Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-25 @ 12:13 AM
Ignite Modification Date:
2025-12-25 @ 12:13 AM
NCT ID:
NCT04020458
Eligibility Criteria:
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.
Healthy Volunteers:
True
Sex:
ALL
Minimum Age:
21 Years
Maximum Age:
75 Years
Study:
NCT04020458
Study Brief:
Protocol Section:
NCT04020458