Maxillary Sinus Grafting With Deproteinized Porcine or Bovine Bone Mineral.

Study Overview
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Brief Summary
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The present study aimed to compare the histomorphometrically evaluated new bone formation, the radiographically measured graft stability and the clinical implant outcome between maxillary sinuses grafted either with deproteinized porcine bone mineral (DPBM) or deproteinized bovine bone mineral (DBBM). Conclusions: From a clinical point of view, the present results demonstrate that DPBM provides for comparable bone formation and stable graft dimension and high implant success rates combined with healthy peri-implant condition:

Detailed Description
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Materials and Methods: Thirty maxillary sinuses in 28 participants were initially included and randomly assigned to the test group (TG;DPBM: n=15) or the control group (CG,DBBM: n=15). After a healing period (6 months) bone core biopsies were axially retrieved in the molar site for histological/ histomorphometrical analysis of new bone formations. In addition, radiographically measured graft stability as well as the clinical implant outcome (implant survival/success/peri-implant health) were assessed at the 1-year and 3-year follow-up evaluations.

Official Title
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Clinical, Radiographic and Histological/Histomorphometric Analysis of Maxillary Sinus Grafting With Deproteinized Porcine or Bovine Bone Mineral: a Randomized Controlled Clinical Trial

Conditions
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Histomorphometry

Intervention / Treatment
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* Procedure: Maxillary sinus augmentation


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: maxillary sinus atrophy in the need of sinus augmentation, 2 stage augmentation procedure Exclusion Criteria: drug abuse, additional augmentation procedure, heavy smokers, bisphosphonate abuse

Ages Eligible for Study
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Minimum Age: 18 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
Interventional Model Description: randomized clinical trial.
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: bovine bone<br>Patients received maxillary sinus augmentation grafting with bovine bone mineral | Procedure: Maxillary sinus augmentation<br>* Maxillary sinus grafting with 2 different xenogenic materials<br>|
| Active Comparator: Porcine bone mineral<br>patients received maxillary sinus augmentation grafting with porcine bone mineral | Procedure: Maxillary sinus augmentation<br>* Maxillary sinus grafting with 2 different xenogenic materials<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| New bone formation | Bone trephine specimen retrieved at implant placement were histomorphometrically analyzed. With special interest % of new bone formation,% of residual graft and % of connective tissue were evaluated and compared between bovine and porcine mineral bone used for sinus grafting. | 3 year |