ClinicalTrials.gg
CompletedNCT02114281NEPHRODENTUpdated May 14, 2026

Oral and Dental Health Status in Patients Suffering From Chronic Kidney Disease

An interventional study of Care and Not care in Chronic Kidney Disease, sponsored by University Hospital, Bordeaux. Completed at 1 site in France. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-05-14.

Sponsored by University Hospital, Bordeaux · Not applicable, Interventional, and Prevention

Phase
Not applicable
Study type
Interventional
Enrollment
88
Allocation
Non-randomized
Ages
18 Years and older
Sex
All
01

Study 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. 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.

02

Conditions studied

  • Chronic Kidney Disease

Keywords

  • Oral Health
  • Periodontitis
  • Tooth cavities
  • Saliva
  • Halitosis
  • Mucosa
  • Chronic kidney disease
  • Inflammation
  • Nutrition
03

In context

Renal Insufficiency, Chronic

3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.

This study's enrollment of 88 is above the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

University Hospital, Bordeaux is the lead sponsor of 806 studies on the registry; 197 are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years and older
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • 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

Exclusion criteria

Exclusion Criteria:

  • Persons having a current law affair
  • Persons suffering from psychosis or severe mental impairment
05

Study design

Phase
Not applicable
Primary purpose
Prevention
Allocation
Non-randomized
Intervention model
Parallel assignment
Masking
None (open label)
Enrollment
88 participants (actual)

Study arms

  • Experimental
    Care

    Patient with dental care

    Other: Care

  • Active comparator
    Not care

    Patient with not dental care

    Other: Not care

Interventions

  • OtherCare
  • OtherNot care
06

What researchers measure

Primary outcomes

  1. 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

    Time frame: 12 months after the inclusion

Secondary outcomes

  1. Evolution of nutrition statement

    food survey, biological assessment and body composition by bioelectrical impedance analysis

    Time frame: 12 months after the inclusion

  2. Evolution of chronic inflammation

    Time frame: 12 months after the inclusion

  3. Progression of chronic kidney disease (CKD)

    Time frame: 12 months after the inclusion

  4. Compliance with dental treatments in CKD patients

    Time frame: 12 months after the inclusion

  5. Evolution of CKD diseases with/without dental treatments in those patients who need dental treatments

    Time frame: 12 months after the inclusion

07

Study locations

1 site
  • Service de néphrologie, transplantation et dialyse - Hôpital Pellegrin
    Bordeaux, Bordeaux 33076, France
08

References and documents

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 28181635 ↗
  • Rigothier 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 ↗
09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on May 14, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02114281
Responsible party
Sponsor
First posted
Apr 15, 2014
Start date
Sep 16, 2014
Primary completion
Jul 19, 2017
Completion
Jul 19, 2017
Last update
May 14, 2026

Study contacts

Claire RIGOTHIER, MD
principal investigator · University Hospital Bordeaux, France
Antoine BENARD, MD
study chair · University Hospital Bordeaux, France

Oversight

Data monitoring committee
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Jan 2018. You cannot join it, but the record below documents what was studied.

Follow this study

Get an email when the registry record changes — status, dates, results — or when someone posts here.

Sign in to follow

Discussion

Questions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.

Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.

Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.

Start the discussion