Study enrolment and randomization
stroke, heart disease
STROKE, UNCONTROLLED HYPERTENSION, GROUP B, HEART DISEASE
Randomizing software was used to randomly allocate patients on a 1:1 ratio to non-surgical periodontal therapy (NSPT) + Ozone group, and NSPT. The patients in group A (n = 90) received non-surgical periodontal treatment plus gaseous ozone therapy. Patients in Group B (n = 90) received non-surgical periodontal treatment. All follow-up periodontal evaluations were performed by the same two calibrated operators. The unblinded clinician determined the treatment for the subjects. Participants were not blinded because the motivation session was carried out according to the allocation. Prior to a consultant appointment, patients visit the department of Dentistry for periodontal clinical parameters assessments. During this phase, patients were provided with a general information sheet. Patients who met study eligibility criteria signed the informed consent, after which they were enrolled into the research study and, randomized to either NSPT + Ozone treatment (Test Group, A) or the control treatment (Control Group, B) according to the randomization sequence. Secondly, eligible patients were actively involved in the research study by screening phase. Subjects provided informed consent prior to initiation of any study procedures. Individuals were excluded if they presented declined cognitive function and unable to make informed consent, underwent periodontal treatment within least 12 months, and systemic antibiotic therapy within the last 6 months, pregnancy, or breast feeding, having uncontrolled hypertension, history of heart disease or stroke which might interfere with systemic antioxidative status.