Loss of teeth due to accident, extraction or localized periodontal diseases
Conditions
Interventions
For this two-arm non-inferiority within-subject randomized clinical trial, 75 patients in need of rehabilitation with dental implants in areas of the mandible or posterior maxilla (premolars and/or mo
D25.339.312
Sponsors
Universidade de São Paulo - Faculdade de Odontologia
M3 Health Indústria e Comércio de Produtos Médicos, Odontológicos e Correlatos Sociedade Anônima
Eligibility
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: Patients who are a minimum age of 18 years and a maximum of 70 years; with good general health; who have signed the Informed Consent Form; in need of rehabilitation with dental implants in areas of mandible or posterior maxilla (premolars and/or molars); with bacterial plaque index = 20%; bleeding rate = 20%; sufficient alveolar bone volume for an implant of 8 or 10mm length, diameter of 3.5mm, 4.00mm or 4.5mm, with bone quality type I-III and no associated bone regeneration required
Exclusion criteria
Exclusion criteria: Pregnant and lactating women; uncontrolled diabetes; history of chemotherapy or radiotherapy in the last 5 years; radiation therapy to areas of the head and neck; use of immunosuppressants, bisphosphonates or prolonged use of corticosteroids; smokers; alcohol or drug abuse; untreated periodontitis; history of previous bone augmentate in the implant installation region; presence of residual roots at the site to receive the implant; type IV bone density; individuals with connective tissue disorders or bone metabolic diseases; postmenopausal osteoporosis or other systemic diseases that may affect bone metabolism; need for guided bone regeneration at the time of implant placement
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The objective of this study will be to evaluate the non-inferiority of implants produced by additive manufacturing loaded in 30 days when compared with those loaded in 90 days, in relation to marginal bone loss, after 01 (one) year of follow-up. | — |
Secondary
| Measure | Time frame |
|---|---|
| Evaluate implant success rate, plaque index, peri-implant bleeding index, clinical probing depth, clinical level of insertion over 1 year after placement. | — |
Countries
Brazil
Contacts
Public ContactThais Rojas
M3 Health Indústria e Comércio de Produtos Médicos, Odontológicos e Correlatos Sociedade Anônima
Outcome results
None listed