ICTRP Search Portal

Main

Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register.

Register:	ClinicalTrials.gov
Last refreshed on:	7 September 2015
Main ID:	NCT02357199
Date of registration:	28/01/2015
Prospective Registration:	No
Primary sponsor:	University of Copenhagen
Public title:	Interventional Study Targeting Oral Infections in Patients With Chronic Kidney Disease
Scientific title:	Interventional Study Targeting Oral Infections in Patients With Chronic Kidney Disease
Date of first enrolment:	January 2015
Target sample size:	93
Recruitment status:	Completed
URL:	https://clinicaltrials.gov/show/NCT02357199
Study type:	Interventional
Study design:	Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Investigator, Outcomes Assessor), Primary Purpose: Prevention
Phase:	N/A

Countries of recruitment
Denmark

Contacts

Name:	Siri B Jensen, DDS, PhD
Address:
Telephone:
Email:
Affiliation:	University of Copenhagen

Key inclusion & exclusion criteria

Inclusion Criteria:

- 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

Exclusion Criteria:

- Patients not capable of following the research protocol

- Legally unavailable

- Need of antibiotic prophylaxis with dental treatment

- Heart valve surgery

Age minimum: 18 Years
Age maximum: N/A
Gender: Both

Health Condition(s) or Problem(s) studied

Renal Insufficiency, Chronic

Mouth Diseases

Intervention(s)

Other: Intensive oral care & didactic training

Primary Outcome(s)

Gingival inflammation [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

C-reactive protein, plasma [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Secondary Outcome(s)

Renal function: Bicarbonate [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Saliva composition: Total calcium [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Whole saliva flow rate, unstimulated [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Hematologic status: Transferrin [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Hematologic status: Erythrocytes [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Saliva composition: Albumin [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Oral candidiasis [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Renal function: Potassium [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Hematologic status: Leukocytes [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Medical Outcomes Study Short Version [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Saliva composition: Amylase activity [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Hematologic status: Thrombocytes [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Oral Health Impact Profile [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Saliva composition: Sodium [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Periodontal disease [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Renal function: Albumin [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Calcium metabolism [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Phosphate metabolism [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Saliva composition: Secretory IgA [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Renal function: Carbamide [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Renal function: Sodium [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Dental bacterial plaque [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Saliva composition: Inorganic phosphate [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Hematologic status: Iron [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Saliva composition: Total protein [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Saliva composition: Chloride [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Whole saliva flow rate, stimulated [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Hematologic status: Hemoglobin [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Renal function: Creatinine [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Saliva composition: Potassium [Time Frame: Change from baseline examination (before oral care intervention) at 3-months follow-up examination]

Secondary ID(s)

102-2084/14-3000

Source(s) of Monetary Support

Please refer to primary and secondary sponsors

Secondary Sponsor(s)

Danish Council for Independent Research - Medical Sciences

Rigshospitalet, Denmark

The Danish Dental Association

Ethics review

Results

Results available:
Date Posted:
Date Completed:
URL:

Disclaimer: Trials posted on this search portal are not endorsed by WHO, but are provided as a service to our users. In no event shall the World Health Organization be liable for any damages arising from the use of the information linked to in this section. None of the information obtained through use of the search portal should in any way be used in clinical care without consulting a physician or licensed health professional. WHO is not responsible for the accuracy, completeness and/or use made of the content displayed for any trial record.