Periodontal disease Chronic periodontitis
Conditions
Interventions
Eighty male and female patients from Ribeirão Preto School of Dentistry - USP will be selected and randomly divided (Office Excel® Worksheet) into 4 groups of 20 patients each (n = 20), in a randomize
MIANI et al., 2012
BASTOS, 2015
CALEFI, 2017) namely:
• Group 1 (Control) - periodontal debridement with ultrasound (DPUS)
• Group 2 - DPUS + Subantimicrobial Doxycycline Gel (DOXI-SDD)
• Group 3 - DPUS + metronidazole gel (MDZ) + (DOXI-SDD)
• Group 4 - DPUS + Movie (MDZ) + (DOXI-SDD).
Drug
Sponsors
Faculdade De Odontologia de Ribeirão Preto
Fundação de Amparo à Pesquisa do Estado de São Paulo
Eligibility
Age
30 Years to 75 Years
Inclusion criteria
Inclusion criteria: Patients with chronic periodontitis, with clinical insertion level equal to or greater than 6mm in two or more teeth and probing depth equal to or greater than 5mm in one or more periodontal sites (MACHTEI et al., 1992); Age range from 30 to 75 years old; Not having used antibiotics for at least 3 months; No history of allergy to the components present in the formulations to be tested (MDZ and Tetracyclines).
Exclusion criteria
Exclusion criteria: Severe cardiovascular disease; Pharmacokinetic problems such as nephropathy, liver disease, etc. Patients with a history of tetracycline allergy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Through validated primary surrogate clinical outcomes, it is expected to improve the clinical parameters of periodontitis over 12 months after the interventions. ;In vivo evaluation of the effect of the formulations in improving the clinical parameters of periodontitis (probing depth, clinical level of insertion and bleeding on probing), using the Florida Probe ™ system, at times T0 (baseline) - before periodontal therapy and application of formulations; T1 - after one week; T2 - after 1 month; T3 - after 6 months, and T4 - after 12 months of the treatment application. | — |
Secondary
| Measure | Time frame |
|---|---|
| The absence and / or decrease of pathogens related to chronic periodontitis is expected after the proposed treatments, over 12 months after the interventions.;Through secondary outcomes (evaluation of microbial diversity), the absence and / or decrease of pathogens related to chronic periodontitis is expected through the evaluation of the subgingival microbiota, using the genomic sequencing method, at the same times described in item 2 of the specific objectives. | — |
Countries
Brazil
Contacts
Public ContactVinicius Pedrazzi
Faculdade De Odontologia de Ribeirão Preto
Outcome results
None listed