Biphasic Calcium Phosphate vs. Hydroxyapatite in Sinus Floor Elevation

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2015-02-23

Study Completion Date

2019-10-28

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.

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Detailed Description

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Conditions

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Bone Substitutes Calcium Phosphates Hydroxyapatite Rhodophyta Sinus Floor Augmentation

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

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SYMBIOS®

Sinus augmentation with SYMBIOS® Biphasic Bone Graft Material

Group Type EXPERIMENTAL

Use of Symbios Bone Graft Material

Intervention Type DEVICE

Patients will receive Symbios Bone Graft Material according to randomization Group.

Algipore®

Sinus augmentation with Algipore® Bone Substitution Material

Group Type ACTIVE_COMPARATOR

Algipore Bone Substitution Material

Intervention Type DEVICE

Patients will receive Algipore Bone Substitution Material according to randomization Group.

Interventions

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Use of Symbios Bone Graft Material

Patients will receive Symbios Bone Graft Material according to randomization Group.

Intervention Type DEVICE

Algipore Bone Substitution Material

Patients will receive Algipore Bone Substitution Material according to randomization Group.

Intervention Type DEVICE

Eligibility Criteria

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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

Minimum Eligible Age

20 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No