Clinical trial · Interventional
Dental Intervention Plan for Chronic Kidney Disease Patients Awaiting or With Kidney Transplant
- Source
- ClinicalTrials.gov
- Retrieved
- Sep 8, 2026
- Layer
- normalized (units and labels harmonized; values unchanged)
- Run
- ING-CLINICALTRIALS-20260908-000001
Why stopped (as posted): Funding lapse and poor enrollment rate
Summary
Brief summary (as posted)
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
Conditions (2)
Free-text conditions as registered, with the CancerIndex entity they were reconciled to and the match type.
| Condition (as posted) | Mapped entity | Match | Confidence |
|---|---|---|---|
| Chronic Kidney Disease | — | UNRESOLVED | — |
| Chronic Periodontitis, Generalized, Moderate | — | UNRESOLVED | — |
Interventions
Interventions (1)
| Intervention | Type | Mapped drug | Match |
|---|---|---|---|
| dental intervention | Procedure | — | UNRESOLVED |
Design
Arms and outcomes
Arms (3)
- type
- ACTIVE_COMPARATOR
- label
- Periodontitis, no kidney disease
- description
- 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)
- interventionNames
- Procedure: dental intervention
- type
- ACTIVE_COMPARATOR
- label
- Experimental- chronic kidney disease
- description
- 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)
Eligibility
Eligibility (as posted)
- Sex
- All
- Minimum age
- 21 Years
- Maximum age
- 75 Years
Show eligibility criteria text
Inclusion and Exclusion Criteria Inclusion and Exclusion Criteria List the inclusion/exclusion criteria: 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. 1\) Group 1: moderate to severe generalized periodontitis (PD) (no kidney disease). 2\) Group 2: healthy controls, no PD or kidney disease. Inclusion Criteria 1. Subjects of both sexes, 21 to 75 years of age will be included. 2. 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. 3. No kidney disease 4. All potential subjects must sign an informed consent prior to study enrollment. Exclusion Criteria 1. Periodontal treatment (i.e., surgical or nonsurgical) within 3 months prior to enrollment. 2. Treatment with antibiotics within 3 months prior to enrollment. 3. Presence of heart murmur, history of rheumatic fever, valvular disease, prosthetic joint replacement necessitating antibiotic prophylaxis. 4. Kidney disease 5. Cancer or chronic viral infections such as HIV and hepatitis B 6. Inability to take Metronidazole and Amoxicillin combination due to allergy. Experimental group: 3\) 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). Inclusion Criteria 1. Subjects of both sexes, 21 to 75 years of age will be included. 2. All potential subjects must sign an informed consent prior to study enrollment. 3. All potential subjects should be able to drive or be driven to the DCG for dental treatment and follow-up visits. 4. For Group 3b subjects, post-transplant group, glomerular filtration rate with creatinine clearance rate should be in the range of 1.5 - 1.9 ml/min. This will yield a more uniform subject population for statistical analysis of the data. Exclusion Criteria 1. Active, chronic viral infections such as HIV, Hepatitis B, Hepatitis C (these patients are immunocompromised and on antiviral drugs, which might result in an altered immune profile for such patients). 2. Inability to take Metronidazole and Amoxicillin combination due to allergy or poor kidney function.
References
Publications (0)
Data not yet available