An interventional study of immediate treatment and postponed treatment in Chronic Kidney Disease Stage 5 and Periodontitis, sponsored by Universidade Federal de Santa Maria. Status unknown at 1 site in Brazil. Open to participants aged 18 Years to 90 Years. Per ClinicalTrials.gov, last updated 2020-02-20.
Sponsored by Universidade Federal de Santa Maria · Not applicable, Interventional, and Treatment
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.
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.
1,635 studies on the registry are indexed under Periodontitis; 327 are open to participants now.
This study's planned enrollment of 88 is above the median of 45 across 1,191 interventional studies indexed under Periodontitis.
Browse Periodontitis studies →Universidade Federal de Santa Maria is the lead sponsor of 36 studies on the registry; 2 are open to participants now.
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Minimum Age: 18 Years Sex: All Accepts Healthy Volunteers: No
Criteria:
Inclusion Criteria:
Exclusion Criteria:
Ineligible individuals were characterized by exhibiting one of the following conditions:
After randomization, patients who are allocated to the immediate treatment group will receive treatment.
Procedure: immediate 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 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.
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.
Time frame: baseline changes by 6 months follow-up
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.
Time frame: baseline changes by 6 months follow-up
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.
Time frame: baseline changes by 6 months follow-up
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.
Time frame: baseline changes by 6 months follow-up
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.
Time frame: baseline changes by 6 months follow-up
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.
Time frame: baseline changes by 6 months follow-up
Plan to share: No
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Universidade Federal de Santa Maria