Biphasic Calcium Phosphate vs. Hydroxyapatite in Sinus Floor Elevation

Medical University of Graz20 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

Conditions

Bone Substitutes Calcium Phosphates Hydroxyapatite Rhodophyta Sinus Floor Augmentation

Eligibility

Sex: ALLMin age: 20 YearsMax age: 75 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Capability of giving an informed consent 2. Good health as defined by the subject's medical history 3. Patients age 20-75 years 4. 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: 1. Patients without detailed baseline medical data 2. Patients with medical history of local inflammations in the posterior maxilla 3. Skeletal immaturity 4. Patients with osteoporosis in their medical history 5. Patients with severe illnesses, malignant diseases, radiotherapy or chemotherapy in their medical history 6. Patients with pathological fractures 7. Patients treated with bisphosphonates 8. Uncontrolled diabetes mellitus 9. Uncontrolled periodontal diseases 10. Smoking 11. Pregnancy

Outcomes

Primary Outcomes

Implant stability

measured with Periotest®

Time frame: 12 months after sinus augmentation

Secondary Outcomes

Survival rate of the implants

Rate of loss of implants

Time frame: 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

Time frame: 24 months after sinus augmentation

Bleeding on probing

Time frame: 24 months

Crestal bone level after implant

measured by means of single tooth x-rays

Time frame: 12 months after implant placement

Complications

Frequency of complications

Time frame: 6 months after sinus augmentation

Newly formed bone area in mm²