Comparative Study Between Lyophilized or Frozen Bone Allografts for Sinus-lifting

Study Overview
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Brief Summary
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Bone resorption and atrophy in maxillary posterior region is due to severe periodontal disease and is consequent tooth extractions. Sinus pneumatisation can occur after tooth extraction and alveolar bone loss. Consequently, bone-reducing volume at that region is a great challenge to implantodontists. Sinus lifting surgery have been practiced since 80's and many biomaterials have been used to solve filling issues to maintain the sinus floor lifted in a position that can allow dental implants installation. Bone grafts have shown to be the best choice of filling grafts. Despite autologous bone are the gold standard filling biomaterial it is associates with great mortality and morbidity. So, bone allografts from tissue bank had been shown to be an advantageous alternative. Lyophilized or freeze tissue bone are the most common allografts but literature is poor in randomized controlled parallel clinical trials regarding those filling grafts for sinus lifting. The aim of this study is to perform a randomized controlled clinical trial comparing two bone allografts: lyophilized and freeze bone allografts from human bone tissue bank. The investigators want to verify which one can develop greater osteogenesis, if is there any difference between them regarding the architectural trabeculae formation, if there are different patterns of reabsorption and finally if is there any differences between them regarding primary and lately dental implants stability. To answer those questions the investigators propose firstly, to carry out microtomographic and histological analysis from trephine bone samples after six months of sinus lifting and grafting in healthy participants undergoing osseointegrated dental implants. Secondly, the primary and lately implant stability is going to be achieved employing Resonance Frequency Analysis (RFA).

Official Title
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Histological and Microtomographic Comparative Study Between Lyophilized or Frozen Bone Allografts for Sinus-lifting: A Randomized Clinical Trial

Conditions
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Disorder of Maxillary Sinus, Accessory; Bone, Bone Atrophy

Intervention / Treatment
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* Procedure: freeze bone allograft
* Procedure: lyophilized bone allograft


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: healthy totally or partially edentulous patients, bilaterally, in upper premolar or molar region; presenting maxillary sinus lifting necessity with bilateral alveolar bone height lower than 5mm and indication for at least one osseointegrated dental implant in premolar or molar region. Exclusion Criteria: recent sinusitis history hypersensibility for sinus allergens, tabagism, ethylism severe periodontal disease, diabetes, hypertension. Cases that occur schneiderian membrane perforation will be excluded from the final sample.

Ages Eligible for Study
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Minimum Age: 30 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: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: group lyophilized bone allograft<br>sinus lifting with tissue bank lyophilized bone filling | Procedure: lyophilized bone allograft<br>* sinus lifting filling procedure employing lyophilized bone allograft from tissue bone bank.<br>|
| Active Comparator: group freeze bone allograft<br>sinus lifting with freeze bone bank filling | Procedure: freeze bone allograft<br>* sinus lifting filling procedure employing freeze bone allograft from tissue bone bank.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| volume of bone neoformation in mm3 | computational software for analysis the micro CT scanning of trephine bone samples images | six months after grafting | 
| area of bone neoformation in μm2 | IMAGEJ histomorphometric software for analysis of trephine bone samples micrographic images | six months after grafting | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| dental implants stability value | primary implant stability by Resonance Frequency Analysis (RFA) in ISQ | six months after grafting | 
| dental implants stability value | late stability by Resonance Frequency analysis (RFA) in ISQ | six months after dental implant | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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bone, maxillary sinus