Chronic Kidney DiseaseNEPHRODENTNCT02114281
Oral and Dental Health Status in Patients Suffering From Chronic Kidney Disease
A study testing Care and Not care in people with Chronic Kidney Disease, run by University Hospital, Bordeaux at 1 site in France.
Trial summary
A large panel of oral and dental diseases exist in patients suffering from chronic kidney disease (CKD) in end-stage renal disease: it concerns teeth, peridontium, alveolar bone and saliva and it has been already described in the literature. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- Care and Not care
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 88 participants
- Where
- 1 siteFrance
- Study dates
- 16 Sep 2014to 19 Jul 2017
- 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
- CKD patients, stage 2 to 5, under treatment in CHU de Bordeaux
- Aged more than 18 years old
- A free, informed and written consent will be established
- Must have a medical plan
- Patients have had no dental cares 6 months before the inclusion date
Who cannot join
- Persons having a current law affair
- Persons suffering from psychosis or severe mental impairment
Trial locations and contacts
1 site in 1 country.
France1 site
Service de néphrologie, transplantation et dialyse - Hôpital Pellegrin
Bordeaux, Bordeaux, 33076
About this study
A large panel of oral and dental diseases exist in patients suffering from chronic kidney disease (CKD) in end-stage renal disease: it concerns teeth, peridontium, alveolar bone and saliva and it has been already described in the literature. The consequences of oral diseases in systemic health are substantial, including increase of inflammatory parameters, alteration of nutrition and increase of cardiovascular risk factors. It has been shown before that several oral diseases can be considered as cardiovascular risk factor in the general population and in diabetic patients through the chronic inflammatory pathway. In CKD patients, the influence of oral diseases on the progression of the chronic kidney disease is not yet established, as most of the studies are focused on stage 5 CKD or dialysis patients. That's why the interactions between dental health and CKD will be evaluated in this population of patients, at different stages of the disease (stages 2 to 5).
The main objective will be to describe the oral diseases at each stage of CKD. Secondary objectives will be: (1) To evaluate the link between the oral health and the chronic kidney disease stage, the nutritional and inflammatory status; (2) Among patients needing dental treatments, to evaluate after 6 months and 12 months whether dental cares have an influence on nutrition parameters, inflammatory status and CKD; (3) to evaluate the completion of dental treatments after the dental consultation including advises on dental health.
Read the detailed description
The consequences of oral and dental diseases in general health are substantial, including acute infectious process starting from teeth or peridontium, benign or malignant diseases starting from mucosa or teeth/peridontium and an overall reduction of nutrition indices and a decrease of quality of life markers. More recently, an augmentation of systemic inflammatory reaction markers has been shown correlated with periodontal diseases, leading to an increase of cardiovascular diseases and/or diabetic risk in those patients. A large panel of oral and dental diseases has been described in patients suffering from chronic kidney disease (CKD) in a terminal stage or dialysis (haemodialysis and peritoneal dialysis). In CKD patients, the influence of oral diseases on the progression of the chronic kidney disease is not established today, as most of the studies are focused on stage 5 CKD or dialysis patients. That's why the interactions between dental health and CKD will be evaluated in these patients, at different stages of the disease (stages 2 to 5). In this study, it is hypothesized that the augmentation of inflammation and the alteration of nutrition due to oral diseases have an impact on the alteration of CKD patients, through the chronic inflammatory pathway. We will evaluate the oral and dental health at Day 0, 6 months and 12 months using several indices: the oral hygiene-simplified index, the community periodontal index in treatment needs index, the decayed missing filled per tooth index, the number of functional teeth index, the oral health impact profile index, the saliva composition, the evaluation of halitosis and a mucosa evaluation. In parallel, an evaluation of the influence of chronic oral diseases on nutrition, inflammation and progression of chronic kidney disease will be done: biological check-up, nutrition intake statement and body mass index.
