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

Periodontitis Clinical Trial

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT04262011
• Other study ID #: 10453519.4.0000.5346
• Status: Not yet recruiting
• Phase: N/A
• Start date: February 29, 2020
• Est. completion date: June 1, 2021

Study information

• Verified date: February 2020
• Source: Universidade Federal de Santa Maria
• Contact: Fabricio B Zanatta, pHD
• Phone: +555581283358
• Email: fabriciobzanatta[@]gmail.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 88
• Est. completion date: June 1, 2021
• Est. primary completion date: November 1, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 90 Years

Eligibility

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;

Related Conditions & MeSH terms

• Chronic Kidney Disease Stage 5
• Kidney Diseases
• Periodontitis
• Renal Insufficiency, Chronic

Intervention

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.
• 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.

Locations

Country	Name	City	State
Brazil	Fabricio Batistin Zanatta	Santa Maria	Rua Floriano Peixoto--

Sponsors (1)

Lead Sponsor	Collaborator
Universidade Federal de Santa Maria

Country where clinical trial is conducted

Brazil, 

References & 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. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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.	baseline changes by 6 months follow-up
Secondary	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.	baseline changes by 6 months follow-up
Secondary	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.	baseline changes by 6 months follow-up
Secondary	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.	baseline changes by 6 months follow-up
Secondary	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.	baseline changes by 6 months follow-up