Alveolar bone loss
Conditions
Interventions
24 patients with bilateral posterior atrophic maxilla requiring bilateral maxillary sinus lift augmentation for implant placement will be recruited for the present study. The split mounth design will
Control side: in the other maxillary sinus of the 24 patients the sinus lift augmentation will be performed and the cavity will be grafted with only Bio-Oss®.
In the test and control side, a collagen
Procedure/surgery
Other
Sponsors
Faculdade de Odontologia de Araraquara - Universidade Estadual Paulista (UNESP)
Faculdade de Odontologia de Araraquara - Universidade Estadual Paulista (UNESP)
Eligibility
Age
18 Years to 100 Years
Inclusion criteria
Inclusion criteria: Minimum age of 18 years old; bilateral edentulism in the maxilla posterior region; 5 mm of minimum bone width and up to 4.0 mm of crestal bone height; written informed consent.
Exclusion criteria
Exclusion criteria: Compromised general healthy condition; uncontrolled diabetes; pregnancy; smokers; alcohol and drug abusers; irradiated patients; therapies with bisphosphonates; blood platelet disorders; chronic sinusitis and patients suffering from any pathology in the maxillary sinus.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The primary outcome of the present study is bone regeneration. This primary outcome will be evaluated from biopsies obtained during the second surgery intervention for implant placement. Bone biopsies will be harvested from the alveolar crest using a trephine bur The histomorphometric analysis will be performed by a single examiner blinded to the experimental groups. | — |
Secondary
| Measure | Time frame |
|---|---|
| Secondary outcome 1- Evaluation of the volumetric stability of the bone graft by means of tomographic analysis. Bone graft volume will be evaluate in two tomography scans, one in the tomography scan performed after the regenerative procedure (T1) and one in the tomography scan performed after 4 or 8 months of healing (T2). Based on the difference in volume between these two scans, the percentage of bone resorption will be calculated. A specific software (Planmeca Romexis 3D module, Planmeca Oy, Helsinki, Finland) will be used to calculate the bone volume in each CT scan.;Secondary outcome 2- Evaluation of the implant primary stability by resonance frequency analysis using the Osstell. This device determine the implant stability quotient (ISQ) measured for each implant that varies from 1 to 100. The implant stability will be measured immediately after implant installation.;Secondary outcome 3- Survival of implants and occurrence of complications. Longitudinal follow-up of the implants will be done to identify early or late implant failure and occurrence of complications. After implant installatiom, the patients will be evaluated every 3 months in the first year and every six months from the second year. Patients will be followed up for 5 years. This secondary outcome will be determined based on clinical, including examination of the implant with periodontal probe, and radiographic (periapical radiography) analyses. | — |
Countries
Brazil
Contacts
Public ContactDaniela Zandim-Barcelos
Faculdade de Odontologia de Araraquara - Universidade Estadual Paulista (UNESP)
Outcome results
None listed