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

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

Status
Completed
Phases
Unknown
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02114281
Acronym
NEPHRODENT
Enrollment
88
Registered
2014-04-15
Start date
2014-09-16
Completion date
2017-07-19
Last updated
2026-05-14

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic Kidney Disease

Keywords

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

Brief 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.

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.

Interventions

OTHERCare
OTHERNot care

Sponsors

University Hospital, Bordeaux
Lead SponsorOTHER

Study design

Allocation
NON_RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No

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

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

Design outcomes

Primary

MeasureTime frameDescription
Evolution of the status of oral health, which will be evaluated through several dental epidemiological indices (composite measure)12 months after the inclusionThe 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

Secondary

MeasureTime frameDescription
Evolution of nutrition statement12 months after the inclusionfood survey, biological assessment and body composition by bioelectrical impedance analysis
Evolution of chronic inflammation12 months after the inclusion
Progression of chronic kidney disease (CKD)12 months after the inclusion
Compliance with dental treatments in CKD patients12 months after the inclusion
Evolution of CKD diseases with/without dental treatments in those patients who need dental treatments12 months after the inclusion

Countries

France

Contacts

PRINCIPAL_INVESTIGATORClaire RIGOTHIER, MD

University Hospital Bordeaux, France

STUDY_CHAIRAntoine BENARD, MD

University Hospital Bordeaux, France

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: May 15, 2026