Diabetes Mellitus
Conditions
Interventions
This is an interventional, experimental, quantitative, and prospective study, comprising in vitro preclinical phases and a randomized, controlled, parallel, three-arm clinical trial (propolis hydrogel
chlorhexidine hydrogel — positive control, with a total of 15 patients
placebo hydrogel/saline irrigation — negative control, with a total of 45 patients), resulting in a total of 90 patients, double-blind, with follow-up at 21, 45, and 90 days. It is a study concerning
Sponsors
Universidade de São Paulo
Universidade de São Paulo
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Both genders; with a minimum age of 18 years and no maximum age limit; minimum of 14 teeth present in the mouth (excluding third molars and teeth indicated for extraction); diagnosis of periodontitis stage 2 or 3 and grade B or C (at least 30% of teeth with at least one site with probing pocket depth (PPD) and clinical attachment level (CAL) equal or higher than 5 mm and bleeding on probing); systemically healthy patients; patients diagnosed with Diabetes Mellitus
Exclusion criteria
Exclusion criteria: Smoking, pregnancy; total edentulism; recent periodontal treatment; recent use of antibiotics; patients who refused to sign the consent form
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Expected outcome 1: When comparing pro-inflammatory cytokine levels between the study groups, it is expected that those concentrations decrease after treatment. | — |
Secondary
| Measure | Time frame |
|---|---|
| Expected outcome 2: When comparing anti-inflammatory cytokine levels between the study groups, it is expected that those concentrations increase after treatment.;Expected outcome 3: Regarding the product used, it is expected that the chlorhexidine and propolis gels will show superior post-treatment results compared to the placebo gel and saline solution.;Expected outcome 4: The propolis gel is expected to show clinical results comparable to those of the chlorhexidine gel, confirming its potential as an alternative for periodontal treatment. | — |
Countries
Brazil
Contacts
Public ContactNathalya Moura
Universidade de São Paulo, Faculdade de Odontologia de Ribeirão Preto
Outcome results
None listed