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:
2025-12-24 @ 4:14 PM
Ignite Modification Date:
2025-12-24 @ 4:14 PM
NCT ID:
NCT03343366
Eligibility Criteria:
Inclusion Criteria:
* Age between 35 to 65 years patients suffering from moderate to severe CP at baseline and having HbA1c level ≥7% and \<10% at baseline with already diagnosed T2DM at least an year ago will be included as study sample. Moreover, those currently under oral glycemic therapy, having at least 16 natural teeth for the entire study duration and not under any definitive periodontal treatment since last 6 months of baseline visit will be considered as inclusion criteria along with no oral soft tissue lesions and those willing to sign informed consent will be considered to be recruited for this trial
Exclusion Criteria:
* Pregnant or breast feeding women
* Gestational Diabetes
* Patients currently receiving dialysis
* Patients with cardiac pacemakers
* Alcoholic
* Patients with any serious concurrent disease or complication with \<1 year of life expectancy.
* Patients suffering from myelo-proliferating disorder (such as sickle cell disease) or under any such treatment that promotes a shift in the hemoglobin pattern.
* Under any anti-inflammatory drugs (daily for \>7 consecutive days) within last 2 months of baseline visit, other than low dose aspirin prescribed for Cardio-vascular disease
* Under any systemic immunosuppressive drugs like corticosteroids, cyclosporine etc.
* Under any systemic antibiotics for \>7 consecutive days within last four weeks of baseline visit.
* No medication for oral problems during last one month and during follow-up period that may affect interventions and HbA1c levels
* Any change in diabetes related medications in last 3 months of baseline visit, such as change in dose of any one hyperglycemic drug therapy by more than two-fold, addition or subtraction of an oral hypoglycemic agent or addition of insulin.
* Patients requiring any surgical (such as flap-surgery) or any non-surgical periodontal care that is restricted throughout study period depending upon the participants' group he/she may belong to.
* Patients with a history of night-grinding/ bruxism
* Patients with a history of allergic reaction with metronidazole
* Patients with mentally or/ and gross physical disability
* Failure to liaise on with the study protocol over the next 6 months
* With drawl from participation
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Maximum Age:
65 Years
Study:
NCT03343366
Study Brief:
Protocol Section:
NCT03343366