Effect of Non-surgical Periodontal Treatment and C-reactive Protein Levels in Hemodialysis Patients
1 other identifier
interventional
88
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P50-P75 for not_applicable
Started Feb 2020
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 17, 2019
CompletedFirst Posted
Study publicly available on registry
February 10, 2020
CompletedStudy Start
First participant enrolled
February 29, 2020
CompletedPrimary Completion
Last participant's last visit for primary outcome
November 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2021
CompletedFebruary 20, 2020
February 1, 2020
8 months
December 17, 2019
February 18, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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.
baseline changes by 6 months follow-up
Secondary Outcomes (5)
effect of periodontal treatment on oral health-related quality of life
baseline changes by 6 months follow-up
effect of periodontal treatment on overall quality of life
baseline changes by 6 months follow-up
effect of periodontal treatment on overall quality of life and related to kidney disease
baseline changes by 6 months follow-up
effect of periodontal treatment on psychological condition in patients with chronic kidney disease undergoing hemodialysis
baseline changes by 6 months follow-up
effect of periodontal treatment on psychological condition
baseline changes by 6 months follow-up
Study Arms (2)
immediate treatment
OTHERAfter randomization, patients who are allocated to the immediate treatment group will receive treatment.
postponed treatment
OTHERAfter randomized patients will be allocated to this group, they will wait for the follow-up of the study to receive delayed treatment.
Interventions
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.
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.
Eligibility Criteria
You may qualify if:
- 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.
You may not qualify if:
- 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;
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Fabricio Batistin Zanatta
Santa Maria, Rua Floriano Peixoto--, 97015-372, Brazil
Related Publications (1)
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.
PMID: 25933364BACKGROUND
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- 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
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- RANDOMIZED
- Masking
- SINGLE
- Who Masked
- OUTCOMES ASSESSOR
- Masking Details
- Outcome assessors will be blind to the group to which the patient belongs, whether immediate or late.
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Principal advisor
Study Record Dates
First Submitted
December 17, 2019
First Posted
February 10, 2020
Study Start
February 29, 2020
Primary Completion
November 1, 2020
Study Completion
June 1, 2021
Last Updated
February 20, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share