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

Primary Purpose

Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone Height

Status

Unknown status

Phase

Not Applicable

Locations

Study Type

Interventional

Intervention

Alpha-Bio's GRAFT Natural Bovine Bone

Bio-Oss xenograft

About this trial

This is an interventional treatment trial for Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone Height

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

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

Exclusion Criteria:

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

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Arm Label

Alpha-Bio's GRAFT Natural Bovine Bone

Bio-Oss xenograft

Arm Description

two different bone substitutes commonly used in dental procedures.

Outcomes

Primary Outcome Measures

Uneventful healing and histological bone formation

Secondary Outcome Measures

X-ray demonstration of volume - stable results

Equally high implant survival rates and crestal bone loss

Full Information

NCT ID

NCT01781221

First Posted

January 10, 2013

Last Updated

January 29, 2013

Sponsor

University Hospital of Cologne

1. Study Identification

Unique Protocol Identification Number

NCT01781221

Brief Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

January 2013

Overall Recruitment Status

Unknown status

Study Start Date

February 2013 (undefined)

Primary Completion Date

January 2018 (Anticipated)

Study Completion Date

undefined (undefined)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

University Hospital of Cologne

4. Oversight

5. Study Description

Brief Summary

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

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Posterior Maxilla Edentulous Patients With Insufficient Alveolar Bone Height

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

Participant

Allocation

Randomized

Enrollment

44 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

Alpha-Bio's GRAFT Natural Bovine Bone

Arm Type

Active Comparator

Arm Description

two different bone substitutes commonly used in dental procedures.

Arm Title

Bio-Oss xenograft

Arm Type

Active Comparator

Arm Description

two different bone substitutes commonly used in dental procedures.

Intervention Type

Device

Intervention Name(s)

Alpha-Bio's GRAFT Natural Bovine Bone

Intervention Type

Device

Intervention Name(s)

Bio-Oss xenograft

Primary Outcome Measure Information:

Title

Uneventful healing and histological bone formation

Time Frame

6 months following sinus floor augmentation

Secondary Outcome Measure Information:

Title

X-ray demonstration of volume - stable results

Time Frame

6 months following augmentation procedures.

Title

Equally high implant survival rates and crestal bone loss

Time Frame

After 1,2 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Maximum Age & Unit of Time

80 Years

Accepts Healthy Volunteers

Eligibility Criteria

Inclusion Criteria: Patients who will present with a moderately or severely atrophic posterior maxilla with 1-6 mm residual alveolar bone . Men and women over the age of 18 years. Patient has signed the Informed Consent. Exclusion Criteria: Chronic steroid therapy. Uncontrolled diabetes. Cardiovascular disease. Past irradiation of head and neck. Maxillary sinus cysts. Active chronic sinusitis. Smoking more than ten cigarettes per day during the 3 months preceding this study . Malignant disease in the 5 years preceding this study. Uncontrolled bleeding disorders such as: hemophilia, thrombocytopenia, granulocytopenia Disease that compromise the immune system Psychiatric disorder Hypersensitivity to titanium, collagen or bovine bone. Women who are pregnant or nursing. Patients with non-treated periodontal disease. Medical and/or general contraindications for intraoral surgical procedures.

12. IPD Sharing Statement

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

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