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

Conditions

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:

  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.

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.
Device: Alpha-Bio's GRAFT Natural Bovine Bone
Active Comparator: Bio-Oss xenograft
two different bone substitutes commonly used in dental procedures.
Device: Bio-Oss xenograft

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

University Hospital of Cologne

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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