Doenças Periodontais
Conditions
Interventions
This is a clinical, interventional, longitudinal, analytical, non-randomized study with parallel groups and pre- and post-periodontal treatment evaluation. The study will include a total of 60 partici
therefore, there will be no participant randomization. No masking will be applied, characterizing the study as open-label, since both participants and researchers will be aware of the intervention per
Sponsors
Instituto de Ciência e Tecnologia de São José dos Campos
Instituto de Ciência e Tecnologia de São José dos Campos
Eligibility
Age
35 Years to No maximum
Inclusion criteria
Inclusion criteria: Type 2 diabetics with periodontitis: diagnosis of periodontitis stages III or IV, grades B or C; age over 35 years; both sexes; diagnosis of type 2 diabetes mellitus – DM2; glycated hemoglobin levels between 7% and 11%; clinical attachment loss greater than 3 mm in two non-adjacent teeth and greater than or equal to 5 mm in at least 30% of the teeth; presence of a minimum of 15 teeth; formal consent through the Free and Informed Consent Form – TCLE. Type 2 diabetics without periodontitis: biofilm-induced gingivitis, associated with local or systemic factors; age over 35 years; both sexes; diagnosis of DM2 for more than 5 years; glycated hemoglobin levels between 7% and 11%; presence of at least 15 teeth; signature of the TCLE. Normoglycemic patients with periodontitis: diagnosis of periodontitis stages III or IV, grades B or C; age over 35 years; both sexes; clinical attachment loss greater than 3 mm in two non-adjacent teeth and greater than or equal to 5 mm in at least 30% of the teeth; presence of a minimum of 15 teeth; formal consent through the TCLE
Exclusion criteria
Exclusion criteria: Cardiovascular diseases, cancer, autoimmune diseases, gastrointestinal diseases, skin diseases, arthritis, lupus; pregnant or lactating women; smokers; patients who have undergone periodontal treatment in the last 12 months; recent change (within the last 3 months) in glycemic index or medication; other systemic inflammatory diseases
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| A statistically and clinically significant reduction in the number and or percentage of sites with probing depths greater than or equal to 5 millimeters is expected after periodontal treatment, verified by clinical periodontal examination with a millimeter periodontal probe, based on the reduction in the number and or percentage of sites and the average difference in millimeters between measurements taken at baseline and after 90 days of follow-up;A statistically and clinically significant reduction in the number and or percentage of sites with bleeding on probing associated with probing depths greater than or equal to 5 millimeters after periodontal treatment is expected, as verified by clinical periodontal examination with a millimeter periodontal probe, based on the reduction in the number and or percentage of sites with bleeding on probing between baseline measurements and after 90 days of follow-up | — |
Secondary
| Measure | Time frame |
|---|---|
| No secondary outcomes are expected | — |
Countries
Brazil
Contacts
Public ContactÍtza Amarisis Pinto
Instituto de Ciência e Tecnologia de São José dos Campos
Outcome results
None listed