Biphasic Calcium Phosphate vs. Hydroxyapatite in Sinus Floor Elevation

Medical University of Graz

Status: Completed

Conditions: Calcium Phosphates; Sinus Floor Augmentation; Rhodophyta; Bone Substitutes; Hydroxyapatite

Treatments: Device: Use of Symbios Bone Graft Material; Device: Algipore Bone Substitution Material

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT04331314

27-224 ex 14/15

Details and patient eligibility

About

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.

Enrollment: 20 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups

SYMBIOS®

Experimental group

Description:

Sinus augmentation with SYMBIOS® Biphasic Bone Graft Material

Treatment:

Device: Use of Symbios Bone Graft Material

Algipore®

Active Comparator group

Description:

Sinus augmentation with Algipore® Bone Substitution Material

Treatment:

Device: Algipore Bone Substitution Material