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
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
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
NCT ID
NCT02114281
First Posted
February 4, 2014
Last Updated
January 19, 2018
Sponsor
University Hospital, Bordeaux
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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