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

NCT02114281 | Completed

• 1 other identifier: CHUBX 2013/11
• Study Type: interventional
• Target: 88
• Locations: 1 country
• Sites: 1

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.

Conditions

Chronic Kidney Disease

Keywords

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

Outcome Measures

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

  12 months after the inclusion

Secondary Outcomes (5)

• Evolution of nutrition statement

  12 months after the inclusion

• Evolution of chronic inflammation

  12 months after the inclusion

• Progression of chronic kidney disease (CKD)

  12 months after the inclusion

• Compliance with dental treatments in CKD patients

  12 months after the inclusion

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

  12 months after the inclusion

Study Arms (2)

Care

EXPERIMENTAL

Patient with dental care

Other: Care

Not care

ACTIVE COMPARATOR

Patient with not dental care

Other: Not care

Interventions

Care OTHER

Care

Not care OTHER

Not care

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

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

Sponsors & Collaborators

• University Hospital, Bordeaux: lead

Study Sites (1)

Service de néphrologie, transplantation et dialyse - Hôpital Pellegrin

Bordeaux, 33076, France

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Periodontitis; Dental Caries; Halitosis; Inflammation

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Tooth Demineralization; Tooth Diseases; Signs and Symptoms, Digestive; Signs and Symptoms

Study Officials

• Claire RIGOTHIER, MD

  University Hospital Bordeaux, France

  PRINCIPAL INVESTIGATOR

• Antoine BENARD, MD

  University Hospital Bordeaux, France

  STUDY CHAIR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: February 4, 2014
• First Posted: April 15, 2014
• Study Start: September 16, 2014
• Primary Completion: July 19, 2017
• Study Completion: July 19, 2017
• Last Updated: January 23, 2018

Record last verified: 2018-01

Locations

FR (1)