Chronic Kidney Disease Stage 5NCT04262011
Effect of Non-surgical Periodontal Treatment and C-reactive Protein Levels in Hemodialysis Patients
A study testing immediate treatment and postponed treatment in people with Chronic Kidney Disease Stage 5 and Periodontitis, run by Universidade Federal de Santa Maria at 1 site in Brazil.
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… Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Chronic Kidney Disease Stage 5, Periodontitis
- What is being tested?
- immediate treatment and postponed treatment
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteBrazil
- Study dates
- 29 Feb 2020to 1 Jun 2021
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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;
Trial locations and contacts
1 site in 1 country.
Brazil1 site
Fabricio Batistin Zanatta
Santa Maria, Rua Floriano Peixoto--, 97015-372
About this study
Official title: Effect of Non-surgical Periodontal Treatment on Renal Function and C-reactive Protein Levels in Hemodialysis Patients
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.
Read the 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.
- Conditions
- Chronic Kidney Disease Stage 5, Periodontitis
- Being tested
- immediate treatment, postponed treatment
- Keywords
- chronic kidney disease, hemodialysis, periodontal diseases, periodontitis
- Medical subject headings
- Renal Insufficiency, Chronic, Periodontitis, Periodontal Diseases
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
immediate treatmentProcedure or surgery
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 treatmentProcedure or surgery
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.
| Study group | Role | What they receive |
|---|---|---|
| immediate treatment | Other | After randomization, patients who are allocated to the immediate treatment group will receive treatment. Receives: Procedure: immediate treatment |
| postponed treatment | Other | After randomized patients will be allocated to this group, they will wait for the follow-up of the study to receive delayed treatment. Receives: Procedure: postponed treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: baseline changes by 6 months follow-up
Secondary outcomes (5)
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.
Measured: 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.
Measured: baseline changes by 6 months follow-up
effect of periodontal treatment on overall quality of life and related to kidney disease
- 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.
Measured: 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.
Measured: 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.
Measured: baseline changes by 6 months follow-up
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Feb 2020
- Study start29 Feb 2020 (estimated)
- Primary completion1 Nov 2020 (estimated)
- Study completion1 Jun 2021 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney Disease Stage 5Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- The study will have two groups, one receiving immediate periodontal treatment and the other receiving late periodontal treatment.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 88 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Universidade Federal de Santa Maria
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fabricio Batistin Zanatta, Universidade Federal de Santa Maria
- Investigators
- Raquel P Antoniazzi, pHD, Study director, Universidade Federal de Santa MariaSamantha S Santi, DS, Study chair, Universidade Federal de Santa MariaLeandro M Oliveira, MS, Study chair, Universidade Federal de Santa MariaRafaela V Palmeira, MS, Study chair, Universidade Federal de Santa MariaCatiusse C Del'Agnese, MS, Study chair, Universidade Federal de Santa Maria
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04262011
- Sponsor's protocol ID
- 10453519.4.0000.5346
- Status last verified
- Feb 2020
- First submitted
- 17 Dec 2019
- Last updated
- 20 Feb 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 25933364
Study at a glance
From the registry record, last updated by the sponsor on 20 Feb 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Non-surgical Periodontal Treatment on Renal Function and C-reactive Protein Levels in Hemodialysis Patients
- ClinicalTrials.gov ID
- NCT04262011
- Acronym / sponsor ID
- 10453519.4.0000.5346
- Conditions
- Chronic Kidney Disease Stage 5, Periodontitis
- Keywords
- chronic kidney disease, hemodialysis, periodontal diseases, periodontitis
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 88 participants (estimated)
- Lead sponsor
- Universidade Federal de Santa MariaUniversity, hospital or other
- Study start
- 29 Feb 2020 (estimated)
- Primary completion
- 1 Nov 2020 (estimated)
- Study completion
- 1 Jun 2021 (estimated)
- First posted
- 10 Feb 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- The study will have two groups, one receiving immediate periodontal treatment and the other receiving late periodontal treatment.
| Arm | Type | Receives |
|---|---|---|
| immediate treatment | Other | Procedure: immediate treatmentAfter randomization, patients who are allocated to the immediate treatment group will receive treatment. |
| postponed treatment | Other | Procedure: postponed treatmentAfter randomized patients will be allocated to this group, they will wait for the follow-up of the study to receive delayed treatment. |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- 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.
Key exclusion criteria (8 listed)
- 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;
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| immediate treatmentPatients 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. | Procedure or surgery | immediate treatment |
| postponed treatmentPatients 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. | Procedure or surgery | postponed treatment |
Primary outcome
effect of periodontal treatment on levels of systemic inflammatory markers
Time frame: baseline changes by 6 months follow-up
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.
5 secondary outcomes
effect of periodontal treatment on oral health-related quality of life
Time frame: baseline changes by 6 months follow-up
effect of periodontal treatment on overall quality of life
Time frame: baseline changes by 6 months follow-up
effect of periodontal treatment on overall quality of life and related to kidney disease
Time frame: baseline changes by 6 months follow-up
effect of periodontal treatment on psychological condition in patients with chronic kidney disease undergoing hemodialysis
Time frame: baseline changes by 6 months follow-up
effect of periodontal treatment on psychological condition
Time frame: baseline changes by 6 months follow-up
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Feb 2020.
- Background: PubMed 25933364Fang 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raquel P Antoniazzi, pHD study director
Universidade Federal de Santa Maria
Samantha S Santi, DS study chair
Universidade Federal de Santa Maria
Leandro M Oliveira, MS study chair
Universidade Federal de Santa Maria
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing immediate treatment and postponed treatment in people with Chronic Kidney Disease Stage 5 and Periodontitis, run by Universidade Federal de Santa Maria at 1 site in Brazil.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 20 Feb 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Brazil. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Fabricio B Zanatta, pHD (+555581283358, fabriciobzanatta@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
effect of periodontal treatment on levels of systemic inflammatory markers (time frame: baseline changes by 6 months follow-up). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04262011, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Feb 2020.