Mouth DiseasesNCT02357199
Interventional Study Targeting Oral Infections in Patients With Chronic Kidney Disease
A study testing Intensive oral care & didactic training in people with Mouth Diseases and Renal Insufficiency, Chronic, run by University of Copenhagen at 1 site in Denmark.
Trial summary
This study aims to investigate the prevalence of oral infection in chronic renal disease patients and to examine whether a focused oral hygiene intervention can reduce oral infection leading to reduced systemic inflammatory parameters in chronic renal disease patients in hemodialysis, chronic renal disease patients… Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Mouth Diseases, Renal Insufficiency, Chronic
- What is being tested?
- Intensive oral care & didactic training
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 93 participants
- Where
- 1 siteDenmark
- Study dates
- Jan 2015to Aug 2015
- 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients on a kidney transplant waiting list or patients who have had a kidney transplant (1-1½ year previously)
- Dentate patients (>10 teeth)
- Age >18 years
- Danish language
Who cannot join
- Patients not capable of following the research protocol
- Legally unavailable
- Need of antibiotic prophylaxis with dental treatment
- Heart valve surgery
Trial locations and contacts
1 site in 1 country.
Denmark1 site
Department of Odontology, Faculty of Health Sciences, University of Copenhagen
Copenhagen, DK-2200
About this study
This study aims to investigate the prevalence of oral infection in chronic renal disease patients and to examine whether a focused oral hygiene intervention can reduce oral infection leading to reduced systemic inflammatory parameters in chronic renal disease patients in hemodialysis, chronic renal disease patients waiting for kidney transplantation, and chronic renal disease patients who has been transplanted 1-1½ year previously. The results will be compared to a gender- and age-matched healthy control group.
Read the detailed description
Aim:
The aim is to examine if a focused oral care procedure to reduce oral infection will be mirrored in reduction of systemic inflammatory parameters in chronic renal disease patients.
Specific research questions:
Can oral infection and systemic inflammatory parameters in chronic renal disease patients be reduced by 1 month of professional oral care and individual prophylactic instruction and can a potential reduction of inflammation be continuously achieved at a 3 months follow-up.
Study design:
Randomized, double-blinded (investigator, outcomes assessor), controlled study. For Eligibility Criteria and Outcome Measures, please see elsewhere in the ClinicalTrials.gov Protocol Registration System.
Participants:
A: Hemodialysis patients, inclusion n=34, B: Hemodialysis patients on a kidney transplant waiting list, inclusion n=34, C: Patients who have had a kidney transplant (1-1½ years after transplantation), inclusion n=34. D: Gender- and age-matched healthy control group.
Number of included patients is estimated from a hypothesis-generating pilot study, a statistical power analysis and the estimated loss to follow-up based on experience from previous research projects in the Nephrology Department.
Intervention and control:
The intervention consists of professional oral care (addressing periodontal and oral mucosal infections, salivary gland dysfunction and caries prevention) and a didactic approach to individual instruction in oral hygiene/prophylactic measures performed by a dental hygienist at three visits: baseline, 2 weeks after baseline and 1 month after baseline.
The research data will be registered by a blinded investigator before the first visit at the dental hygienist and after 3 months.
The control group will follow best-clinical-practice procedures currently implemented in the hospital.
- Conditions
- Mouth Diseases, Renal Insufficiency, Chronic
- Being tested
- Intensive oral care & didactic training
- Keywords
- Mouth Diseases, Renal Insufficiency, Chronic, Intervention Studies
- Medical subject headings
- Mouth Diseases, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Intensive oral care & didactic trainingOther
Professional (dental hygienist) intensive oral care intervention and individual patient training/didactic instruction to promote patient compliance and patient capability of oral preventive measures in a long-term perspective.
