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

NCT04020458 | Terminated DMC

• 1 other identifier: 1295706
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

Brief 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

Chronic Kidney Disease; Chronic Periodontitis, Generalized, Moderate

Keywords

Kidney transplant, Immunoprofiling

Outcome Measures

Primary Outcomes (1)

• Kidney transplant outcome

  % allograft survival

  3 years

Study Arms (3)

Periodontitis, no kidney disease

ACTIVE COMPARATOR

Dental intervention 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)

Procedure: dental intervention

Experimental- chronic kidney disease

ACTIVE COMPARATOR

Dental intervention 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)

Procedure: dental intervention

Control- no Periodontitis or kidney disease.

NO INTERVENTION

Only regular dental cleaning

Interventions

dental intervention PROCEDURE

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)

Experimental- chronic kidney disease; Periodontitis, no kidney disease

Eligibility Criteria

• Age: 21 Years - 75 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may not qualify if:

• There will be three groups in the study:
• Control groups: There will be 2 control groups. The data from these two groups will help establish the baseline for the different parameters to be evaluated in the experimental population.
• \) Group 1: moderate to severe generalized periodontitis (PD) (no kidney disease).
• 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
• Cancer or chronic viral infections such as HIV and hepatitis B
• Inability to take Metronidazole and Amoxicillin combination due to allergy.
• Experimental group:
• \) Group 3: Patients with chronic kidney disease : i. Group 3a- stage 5 (without dialysis, glomerular filtration rate (GFR) \< 20)/ stage 5D (on dialysis), awaiting kidney transplant. (n=50) ii. Group 3b- Stages 2-4 (patients who have had either a living donor transplant (n=25), or deceased donor transplant within the last 2 years (n=25), with /without no history of rejection of kidney transplant) (total n=50).

Sponsors & Collaborators

• Augusta University: lead

Study Sites (1)

Augusta University-Dental College of Georgia

Augusta, Georgia, 30912, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Chronic Periodontitis; Lymphoma, Follicular

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; Periodontitis; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases; Lymphoma, Non-Hodgkin; Lymphoma; Neoplasms by Histologic Type; Neoplasms; Lymphoproliferative Disorders; Lymphatic Diseases; Hemic and Lymphatic Diseases; Immunoproliferative Disorders; Immune System Diseases

Study Officials

• Christopher W Cutler

  Dental College of Georgia-Augusta University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Chair and Professor

Study Record Dates

• First Submitted: July 10, 2019
• First Posted: July 16, 2019
• Study Start: November 9, 2018
• Primary Completion: January 4, 2022
• Study Completion: January 4, 2022
• Last Updated: July 21, 2023

Record last verified: 2023-07

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)