- Conditions
- Chronic Kidney Disease
- Being tested
- Care, Not care
- Keywords
- Oral Health, Periodontitis, Tooth cavities, Saliva, Halitosis, Mucosa, Chronic kidney disease, Inflammation, Nutrition
- Medical subject headings
- Renal Insufficiency, Chronic, Periodontitis, Dental Caries, Halitosis, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
CareOther
Not careOther
| Study group | Role | What they receive |
|---|---|---|
| Care | Experimental | Patient with dental care Receives: Other: Care |
| Not care | Active comparator | Patient with not dental care Receives: Other: Not care |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evolution of the status of oral health, which will be evaluated through several dental epidemiological indices (composite measure)
The primary outcome is a composite measure including :
- Oral Hygiene Index-Simplified index (OHI-S)
- Community Periodontal Index in Treatment Needs index (CPITN)
- Decayed Missing Filled per Tooth Index (DMF-T)
- Number of Functional Teeth index (FS-T)
- Oral Health Impact Profile index (OHIP)
- Saliva Check (stimulated and non stimulated saliva flow, pH, buffer activity)
- Halitosis evaluation (quantification of sulfur volatils compounds)
- Mucosa evaluation
Measured: 12 months after the inclusion
Secondary outcomes (5)
Evolution of nutrition statement
food survey, biological assessment and body composition by bioelectrical impedance analysis
Measured: 12 months after the inclusion
Evolution of chronic inflammation
Measured: 12 months after the inclusion
Progression of chronic kidney disease (CKD)
Measured: 12 months after the inclusion
Compliance with dental treatments in CKD patients
Measured: 12 months after the inclusion
Evolution of CKD diseases with/without dental treatments in those patients who need dental treatments
Measured: 12 months after the inclusion
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2014 (estimated)
- Study start16 Sep 2014
- Primary completion19 Jul 2017
- Study completion19 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- More trials run by University Hospital, BordeauxThe 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
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 88 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Bordeaux
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Claire RIGOTHIER, MD, Principal investigator, University Hospital Bordeaux, FranceAntoine BENARD, MD, Study chair, University Hospital Bordeaux, France
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02114281
- Sponsor's protocol ID
- CHUBX 2013/11
- Other IDs
- 2013-A01548-37
- Acronym
- NEPHRODENT
- Status last verified
- Jan 2018
- First submitted
- 4 Feb 2014
- Last updated
- 14 May 2026
- Results posted
- No
- Data monitoring committee
- No
Publications
Roubaud-Baudron C, Forestier E, Fraisse T, Gaillat J, de Wazieres B, Pagani L, Ingrand I, Bernard L, Gavazzi G, Paccalin M. Tolerance of subcutaneously administered antibiotics: a French national prospective study. Age Ageing. 2017 Jan 8;46(1):151-155. doi: 10.1093/ageing/afw143.
PubMed 28181635Rigothier C, Catros S, Benard A, Samot J, Quintin O, Combe C, Larabi I, Massy Z, Alvarez JC. Association between Dental Scores and Saliva Uremic Toxins. Toxins (Basel). 2023 Nov 20;15(11):666. doi: 10.3390/toxins15110666.
PubMed 37999529
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Oral and Dental Health Status in Patients Suffering From Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02114281
- Acronym / sponsor ID
- NEPHRODENT / CHUBX 2013/11
- Conditions
- Chronic Kidney Disease
- Keywords
- Oral Health, Periodontitis, Tooth cavities, Saliva, Halitosis, Mucosa, Chronic kidney disease, Inflammation
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 88 participants (actual)
- Lead sponsor
- University Hospital, BordeauxUniversity, hospital or other
- Study start
- 16 Sep 2014 (actual)
- Primary completion
- 19 Jul 2017 (actual)
- Study completion
- 19 Jul 2017 (actual)
- First posted
- 15 Apr 2014 (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.
A large panel of oral and dental diseases exist in patients suffering from chronic kidney disease (CKD) in end-stage renal disease: it concerns teeth, peridontium, alveolar bone and saliva and it has been already described in the literature. The consequences of oral diseases in systemic health are substantial, including increase of inflammatory parameters, alteration of nutrition and increase of cardiovascular risk factors. It has been shown before that several oral diseases can be considered as cardiovascular risk factor in the general population and in diabetic patients through the chronic inflammatory pathway. In CKD patients, the influence of oral diseases on the progression of the chronic kidney disease is not yet established, as most of the studies are focused on stage 5 CKD or dialysis patients. That's why the interactions between dental health and CKD will be evaluated in this population of patients, at different stages of the disease (stages 2 to 5).
The main objective will be to describe the oral diseases at each stage of CKD. Secondary objectives will be: (1) To evaluate the link between the oral health and the chronic kidney disease stage, the nutritional and inflammatory status; (2) Among patients needing dental treatments, to evaluate after 6 months and 12 months whether dental cares have an influence on nutrition parameters, inflammatory status and CKD; (3) to evaluate the completion of dental treatments after the dental consultation including advises on dental health.
