Biphasic Calcium Phosphate vs. Hydroxyapatite in Sinus Floor Elevation

Not Applicable

Completed

• Conditions: Rhodophyta; Sinus Floor Augmentation; Hydroxyapatite; Calcium Phosphates; Bone Substitutes
• Interventions: Device: Use of Symbios Bone Graft Material; Device: Algipore Bone Substitution Material

• Registration Number: NCT04331314
• Lead Sponsor: Medical University of Graz

Brief Summary

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2015-02-23
• Primary Completion: 2018-03-20
• Study Completion: 2019-10-28
• Status Verified: 2020-03
• Study First Submitted: 2020-03-31
• Study First Submitted QC: 2020-03-31
• Last Update Submitted: 2020-03-31
• Study First Posted: 2020-04-02
• Last Update Posted: 2020-04-02

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 20

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
SYMBIOS®	Use of Symbios Bone Graft Material	Sinus augmentation with SYMBIOS® Biphasic Bone Graft Material
Algipore®	Algipore Bone Substitution Material	Sinus augmentation with Algipore® Bone Substitution Material

Primary Outcome Measures

Name	Time	Method
Implant stability	12 months after sinus augmentation	measured with Periotest®

Secondary Outcome Measures

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