Clinical trial NCT04262011: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Chronic Kidney Disease Stage 5
Periodontitis
Keywords: chronic kidney disease
hemodialysis
periodontal diseases
periodontitis
Lead sponsor: Universidade Federal de Santa Maria
Sponsor class: OTHER
First posted: 2020-02-10
Enrollment: 88
Sex: ALL
Minimum age (years): 18
Maximum age (years): 90
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: The study will have two groups, one receiving immediate periodontal treatment and the other receiving late periodontal treatment.
Primary purpose: TREATMENT

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.

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;

Primary outcomes:
measure: effect of periodontal treatment on levels of systemic inflammatory markers
timeFrame: baseline changes by 6 months follow-up
Secondary outcomes:
measure: effect of periodontal treatment on oral health-related quality of life
timeFrame: baseline changes by 6 months follow-up
measure: effect of periodontal treatment on overall quality of life
timeFrame: baseline changes by 6 months follow-up
measure: effect of periodontal treatment on overall quality of life and related to kidney disease
timeFrame: baseline changes by 6 months follow-up
measure: effect of periodontal treatment on psychological condition in patients with chronic kidney disease undergoing hemodialysis
timeFrame: baseline changes by 6 months follow-up
measure: effect of periodontal treatment on psychological condition
timeFrame: baseline changes by 6 months follow-up
Other outcomes:
Locations:
city: Santa Maria
country: Brazil
facility: Fabricio Batistin Zanatta
state: Rua Floriano Peixoto--
Study officials:
affiliation: Universidade Federal de Santa Maria
name: Raquel P Antoniazzi, pHD
role: STUDY_DIRECTOR
affiliation: Universidade Federal de Santa Maria
name: Samantha S Santi, DS
role: STUDY_CHAIR
affiliation: Universidade Federal de Santa Maria
name: Leandro M Oliveira, MS
role: STUDY_CHAIR
affiliation: Universidade Federal de Santa Maria
name: Rafaela V Palmeira, MS
role: STUDY_CHAIR
affiliation: Universidade Federal de Santa Maria
name: Catiusse C Del'Agnese, MS
role: STUDY_CHAIR
References:
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.