Detailed description
The consequences of oral and dental diseases in general health are substantial, including acute infectious process starting from teeth or peridontium, benign or malignant diseases starting from mucosa or teeth/peridontium and an overall reduction of nutrition indices and a decrease of quality of life markers. More recently, an augmentation of systemic inflammatory reaction markers has been shown correlated with periodontal diseases, leading to an increase of cardiovascular diseases and/or diabetic risk in those patients. A large panel of oral and dental diseases has been described in patients suffering from chronic kidney disease (CKD) in a terminal stage or dialysis (haemodialysis and peritoneal dialysis). In CKD patients, the influence of oral diseases on the progression of the chronic kidney disease is not established today, as most of the studies are focused on stage 5 CKD or dialysis patients. That's why the interactions between dental health and CKD will be evaluated in these patients, at different stages of the disease (stages 2 to 5). In this study, it is hypothesized that the augmentation of inflammation and the alteration of nutrition due to oral diseases have an impact on the alteration of CKD patients, through the chronic inflammatory pathway. We will evaluate the oral and dental health at Day 0, 6 months and 12 months using several indices: the oral hygiene-simplified index, the community periodontal index in treatment needs index, the decayed missing filled per tooth index, the number of functional teeth index, the oral health impact profile index, the saliva composition, the evaluation of halitosis and a mucosa evaluation. In parallel, an evaluation of the influence of chronic oral diseases on nutrition, inflammation and progression of chronic kidney disease will be done: biological check-up, nutrition intake statement and body mass index.
Study design
- Primary purpose
- Prevention
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Care | Experimental | Other: CarePatient with dental care |
| Not care | Active comparator | Other: Not carePatient with not dental care |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- CKD patients, stage 2 to 5, under treatment in CHU de Bordeaux
- Aged more than 18 years old
- A free, informed and written consent will be established
- Must have a medical plan
- Patients have had no dental cares 6 months before the inclusion date
Key exclusion criteria (2 listed)
- Persons having a current law affair
- Persons suffering from psychosis or severe mental impairment
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 |
|---|---|---|
| Care | Other | Care |
| Not care | Other | Not care |
Primary outcome
Evolution of the status of oral health, which will be evaluated through several dental epidemiological indices (composite measure)
Time frame: 12 months after the inclusion
The primary outcome is a composite measure including : * Oral Hygiene Index-Simplified index (OHI-S) * Community Periodontal Index in Treatment Needs index (CPITN) * Decayed Missing Filled per Tooth Index (DMF-T) * Number of Functional Teeth index (FS-T) * Oral Health Impact Profile index (OHIP) * Saliva Check (stimulated and non stimulated saliva flow, pH, buffer activity) * Halitosis evaluation (quantification of sulfur volatils compounds) * Mucosa evaluation
5 secondary outcomes
Evolution of nutrition statement
Time frame: 12 months after the inclusion
Evolution of chronic inflammation
Time frame: 12 months after the inclusion
Progression of chronic kidney disease (CKD)
Time frame: 12 months after the inclusion
Compliance with dental treatments in CKD patients
Time frame: 12 months after the inclusion
Evolution of CKD diseases with/without dental treatments in those patients who need dental treatments
Time frame: 12 months after the inclusion
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 14 May 2026.
- Results publication: PubMed 28181635Roubaud-Baudron C, Forestier E, Fraisse T, Gaillat J, de Wazieres B, Pagani L, Ingrand I, Bernard L, Gavazzi G, Paccalin M. Tolerance of subcutaneously administered antibiotics: a French national prospective study. Age Ageing. 2017 Jan 8;46(1):151-155. doi: 10.1093/ageing/afw143.
- Results publication: PubMed 37999529Rigothier C, Catros S, Benard A, Samot J, Quintin O, Combe C, Larabi I, Massy Z, Alvarez JC. Association between Dental Scores and Saliva Uremic Toxins. Toxins (Basel). 2023 Nov 20;15(11):666. doi: 10.3390/toxins15110666.
Related trials for Chronic Kidney Disease
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Not yet recruiting
An Individuation Intervention to Reduce Socioeconomic Disparities in Chronic Kidney Disease Care
Chronic Kidney Diseases
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.
Claire RIGOTHIER, MD principal investigator
University Hospital Bordeaux, France
Antoine BENARD, MD study chair
University Hospital Bordeaux, France
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Care and Not care in people with Chronic Kidney Disease, run by University Hospital, Bordeaux at 1 site in France.
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 5 inclusion and 2 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 14 May 2026. 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 France. 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?
Evolution of the status of oral health, which will be evaluated through several dental epidemiological indices (composite measure) (time frame: 12 months after the inclusion). 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 NCT02114281, which also lists 2 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 14 May 2026.