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Sinus Floor Elevation Using Separately Two Different Xenografts - A Prospective Randomized Clinical Trial

NCT ID: NCT01781221

Last Updated: 2013-01-31

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

UNKNOWN

Clinical Phase

NA

Total Enrollment

44 participants

Study Classification

INTERVENTIONAL

Study Start Date

2013-02-28

Brief Summary

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The purpose of this study is to compare the regenerative results of using separately two different xenografts after two-step sinus floor elevation.

Detailed Description

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Conditions

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Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone Height

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

SINGLE

Participants

Study Groups

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Alpha-Bio's GRAFT Natural Bovine Bone

two different bone substitutes commonly used in dental procedures.

Group Type ACTIVE_COMPARATOR

Alpha-Bio's GRAFT Natural Bovine Bone

Intervention Type DEVICE

Bio-Oss xenograft

two different bone substitutes commonly used in dental procedures.

Group Type ACTIVE_COMPARATOR

Bio-Oss xenograft

Intervention Type DEVICE

Interventions

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Alpha-Bio's GRAFT Natural Bovine Bone

Intervention Type DEVICE

Bio-Oss xenograft

Intervention Type DEVICE

Eligibility Criteria

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Inclusion Criteria

1. Patients who will present with a moderately or severely atrophic posterior maxilla with 1-6 mm residual alveolar bone .
2. Men and women over the age of 18 years.
3. Patient has signed the Informed Consent.

Exclusion Criteria

1. Chronic steroid therapy.
2. Uncontrolled diabetes.
3. Cardiovascular disease.
4. Past irradiation of head and neck.
5. Maxillary sinus cysts.
6. Active chronic sinusitis.
7. Smoking more than ten cigarettes per day during the 3 months preceding this study .
8. Malignant disease in the 5 years preceding this study.
9. Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia
10. Disease that compromise the immune system
11. Psychiatric disorder
12. Hypersensitivity to titanium, collagen or bovine bone.
13. Women who are pregnant or nursing.
14. Patients with non-treated periodontal disease.
15. Medical and/or general contraindications for intraoral surgical procedures.
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital of Cologne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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12-200

Identifier Type: -

Identifier Source: org_study_id