Periodontitis
Conditions
Interventions
This is a randomized controlled clinical trial, triple-blind, with two arms, conducted in patients with periodontitis associated or not with type 2 diabetes mellitus. Blinding will be applied to clini
to patients, who will not be aware of which treatment modality they are receiving, as both ozonized oil and non-ozonized olive oil (placebo) will be administered identically, making distinction imposs
and to researchers responsible for statistical analysis, who will receive data without identifying the group to which each participant belongs, ensuring impartiality in the analyses. Participants will
Sponsors
Departamento de Odontologia - Faculdade de Ciências da Saúde - UNB
Departamento de Odontologia - Faculdade de Ciências da Saúde - UNB
Eligibility
Inclusion criteria
Inclusion criteria: Women, men, and all gender identities and sexual orientations. Diagnosis of stage III or IV periodontitis, defined as a chronic multifactorial inflammatory disease associated with a dysbiotic biofilm and characterized by the progressive destruction of the dental attachment apparatus. The diagnostic criteria for stage III or IV include interproximal attachment loss of 5 mm or more at the worst site or radiographic bone loss extending to the middle or apical third of the root, according to the 2018 classification of periodontal and peri-implant diseases and conditions. Presence of at least 10% of sites with bleeding on periodontal probing. Presence of at least two sites with probing depth = 5 mm and bleeding on probing. Diagnosis of type 2 diabetes mellitus, with HbA1c = 6.5%. Treatment for diabetes mellitus with hypoglycemic medications and/or insulin
Exclusion criteria
Exclusion criteria: Periodontal treatment in the last 6 months. Use of antimicrobial and immunomodulatory medications in the last three months. Presence of systemic conditions (other than type 2 diabetes mellitus) that interfere with periodontal status, including HIV, immune disorders, morbid obesity (BMI = 40), or underweight (BMI = 18.5). Pregnant or lactating individuals. Tobacco use
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Periodontal clinical parameters, measured by the bleeding on probing index (BOP), probing depth (PD), clinical attachment level (CAL), and the reduction in the number of periodontal pockets with probing depth =5 mm. | — |
Secondary
| Measure | Time frame |
|---|---|
| Changes in the microbiome;Levels of inflammatory cytokines;Proteomic analysis of saliva | — |
Countries
Brazil
Contacts
Public ContactElisa Araújo
Universidade de Brasília
Outcome results
None listed