- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01781221
Sinus Floor Elevation Using Separately Two Different Xenografts - A Prospective Randomized Clinical Trial
January 29, 2013 updated by: University Hospital of Cologne
The purpose of this study is to compare the regenerative results of using separately two different xenografts after two-step sinus floor elevation.
Study Overview
Status
Unknown
Intervention / Treatment
Study Type
Interventional
Enrollment (Anticipated)
44
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
18 years to 80 years (Adult, Older Adult)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Active Comparator: Alpha-Bio's GRAFT Natural Bovine Bone
two different bone substitutes commonly used in dental procedures.
|
|
Active Comparator: Bio-Oss xenograft
two different bone substitutes commonly used in dental procedures.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
Uneventful healing and histological bone formation
Time Frame: 6 months following sinus floor augmentation
|
6 months following sinus floor augmentation
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
X-ray demonstration of volume - stable results
Time Frame: 6 months following augmentation procedures.
|
6 months following augmentation procedures.
|
Equally high implant survival rates and crestal bone loss
Time Frame: After 1,2 years
|
After 1,2 years
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
February 1, 2013
Primary Completion (Anticipated)
January 1, 2018
Study Registration Dates
First Submitted
January 10, 2013
First Submitted That Met QC Criteria
January 29, 2013
First Posted (Estimate)
January 31, 2013
Study Record Updates
Last Update Posted (Estimate)
January 31, 2013
Last Update Submitted That Met QC Criteria
January 29, 2013
Last Verified
January 1, 2013
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 12-200
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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