Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone

Study Overview
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Brief Summary
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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
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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.

Official Title
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Sinus Lift With Newly Forming Bone and Inorganic Bovine Bone: a Clinical, Histologic and Histomorphometric Evaluation

Conditions
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Maxillary Sinus

Intervention / Treatment
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* Procedure: Sinus lift
* Procedure: Surgical alveolus
* Procedure: Inorganic bovine bone + newly forming bone
* Procedure: Inorganic bovine bone
* Device: Collagen membrane


Participation Criteria
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Eligibility Criteria
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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) Pregnant Smokers Diabetics History of head and neck radiotherapy

Ages Eligible for Study
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Minimum Age: 25 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Test group<br>Surgical alveolus + maxillary sinus lift with inorganic bovine bone + newly forming bone + collagen membrane | Procedure: Sinus lift<br>* Using a lateral access, the Schneider membrane will be elevated using curettes allowing the insertion of graft material.<br>Procedure: Surgical alveolus<br>* Using a round diamond bur, a surgical alveolus will be created on an toothless ridge region.<br>Procedure: Inorganic bovine bone + newly forming bone<br>* 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.<br>Device: Collagen membrane<br>* At the end of the sinus lift, a collagen membrane will be used to obliterate the graft inside the maxillary sinus.<br>|
| Active Comparator: Control group<br>Maxillary sinus lift with inorganic bovine bone + collagen membrane | Procedure: Sinus lift<br>* Using a lateral access, the Schneider membrane will be elevated using curettes allowing the insertion of graft material.<br>Procedure: Inorganic bovine bone<br>* Maxillary sinus lift will be done with inorganic bovine bone.<br>Device: Collagen membrane<br>* At the end of the sinus lift, a collagen membrane will be used to obliterate the graft inside the maxillary sinus.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone height measured in millimeters using the panoramic radiography reconstructions | It will be measured the distance between the alveolar ridge and the maxillary sinus in panoramic radiography reconstructions taken before and after sinus lift. | Six months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Descriptive histologic analysis of biopsy samples performed by two trained and previously calibrated examiners | On the surface and around the particles of the materials with the newformed reactive tissue, it was analyzed the presence and absence of the following tissue and reactive cellular elements: granulation tissue, newly formed blood vessels, fibroblasts, osteoblasts and mineralized bone matrix, foreign body type granuloma, macrophages, inflammatory multinucleated giant cells. | Six months | 
| Quantitative histologic analysis of biopsy samples using Leahy et al. (2013) score | Quantification of the reactional and reparative phenomena related to cellular and tissue organization on biopsed samples were made using Leahy et al. (2013) score. | Six months | 
| Histomorfometric analysis of biopsy samples using percentage of different tissues evaluated at ImageJ | The tissue sections were captured with 4x and 10x objective and images were recorded and later analyzed in the ImageJ software. The proportions of vital bone, cortical bone, medullary bone, remnant non-vital particles and connective tissue were quantified separately and expressed as percentages. | Six months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Maxillary Sinus, Sinus lifting, Bone graft