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

Primary Purpose

Chronic Kidney Disease

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
Care
Not care
Sponsored by
University Hospital, Bordeaux
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Chronic Kidney Disease focused on measuring Oral Health, Periodontitis, Tooth cavities, Saliva, Halitosis, Mucosa, Chronic kidney disease, Inflammation, Nutrition

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

  • Service de néphrologie, transplantation et dialyse - Hôpital Pellegrin

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

Care

Not care

Arm Description

Patient with dental care

Patient with not dental care

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Evolution of nutrition statement
food survey, biological assessment and body composition by bioelectrical impedance analysis
Evolution of chronic inflammation
Progression of chronic kidney disease (CKD)
Compliance with dental treatments in CKD patients
Evolution of CKD diseases with/without dental treatments in those patients who need dental treatments

Full Information

First Posted
February 4, 2014
Last Updated
January 19, 2018
Sponsor
University Hospital, Bordeaux
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1. Study Identification

Unique Protocol Identification Number
NCT02114281
Brief Title
Oral and Dental Health Status in Patients Suffering From Chronic Kidney Disease
Acronym
NEPHRODENT
Official Title
Oral and Dental Health Status in Patients Suffering From Chronic Kidney Disease
Study Type
Interventional

2. Study Status

Record Verification Date
January 2018
Overall Recruitment Status
Completed
Study Start Date
September 16, 2014 (Actual)
Primary Completion Date
July 19, 2017 (Actual)
Study Completion Date
July 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Bordeaux

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease
Keywords
Oral Health, Periodontitis, Tooth cavities, Saliva, Halitosis, Mucosa, Chronic kidney disease, Inflammation, Nutrition

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
88 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Care
Arm Type
Experimental
Arm Description
Patient with dental care
Arm Title
Not care
Arm Type
Active Comparator
Arm Description
Patient with not dental care
Intervention Type
Other
Intervention Name(s)
Care
Intervention Type
Other
Intervention Name(s)
Not care
Primary Outcome Measure Information:
Title
Evolution of the status of oral health, which will be evaluated through several dental epidemiological indices (composite measure)
Description
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 Outcome Measure Information:
Title
Evolution of nutrition statement
Description
food survey, biological assessment and body composition by bioelectrical impedance analysis
Time Frame
12 months after the inclusion
Title
Evolution of chronic inflammation
Time Frame
12 months after the inclusion
Title
Progression of chronic kidney disease (CKD)
Time Frame
12 months after the inclusion
Title
Compliance with dental treatments in CKD patients
Time Frame
12 months after the inclusion
Title
Evolution of CKD diseases with/without dental treatments in those patients who need dental treatments
Time Frame
12 months after the inclusion

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Claire RIGOTHIER, MD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Principal Investigator
First Name & Middle Initial & Last Name & Degree
Antoine BENARD, MD
Organizational Affiliation
University Hospital Bordeaux, France
Official's Role
Study Chair
Facility Information:
Facility Name
Service de néphrologie, transplantation et dialyse - Hôpital Pellegrin
City
Bordeaux
ZIP/Postal Code
33076
Country
France

12. IPD Sharing Statement

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

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