sub-periosteum dental implants /peri-implant diseases
Conditions
Interventions
30 patients will undergo surgery to insert 4 HE implants in the lower arch. After 60 days there will be the reopening of the implants and placement of 4 healers. Patients must return after 7 days, and
Sponsors
universidade paulista
universidade paulista
Eligibility
Age
40 Years to 80 Years
Inclusion criteria
Inclusion criteria: Thirty individuals, total male or female, will be selected, with a minimum age of 40 and a maximum age of 80 years, with an indication for mandibular rehabilitation.
Exclusion criteria
Exclusion criteria: smoking, pregnant, lactating, obese individuals, as well as those with systemic diseases (osteoporosis, immunological disorders, hepatitis, diabetes mellitus, etc.) will be excluded. Use of corticosteroids, non-steroidal anti-inflammatory drugs, immunosuppressive drugs, estrogen and modulators of estrogen, alendronate and calcitonin receptors during the 6 months prior to the study will also be considered exclusion factors. Subjects who do not have enough bone tissue for the placement of dental implants and who require additional surgical procedures before or during their installation will also be excluded. Individuals with a history of bone grafts at sites indicated for implant placement will also be excluded.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| For the calculation of the sample size a priori, I consider as the primary outcome the measurement of the clinical parameter depth of the probe. The type I error of 0.05 and the type II error of 0.2 were adopted. Based on the study design, the size of the herd defining to have clinical relevance of the difference in mean between treatments and 1mm, after the period of 6 months of use, when compared to 6 months of use of the protocol-type prosthesis and 6 months of the type-prosthesis over denture. It is important to note that it is a cross-sectional study, so all patients will use both types of prosthesis. The correlation adopted between the repeated measures was 0.5 based on Walters et al. Trials, 2019.The ideal number of patients was 24. | — |
Secondary
| Measure | Time frame |
|---|---|
| secondary outcomes are not expected. | — |
Countries
Brazil
Contacts
Public ContactFernanda ribeiro
UNIP
Outcome results
None listed