assessor
Masking Description
Outcome assessors will be blind to the group to which the patient belongs, whether immediate or late.
Allocation
Randomized
Enrollment
88 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
immediate treatment
Arm Type
Other
Arm Description
After randomization, patients who are allocated to the immediate treatment group will receive treatment.
Arm Title
postponed treatment
Arm Type
Other
Arm Description
After randomized patients will be allocated to this group, they will wait for the follow-up of the study to receive delayed treatment.
Intervention Type
Procedure
Intervention Name(s)
immediate treatment
Intervention Description
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
Intervention Name(s)
postponed treatment
Intervention Description
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.
Primary Outcome Measure Information:
Title
effect of periodontal treatment on levels of systemic inflammatory markers
Description
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.
Time Frame
baseline changes by 6 months follow-up
Secondary Outcome Measure Information:
Title
effect of periodontal treatment on oral health-related quality of life
Description
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.
Time Frame
baseline changes by 6 months follow-up
Title
effect of periodontal treatment on overall quality of life
Description
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.
Time Frame
baseline changes by 6 months follow-up
Title
effect of periodontal treatment on overall quality of life and related to kidney disease
Description
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.
Time Frame
baseline changes by 6 months follow-up
Title
effect of periodontal treatment on psychological condition in patients with chronic kidney disease undergoing hemodialysis
Description
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.
Time Frame
baseline changes by 6 months follow-up
Title
effect of periodontal treatment on psychological condition
Description
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.
Time Frame
baseline changes by 6 months follow-up
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
90 Years
Accepts Healthy Volunteers
No
Eligibility 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;
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Fabricio B Zanatta, pHD
Phone
+555581283358
Email
fabriciobzanatta@gmail.com
First Name & Middle Initial & Last Name or Official Title & Degree
Caroline Schoffer, DS
Phone
+5555999346017
Email
schoffercaroline@gmail.com
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raquel P Antoniazzi, pHD
Organizational Affiliation
Universidade Federal de Santa Maria
Official's Role
Study Director
First Name & Middle Initial & Last Name & Degree
Samantha S Santi, DS
Organizational Affiliation
Universidade Federal de Santa Maria
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Leandro M Oliveira, MS
Organizational Affiliation
Universidade Federal de Santa Maria
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Rafaela V Palmeira, MS
Organizational Affiliation
Universidade Federal de Santa Maria
Official's Role
Study Chair
First Name & Middle Initial & Last Name & Degree
Catiusse C Del'Agnese, MS
Organizational Affiliation
Universidade Federal de Santa Maria
Official's Role
Study Chair
Facility Information:
Facility Name
Fabricio Batistin Zanatta
City
Santa Maria
State/Province
Rua Floriano Peixoto--
ZIP/Postal Code
97015-372
Country
Brazil
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
PubMed Identifier
25933364
Citation
Fang F, Wu B, Qu Q, Gao J, Yan W, Huang X, Ma D, Yue J, Chen T, Liu F, Liu Y. The clinical response and systemic effects of non-surgical periodontal therapy in end-stage renal disease patients: a 6-month randomized controlled clinical trial. J Clin Periodontol. 2015 Jun;42(6):537-46. doi: 10.1111/jcpe.12411. Epub 2015 May 30.
Results Reference
background
Learn more about this trial
Effect of Non-surgical Periodontal Treatment and C-reactive Protein Levels in Hemodialysis Patients
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