Trials / Completed
CompletedNCT03419338
Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone
Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone: a Clinical, Histologic and Histomorphometric Evaluation
- Status
- Completed
- Phase
- N/A
- Study type
- Interventional
- Enrollment
- 16 (actual)
- Sponsor
- University of Sao Paulo · Academic / Other
- Sex
- All
- Age
- 25 Years – 60 Years
- Healthy volunteers
- Accepted
Summary
The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the gain of bone volume in sinus lift procedures. For that, it will be compared the tomographic bone gain 6 months after surgery between a group that received inorganic bovine bone alone (n=8) and a group that received inorganic bovine bone associated with NFB (n=8).
Detailed description
The aim of this study is to evaluate the efficacy of newly forming bone graft (NFB) in the gain of bone volume in sinus lift procedures. It will be recruited for this study individuals 25-60 years of age, both genders, presenting a missing tooth at an upper premolar or molar region with 2-9 mm of remaining bone between alveolar ridge crest and sinus floor and the existence of an edentulous ridge or at least one tooth condemned to extraction. Sinus will be treated by NFB mixed to inorganic bovine bone - IBB (test; n= 8) or IBB (control; n= 8). The volume of bone tissue will be evaluated by computerized tomography obtained at baseline examination and 6 months after surgery. After this period, biopsies of hard tissue will be obtained during implant placement for histologic and histomorphometric analysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| PROCEDURE | Sinus lift | Using a lateral access, the Schneider membrane will be elevated using curettes allowing the insertion of graft material. |
| PROCEDURE | Surgical alveolus | Using a round diamond bur, a surgical alveolus will be created on an toothless ridge region. |
| PROCEDURE | Inorganic bovine bone + newly forming bone | Maxillary sinus lift will be done with inorganic bovine bone associated with newly forming bone. The newly forming bone will be collected from surgical alveolus previous prepared. |
| PROCEDURE | Inorganic bovine bone | Maxillary sinus lift will be done with inorganic bovine bone. |
| DEVICE | Collagen membrane | At the end of the sinus lift, a collagen membrane will be used to obliterate the graft inside the maxillary sinus. |
Timeline
- Start date
- 2010-03-01
- Primary completion
- 2013-06-01
- Completion
- 2013-06-30
- First posted
- 2018-02-01
- Last updated
- 2018-02-01
Locations
1 site across 1 country: Brazil
Source: ClinicalTrials.gov record NCT03419338. Inclusion in this directory is not an endorsement.