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

Chronic Kidney Disease Clinical Trial

— NEPHRODENT  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02114281
• Other study ID #: CHUBX 2013/11
• Status: Completed
• Phase: N/A
• First received: February 4, 2014
• Last updated: January 19, 2018
• Start date: September 16, 2014
• Est. completion date: July 19, 2017

Study information

• Verified date: January 2018
• Source: University Hospital, Bordeaux
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical 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. 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 88
• Est. completion date: July 19, 2017
• Est. primary completion date: July 19, 2017
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• Chronic Kidney Disease
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Other:
• Care

• Not care

Locations

Country	Name	City	State
France	Service de néphrologie, transplantation et dialyse - Hôpital Pellegrin	Bordeaux

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Bordeaux

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	12 months after the inclusion
Secondary	Evolution of nutrition statement	food survey, biological assessment and body composition by bioelectrical impedance analysis	12 months after the inclusion
Secondary	Evolution of chronic inflammation		12 months after the inclusion
Secondary	Progression of chronic kidney disease (CKD)		12 months after the inclusion
Secondary	Compliance with dental treatments in CKD patients		12 months after the inclusion
Secondary	Evolution of CKD diseases with/without dental treatments in those patients who need dental treatments		12 months after the inclusion