| Study group | Role | What they receive |
|---|---|---|
| Intensive oral care & didactic training | Experimental | Professional (dental hygienist) intensive oral care intervention and individual patient training/didactic instruction to promote patient compliance and patient capability of oral preventive measures in a long-term perspective. Receives: Other: Intensive oral care & didactic training |
| Standard oral care | No intervention | Standard oral care protocol consisting of referral by staff in the Department of Nephrology to general dental practitioner followed by patient self-administration of tooth brushing, fluoride toothpaste and oral lubricants. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Gingival inflammation
Gingival inflammation measured by gingivitis index
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
C-reactive protein, plasma
Blood sample
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Secondary outcomes (30)
Dental bacterial plaque
Measured by plaque index
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Periodontal disease
Measurement of attachment level
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Whole saliva flow rate, unstimulated
Sialometry
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Whole saliva flow rate, stimulated
Sialometry
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Sodium
Sialochemistry
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Chloride
Sialochemistry
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Potassium
Sialochemistry
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Total calcium
Sialochemistry
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Inorganic phosphate
Sialochemistry
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Total protein
Sialochemistry
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Albumin
Sialochemistry
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Amylase activity
Sialochemistry
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Secretory IgA
Sialochemistry
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Oral candidiasis
Smear test
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Hematologic status: Erythrocytes
Blood sample
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Hematologic status: Hemoglobin
Blood sample
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Hematologic status: Leukocytes
Blood sample
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Hematologic status: Thrombocytes
Blood sample
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Hematologic status: Transferrin
Blood sample
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Hematologic status: Iron
Blood sample
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Calcium metabolism
Blood sample
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Phosphate metabolism
Blood sample
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Renal function: Carbamide
Blood sample
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Renal function: Bicarbonate
Blood sample
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Renal function: Creatinine
Blood sample
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Renal function: Albumin
Blood sample
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Renal function: Potassium
Blood sample
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Renal function: Sodium
Blood sample
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Oral Health Impact Profile
Quality of life questionnaire
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Medical Outcomes Study Short Version
Quality of life questionnaire
Measured: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Feb 2015 (estimated)
- Study startJan 2015
- Primary completionAug 2015
- Study completionAug 2015
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Mouth DiseasesStudies of the same condition, open and under way.
- More trials run by University of CopenhagenThe sponsor's other registered studies.
- 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Investigator, Outcomes assessor
- Enrolment
- 93 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Copenhagen
- Sponsor type
- University, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Danish Council for Independent Research - Medical Sciences, The Danish Dental Association
- Responsible party
- Principal investigator, Siri Beier Jensen, University of Copenhagen
- Investigators
- Siri B Jensen, DDS, PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02357199
- Sponsor's protocol ID
- 102-2084/14-3000
- Status last verified
- Aug 2015
- First submitted
- 28 Jan 2015
- Last updated
- 31 Aug 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Kato S, Chmielewski M, Honda H, Pecoits-Filho R, Matsuo S, Yuzawa Y, Tranaeus A, Stenvinkel P, Lindholm B. Aspects of immune dysfunction in end-stage renal disease. Clin J Am Soc Nephrol. 2008 Sep;3(5):1526-33. doi: 10.2215/CJN.00950208. Epub 2008 Aug 13.
PubMed 18701615McIntyre C, Harper I, Macdougall IC, Raine AE, Williams A, Baker LR. Serum C-reactive protein as a marker for infection and inflammation in regular dialysis patients. Clin Nephrol. 1997 Dec;48(6):371-4.
PubMed 9438096Thorman R. Oral health in patients with chronic kidney disease. Stockholm, Sweden: Karolinska Institutet; 2009
Study at a glance
From the registry record, last updated by the sponsor on 31 Aug 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Interventional Study Targeting Oral Infections in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02357199
- Acronym / sponsor ID
- 102-2084/14-3000
- Conditions
- Mouth Diseases, Renal Insufficiency, Chronic
- Keywords
- Mouth Diseases, Renal Insufficiency, Chronic, Intervention Studies
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 93 participants (actual)
- Lead sponsor
- University of CopenhagenUniversity, hospital or other
- Collaborators
- Copenhagen University Hospital, Rigshospitalet, Danish Council for Independent Research - Medical Sciences, The Danish Dental Association
- Study start
- Jan 2015
- Primary completion
- Aug 2015 (actual)
- Study completion
- Aug 2015 (actual)
- First posted
- 6 Feb 2015 (estimated)
- 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.
This study aims to investigate the prevalence of oral infection in chronic renal disease patients and to examine whether a focused oral hygiene intervention can reduce oral infection leading to reduced systemic inflammatory parameters in chronic renal disease patients in hemodialysis, chronic renal disease patients waiting for kidney transplantation, and chronic renal disease patients who has been transplanted 1-1½ year previously. The results will be compared to a gender- and age-matched healthy control group.
Detailed description
Aim:
The aim is to examine if a focused oral care procedure to reduce oral infection will be mirrored in reduction of systemic inflammatory parameters in chronic renal disease patients.
Specific research questions:
Can oral infection and systemic inflammatory parameters in chronic renal disease patients be reduced by 1 month of professional oral care and individual prophylactic instruction and can a potential reduction of inflammation be continuously achieved at a 3 months follow-up.
