clinical trial, dental implantation, antibiotic prophylaxis, infections
Conditions
Interventions
Group G1 (without antibiotic prophylaxis) control / 30 patients / will use placebo capsules in the preoperative and postoperative (oral)
Group G2 (preoperative prophylaxis, 1g Amoxicillin) test group
Sponsors
Hospital Universitário Onofre Lopes
Departamento de Odontologia-Universidade Federal do Rio Grande do Norte
Eligibility
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: Need for dental implants for rehabilitation; surgery for installing two-stage dental implants; up to 5 implants in the same surgical procedure; those who agreed to participate after explaining the research, by signing the informed consent form
Exclusion criteria
Exclusion criteria: Risk of bacterial endocarditis; any systemic or local immunodeficiency; uncontrolled diabetes mellitus; previous radiation therapy in the head and neck area; need for a bone augmentation procedure (grafts) concomitant with implant installation; 1-stage implant surgery; immediate implants and in cases of immediate loading • Allergy to penicillin, dexamethasone or sodium dipyrone; • Presence of chronic or acute infection in the vicinity of the planned implant site; • Already on antibiotic and anti-inflammatory treatment for any other reason; • Treated or being treated with intravenous or oral antiresorptive medications (bisphosphonates and denosumab); • Pregnant or infant; • Enrolled in other clinical studies whose interventions could interfere with this research; • Under 18 years of age or unable to sign the consent form.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Clinically assess whether patients using prophylactic antibiotic therapy, compared with those who do not, will experience greater loss of implants, less incidence of postoperative infection and less postoperative pain. In addition, to assess whether there will be differences in results using two different antibiotic prophylaxis protocols for the rate of implant loss, for incidence of postoperative infection and pain. To evaluate the differences in means between the control and study groups, as well as between study subgroups, the t test will be used, in which the p value will be fixed at 0.05 to detect the level of statistical significance. The null hypothesis will be that there will be no difference in success and complications between patients who will receive prophylactic antibiotics compared to others who will not use it, against the alternative hypothesis that there will be a statistically significant difference. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcomes are not expected. | — |
Countries
Brazil
Contacts
Public ContactGleysson de Assis
Outcome results
None listed