Osseointegration
Conditions
Interventions
This is a randomized, controlled, single-blind clinical trial conducted using a split-mouth design, aimed at evaluating the performance of sticky bone prepared with Bio-Oss® or Nanosynt® in the contex
Group 2 – Bio-Oss® alone (n = 12 sites)
Group 3 – PRF + Nanosynt® (n = 12 sites)
and Group 4 – Nanosynt® alone (n = 12 sites). The surgical procedure will consist of maxillary sinus floor elevation with bone grafting according to the allocated group. After a three-month healing pe
Sponsors
Universidade Federal de Uberlândia
Faculdade de Odontologia da Universidade Federal de Uberlândia
Eligibility
Age
18 Years to 60 Years
Inclusion criteria
Inclusion criteria: Be between 18 and 60 years old; have the need for bilateral maxillary sinus floor elevation for subsequent installation of osseointegrated implants; present bone availability associated with the alveolar ridge adjacent to the maxillary sinus of less than or equal to 3mm; be in good systemic health; have at least 4 months of healing in the socket after tooth extraction
Exclusion criteria
Exclusion criteria: Smokers; uncontrolled diabetics; individuals with chronic or aggressive periodontitis; patients using medications that alter bone metabolism; patients with chronic upper respiratory tract infections; patients who chronically use anti-inflammatory drugs and antibiotics; individuals with bruxism; alcoholics; drug addicts; pregnant women or those who wish to become pregnant in the next year; history of radiotherapy treatment in the head and neck region; individuals with pathologies that affect bone metabolism; patients who had a major membrane rupture during the trans-surgical procedure.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To evaluate tissue composition (% newly formed bone, % soft tissue, and % residual bone substitute), as well as the volume and microarchitecture of grafted maxillary sinus areas treated with different bone substitutes, with or without the use of PRF. Four experimental groups will be compared (PRF + Bio-Oss®, Bio-Oss® alone, PRF + Nanosynt®, and Nanosynt® alone), with an expected minimum detectable difference of 10% between groups. Outcomes will be assessed through histomorphometric and three-dimensional tomographic analyses. | — |
Secondary
| Measure | Time frame |
|---|---|
| To evaluate the success, survival, and stability rates of dental implants placed in maxillary sinus lift sites grafted with different biomaterials, with or without the use of PRF. Four groups will be compared (PRF + Bio-Oss®, Bio-Oss® alone, PRF + Nanosynt®, and Nanosynt® alone), with an expected minimum detectable difference of 10% between groups. Outcomes will be assessed through standardized peri-implant clinical evaluation (probing depth, bleeding on probing, and plaque index), measurement of implant stability, and assessment of marginal bone levels using digital periapical radiographs. | — |
Countries
Brazil
Contacts
Public ContactPriscilla Soares
Faculdade de Odontologia da Universidade Federal de Uberlândia
Outcome results
None listed