Study design:
Randomized, double-blinded (investigator, outcomes assessor), controlled study. For Eligibility Criteria and Outcome Measures, please see elsewhere in the ClinicalTrials.gov Protocol Registration System.
Participants:
A: Hemodialysis patients, inclusion n=34, B: Hemodialysis patients on a kidney transplant waiting list, inclusion n=34, C: Patients who have had a kidney transplant (1-1½ years after transplantation), inclusion n=34. D: Gender- and age-matched healthy control group.
Number of included patients is estimated from a hypothesis-generating pilot study, a statistical power analysis and the estimated loss to follow-up based on experience from previous research projects in the Nephrology Department.
Intervention and control:
The intervention consists of professional oral care (addressing periodontal and oral mucosal infections, salivary gland dysfunction and caries prevention) and a didactic approach to individual instruction in oral hygiene/prophylactic measures performed by a dental hygienist at three visits: baseline, 2 weeks after baseline and 1 month after baseline.
The research data will be registered by a blinded investigator before the first visit at the dental hygienist and after 3 months.
The control group will follow best-clinical-practice procedures currently implemented in the hospital.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intensive oral care & didactic training | Experimental | Other: Intensive oral care & didactic trainingProfessional (dental hygienist) intensive oral care intervention and individual patient training/didactic instruction to promote patient compliance and patient capability of oral preventive measures in a long-term perspective. |
| Standard oral care | No intervention | –Standard oral care protocol consisting of referral by staff in the Department of Nephrology to general dental practitioner followed by patient self-administration of tooth brushing, fluoride toothpaste and oral lubricants. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients on a kidney transplant waiting list or patients who have had a kidney transplant (1-1½ year previously)
- Dentate patients (>10 teeth)
- Age >18 years
- Danish language
Key exclusion criteria (4 listed)
- Patients not capable of following the research protocol
- Legally unavailable
- Need of antibiotic prophylaxis with dental treatment
- Heart valve surgery
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 |
|---|---|---|
| Intensive oral care & didactic trainingProfessional (dental hygienist) intensive oral care intervention and individual patient training/didactic instruction to promote patient compliance and patient capability of oral preventive measures in a long-term perspective. | Other | Intensive oral care & didactic training |
Primary outcome
Gingival inflammation
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Gingival inflammation measured by gingivitis index
C-reactive protein, plasma
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Blood sample
30 secondary outcomes
Dental bacterial plaque
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Periodontal disease
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Whole saliva flow rate, unstimulated
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Whole saliva flow rate, stimulated
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Sodium
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Chloride
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Potassium
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Total calcium
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Inorganic phosphate
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Total protein
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Albumin
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Amylase activity
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Saliva composition: Secretory IgA
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Oral candidiasis
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Hematologic status: Erythrocytes
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Hematologic status: Hemoglobin
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Hematologic status: Leukocytes
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Hematologic status: Thrombocytes
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Hematologic status: Transferrin
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Hematologic status: Iron
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Calcium metabolism
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Phosphate metabolism
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Renal function: Carbamide
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Renal function: Bicarbonate
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Renal function: Creatinine
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Renal function: Albumin
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Renal function: Potassium
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Renal function: Sodium
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Oral Health Impact Profile
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Medical Outcomes Study Short Version
Time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Aug 2015.
- Background: PubMed 18701615Kato S, Chmielewski M, Honda H, Pecoits-Filho R, Matsuo S, Yuzawa Y, Tranaeus A, Stenvinkel P, Lindholm B. Aspects of immune dysfunction in end-stage renal disease. Clin J Am Soc Nephrol. 2008 Sep;3(5):1526-33. doi: 10.2215/CJN.00950208. Epub 2008 Aug 13.
- Background: PubMed 9438096McIntyre C, Harper I, Macdougall IC, Raine AE, Williams A, Baker LR. Serum C-reactive protein as a marker for infection and inflammation in regular dialysis patients. Clin Nephrol. 1997 Dec;48(6):371-4.
- BackgroundThorman R. Oral health in patients with chronic kidney disease. Stockholm, Sweden: Karolinska Institutet; 2009
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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.
Siri B Jensen, DDS, PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Intensive oral care & didactic training in people with Mouth Diseases and Renal Insufficiency, Chronic, run by University of Copenhagen at 1 site in Denmark.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 31 Aug 2015. 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 Denmark. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Gingival inflammation (time frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination). The study lists 2 primary outcomes in all. 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 NCT02357199, which also lists 3 linked publications.
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 31 Aug 2015; AzTrials last refreshed its copy on 7 Nov 2026.