Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone: a Clinical, Histologic and Histomorphometric Evaluation
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University of Sao Paulo
- Enrollment
- 16
- Locations
- 2
- Primary Endpoint
- Bone height measured in millimeters using the panoramic radiography reconstructions
Study Overview
Brief 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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 25 Years to 60 Years (Adult)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •Presenting a distance between alveolar crest and maxillary sinus of 2 to 9 millimeters.
Exclusion Criteria
- •History of periodontal surgery at the area on the last 12 months
- •Use of drugs that affect periodontal tissues (eg: anticonvulsants, calcium channel blockers, cyclosporine, bisphosphonates, hormone-based, contraceptives, steroids)
- •Diabetics
- •History of head and neck radiotherapy
Outcomes
Primary Outcomes
Bone height measured in millimeters using the panoramic radiography reconstructions
Time Frame: Six months
It will be measured the distance between the alveolar ridge and the maxillary sinus in panoramic radiography reconstructions taken before and after sinus lift.
Secondary Outcomes
- Descriptive histologic analysis of biopsy samples performed by two trained and previously calibrated examiners(Six months)
- Quantitative histologic analysis of biopsy samples using Leahy et al. (2013) score(Six months)
- Histomorfometric analysis of biopsy samples using percentage of different tissues evaluated at ImageJ(Six months)
Investigators
Adriana Campos Passanezi SantAna
Associate Professor
University of Sao Paulo