TerminatedNot Applicable

Dental Intervention Plan for Chronic Kidney Disease Patients Awaiting or With Kidney Transplant

Stopped: Funding lapse and poor enrollment rate

United States11 participantsStarted 2018-11-09

Plain-language summary

The study aims to understand why dental infections in end-stage kidney patients results in poor outcomes for kidney functions and eventually transplant. Further, if an active dental treatment is provided to such patients, does it helps improve the kidney functional parameters, and eventually results in better survival of kidney transplant. In addition, the molecular markers that result in altered interactions between the blood cells and bacteria in these patients will be identified and compared with those found in a healthy subjects, or subjects with gum disease but no kidney disease. Besides, if any of the makers of altered interactions found in the blood can be found to be altered in the saliva samples from the patients with gum disease (periodontitis), and kidney disease, it will help to develop a non-invasive oral risk test for predicting outcomes of kidney transplant survival.

Who can participate

Age range21 Years – 75 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Exclusion criteria

✕. Subjects of both sexes, 21 to 75 years of age will be included.
✕. Subjects must have moderate to severe generalized periodontitis (PD) (Group 1) (n=50) or no PD (Group 2) (n=50). PD is defined as a patient in the 3rd or later decades of life with the presence of at least 20 natural teeth, \>30% of which exhibit: probing depth \> 6mm, attachment loss \> 3 mm, bleeding on probing, alveolar bone crest \> 3 mm from cemento-enamel junction \[CEJ\]. Healthy controls will also have \> 20 teeth, but no alveolar bone loss, attachment loss or BOP and alveolar bone crest 1-2 mm from the CEJ.
✕. No kidney disease
✕. All potential subjects must sign an informed consent prior to study enrollment.
✕. Periodontal treatment (i.e., surgical or nonsurgical) within 3 months prior to enrollment.
✕. Treatment with antibiotics within 3 months prior to enrollment.
✕. Presence of heart murmur, history of rheumatic fever, valvular disease, prosthetic joint replacement necessitating antibiotic prophylaxis.
✕. Kidney disease

What they're measuring

Kidney transplant outcome

Timeframe: 3 years

Trial details

NCT IDNCT04020458

SponsorAugusta University

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2022-01-04

View on ClinicalTrials.gov More Chronic Kidney Disease trials