Interventional Study Targeting Oral Infections in Patients With Chronic Kidney Disease

NCT02357199 | Completed DMC

• 1 other identifier: 102-2084/14-3000
• Study Type: interventional
• Target: 93
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to investigate the prevalence of oral infection in chronic renal disease patients and to examine whether a focused oral hygiene intervention can reduce oral infection leading to reduced systemic inflammatory parameters in chronic renal disease patients in hemodialysis, chronic renal disease patients waiting for kidney transplantation, and chronic renal disease patients who has been transplanted 1-1½ year previously. The results will be compared to a gender- and age-matched healthy control group.

Conditions

Mouth Diseases; Renal Insufficiency, Chronic

Keywords

Mouth Diseases; Renal Insufficiency, Chronic; Intervention Studies

Outcome Measures

Primary Outcomes (2)

• Gingival inflammation

  Gingival inflammation measured by gingivitis index

  Change from baseline examination (before oral care intervention) at 3-months follow-up examination

• C-reactive protein, plasma

  Blood sample

  Change from baseline examination (before oral care intervention) at 3-months follow-up examination

Secondary Outcomes (30)

• Dental bacterial plaque

  Change from baseline examination (before oral care intervention) at 3-months follow-up examination

• Periodontal disease

  Change from baseline examination (before oral care intervention) at 3-months follow-up examination

• Whole saliva flow rate, unstimulated

  Change from baseline examination (before oral care intervention) at 3-months follow-up examination

• Whole saliva flow rate, stimulated

  Change from baseline examination (before oral care intervention) at 3-months follow-up examination

• Saliva composition: Sodium

  Change from baseline examination (before oral care intervention) at 3-months follow-up examination

Other Outcomes (1)

• Dental caries

  Baseline examination (before oral care intervention), 3-months follow-up examination

Study Arms (2)

Intensive oral care & didactic training

EXPERIMENTAL

Professional (dental hygienist) intensive oral care intervention and individual patient training/didactic instruction to promote patient compliance and patient capability of oral preventive measures in a long-term perspective.

Other: Intensive oral care & didactic training

Standard oral care

NO INTERVENTION

Standard oral care protocol consisting of referral by staff in the Department of Nephrology to general dental practitioner followed by patient self-administration of tooth brushing, fluoride toothpaste and oral lubricants.

Interventions

Intensive oral care & didactic training OTHER

Professional (dental hygienist) intensive oral care intervention and individual patient training/didactic instruction to promote patient compliance and patient capability of oral preventive measures in a long-term perspective.

Intensive oral care & didactic training

Eligibility Criteria

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

You may qualify if:

• Patients on a kidney transplant waiting list or patients who have had a kidney transplant (1-1½ year previously)
• Dentate patients (\>10 teeth)
• Age \>18 years
• Danish language

You may not qualify if:

• Patients not capable of following the research protocol
• Legally unavailable
• Need of antibiotic prophylaxis with dental treatment
• Heart valve surgery

Sponsors & Collaborators

• University of Copenhagen: lead
• Rigshospitalet, Denmark: collaborator
• Danish Council for Independent Research - Medical Sciences: collaborator
• The Danish Dental Association: collaborator

Study Sites (1)

Department of Odontology, Faculty of Health Sciences, University of Copenhagen

Copenhagen, DK-2200, Denmark

Location

Related Publications (3)

• Kato S, Chmielewski M, Honda H, Pecoits-Filho R, Matsuo S, Yuzawa Y, Tranaeus A, Stenvinkel P, Lindholm B. Aspects of immune dysfunction in end-stage renal disease. Clin J Am Soc Nephrol. 2008 Sep;3(5):1526-33. doi: 10.2215/CJN.00950208. Epub 2008 Aug 13.

  PMID: 18701615 BACKGROUND

• McIntyre C, Harper I, Macdougall IC, Raine AE, Williams A, Baker LR. Serum C-reactive protein as a marker for infection and inflammation in regular dialysis patients. Clin Nephrol. 1997 Dec;48(6):371-4.

  PMID: 9438096 BACKGROUND

• Thorman R. Oral health in patients with chronic kidney disease. Stockholm, Sweden: Karolinska Institutet; 2009

  BACKGROUND

MeSH Terms

Conditions

Mouth Diseases; Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Stomatognathic Diseases; 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

Study Officials

• Siri B Jensen, DDS, PhD

  University of Copenhagen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor, DDS, PhD

Study Record Dates

• First Submitted: January 28, 2015
• First Posted: February 6, 2015
• Study Start: January 1, 2015
• Primary Completion: August 1, 2015
• Study Completion: August 1, 2015
• Last Updated: August 31, 2015

Record last verified: 2015-08

Locations

DK (1)