Biphasic Calcium Phosphate vs. Hydroxyapatite in Sinus Floor Elevation

Study Overview
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Brief Summary
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Twenty patients scheduled for lateral-window sinus floor Elevation (SFE) are randomized into two groups: use of SYMBIOS® Biphasic Bone Graft Material (Group 1) or of Algipore® Bone Substitution Material (Group 2). Biopsies are taken 3 months after SFE and during implant surgery after 6 months. One ground section per biopsy (n=40) is stained, scanned, and histomorphometrically analyzed for new bone, old bone, soft tissue, graft, bone infiltration of graft, bone-to-graft contact, and penetration depth.

Official Title
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Sinus Augmentation Using Symbios Versus Algipore as Bone Graft Material - A Randomized Controlled Clinical Pilot Study

Conditions
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Bone Substitutes, Calcium Phosphates, Hydroxyapatite, Rhodophyta, Sinus Floor Augmentation

Intervention / Treatment
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* Device: Use of Symbios Bone Graft Material
* Device: Algipore Bone Substitution Material


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Capability of giving an informed consent Good health as defined by the subject's medical history Patients age 20-75 years Fully edentulous or partially edentulous patients with unilateral or bilateral missing teeth in the maxillary premolar or molar areas with severe alveolar atrophy and a residual alveolar ridge height of maximal 5 mm requiring a two-staged sinus floor elevation and implant placement. Exclusion Criteria: Patients without detailed baseline medical data Patients with medical history of local inflammations in the posterior maxilla Skeletal immaturity Patients with osteoporosis in their medical history Patients with severe illnesses, malignant diseases, radiotherapy or chemotherapy in their medical history Patients with pathological fractures Patients treated with bisphosphonates Uncontrolled diabetes mellitus Uncontrolled periodontal diseases Smoking Pregnancy

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

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: Twenty patients scheduled for lateral-window sinus floor Elevation SFE will be randomized to an HA and a β-TCP/HA Group.
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: SYMBIOS®<br>Sinus augmentation with SYMBIOS® Biphasic Bone Graft Material | Device: Use of Symbios Bone Graft Material<br>* Patients will receive Symbios Bone Graft Material according to randomization Group.<br>|
| Active Comparator: Algipore®<br>Sinus augmentation with Algipore® Bone Substitution Material | Device: Algipore Bone Substitution Material<br>* Patients will receive Algipore Bone Substitution Material according to randomization Group.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Implant stability | measured with Periotest® | 12 months after sinus augmentation | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Survival rate of the implants | Rate of loss of implants | 24 months after sinus augmentation | 
| Probing on depth | The measurement of probing depth will be performed with a CPITN probe with 0.5mm ball head | 24 months after sinus augmentation | 
| Bleeding on probing |  | 24 months | 
| Crestal bone level after implant | measured by means of single tooth x-rays | 12 months after implant placement | 
| Complications | Frequency of complications | 6 months after sinus augmentation | 
| Newly formed bone area in mm² | measured through histomorphological analysis | 3 months after sinus augmentation | 
| Newly formed bone area in mm² | measured through histomorphological analysis | 6 months after sinus augmentation | 
| Old bone area in mm² | measured through histomorphological analysis | 3 months after sinus augmentation | 
| Old bone area in mm² | measured through histomorphological analysis | 6 months after sinus augmentation | 
| Tissue area in mm² | measured through histomorphological analysis | 3 months after sinus augmentation | 
| Tissue area in mm² | measured through histomorphological analysis | 6 months after sinus augmentation | 
| Bone substitute area in mm² | measured through histomorphological analysis | 3 months after sinus augmentation | 
| Bone substitute area in mm² | measured through histomorphological analysis | 6 months after sinus augmentation | 
| New bone infiltration area in bone substitute in mm² | measured through histomorphological analysis | 3 months after sinus augmentation | 
| New bone infiltration area in bone substitute in mm² | measured through histomorphological analysis | 6 months after sinus augmentation | 
| new bone to bone substitute contact in mm | measured through histomorphological analysis | 6 months after sinus augmentation | 
| Penetration depth in mm | measured through histomorphological analysis | 3 months after sinus augmentation | 
| Penetration depth in mm | measured through histomorphological analysis | 6 months after sinus augmentation |