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 @ 4:16 PM
Ignite Modification Date:
2025-12-24 @ 4:16 PM
NCT ID:
NCT04051866
Eligibility Criteria:
Inclusion Criteria:
* Diagnosis of type 2 diabetes (code CIAP-2 T90)
* With at least one determination of HbA1c in the last 3 months HbA1c\> 7.5%
* No changes in hypoglycemic or insulin treatment in the last 3 months.
* With generalized moderate-severe chronic periodontal disease.
* Presence of at least 16 natural teeth.
* Informed consent.
Exclusion Criteria:
* Patients with basic systemic diseases with oral involvement (autoimmune diseases of oral involvement: oral lichen planus, lupus, pemphigus, pemphigoid)
* Limited life expectancy.
* Urgent diabetic complications in the 30 days prior to the study.
* They need extensive oral treatment: fistulous trajectories, cellulitis, pulpitis or other oral infections.
* Pregnant, with desire for pregnancy in the 12 months of study or breastfeeding.
* That they have received periodontal treatment in the last 6 months.
* That they have received antibiotic and / or anti-inflammatory regimen continued at least in the last 4 weeks prior to the study (except low doses of acetylsalicylic acid).
* In treatment with corticosteroids or immunosuppressive drugs.
* On dialysis or risk of bleeding (anticoagulant treatment).
* Dependent on alcohol.
* Patients who require antibiotic prophylaxis for the realization of SPR.
* Patients with uncontrolled systemic diseases (with the exception of diabetes): cardiovascular, lung, liver, kidney disease in advanced stages or neoplasms.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
35 Years
Study:
NCT04051866
Study Brief:
Protocol Section:
NCT04051866