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

NCT04020458 · Status: TERMINATED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 11

Last updated 2023-07-21

No results posted yet for this study

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.

Conditions

Interventions

PROCEDURE

dental intervention

Dental intervention plan for Group 1 and 3 subjects with periodontitis only, i) Full mouth intraoral X-rays (FMX) ii. Full periodontal exam, diagnosis, Oral hygiene instructions (OHI) iii. RX: 7 days of p.o. metronidazole (250mg)/amoxicillin (500mg) T.I.D., combined with local chlorhexidine rinses (not for subjects with Kidney transplant). iv. Single visit intensive scaling and root planning (SRP) (full mouth) v. Re-evaluation after 4-6 weeks (referral for definitive treatment) vi. Extraction of teeth deemed hopeless based on periodontal, endodontic or restorative considerations vii. Caries control, sedative dressing (palliative), referral to endodontic dentist for root canal treatment (RCT)

Sponsors & Collaborators

  • Augusta University

    lead OTHER

Principal Investigators

  • Christopher W Cutler · Dental College of Georgia-Augusta University

Study Design

Allocation
NON_RANDOMIZED
Purpose
PREVENTION
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
21 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2018-11-09
Primary Completion
2022-01-04
Completion
2022-01-04

Countries

  • United States

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04020458 on ClinicalTrials.gov