Performance and Safety of Bone Substitute MBCP-FS in Maxillary Sinus Lift Procedures

This study has been completed.
Sponsor:
Information provided by:
Baxter Healthcare Corporation
ClinicalTrials.gov Identifier:
NCT00163605
First received: September 8, 2005
Last updated: November 14, 2007
Last verified: November 2007
  Purpose

The purpose of this study is to evaluate the performance and to monitor the safety of the bone substitute Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS) in Sinus Lift Procedures . This study will be conducted in two parts: part A evaluates safety and performance of MBCP-FS in bone regeneration i.e. the amount of new bone that is formed and its suitability for dental implant placement. Part B is designed to evaluate long-term safety and performance of the product, i.e. whether the newly-formed bone is suitable to retain implants.


Condition Intervention Phase
Sinus Implant Reconstruction
Device: Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS)
Phase 2
Phase 3

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Official Title: A Prospective Clinical Study to Evaluate the Performance and Safety of the Bone Substitute MBCP-FS in Maxillary Sinus Lift Procedures

Resource links provided by NLM:


Further study details as provided by Baxter Healthcare Corporation:

Estimated Enrollment: 86
Study Start Date: September 2004
Study Completion Date: November 2007
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion criteria:

  • Written informed consent obtained from the subject prior to participation in the study
  • At least 18 years of age
  • Partially or totally edentulous with an atrophic posterior maxilla requiring unilateral or bilateral sinus lift before dental implant placement
  • In case of bilateral sinus lifts, both sides are operated on the same day.
  • Subjects with remaining minimal maxillary bone height between 2 mm and 5 mm at the site with minimal height in the area where implants are planned, and a remaining maxillary bone thickness >= 5 mm in the area where implants are planned

Exclusion Criteria:

  • Previous or coeval major surgical intervention in the targeted area, or major surgical intervention in the targeted area planned within the next 18 months (like Caldwell Luc) (minor interventions like surgical tooth extraction or root tip resections are allowed)
  • Surgical tooth extraction in the targeted area less than three months before the SLP
  • Maxillary and sinus disorders including: acute sinusitis, chronic sinus pathology, retained root tips, polyps, tumors, and cysts in antral cavity or odontogenic cysts, alveolar scar ablation
  • Major occlusal disturbance, like severe bruxism
  • Uncontrolled* periodontal disease
  • An inadequate interarch distance requiring an oppositional graft
  • Immune system disorders, immunodeficiency or immunosuppression
  • Known coagulation disorder
  • Uncontrolled* diabetes mellitus
  • Severe hyperparathyroidism
  • Receiving long-term anti-inflammatory treatment with NSAIDs or corticosteroids
  • Chemotherapy current or in the last three months
  • Having undergone maxillary radiation therapy
  • Known hypersensitivity to aprotinin or to other components of the investigational product
  • Abuse of alcohol or drugs or tobacco consumption of more than 5 cigarettes per day at study start
  • Non-compliant for future dental hygiene
  • Severely compromised physical and psychological health, that in the investigators opinion will affect patient compliance
  • Any contra-indications to the use of MBCP, which are defined as osteomyelitis, degenerative bone disease or necrosis of the recipient site
  • Concurrently participating in another clinical trial and having received another investigational drug or device within the last 30 days
  • Pregnant or lactating, or intending to become pregnant during the study period

    • Uncontrolled = not treated or not stabilized after treatment
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00163605

Locations
Germany
Klinik für Mund-, Kiefer- und Gesichtschirurgie des Helios-Klinikums Erfurt
Erfurt, Germany, 99089
Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie der Universität Erlangen-Nürnberg
Erlangen, Germany, 91054
Universitätsklinikum Schleswig Holstein, Campus Kiel
Kiel, Germany, 24105
Sponsors and Collaborators
Baxter Healthcare Corporation
Investigators
Principal Investigator: Baxter BioScience Investigator Baxter BioScience
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00163605     History of Changes
Other Study ID Numbers: 570201
Study First Received: September 8, 2005
Last Updated: November 14, 2007
Health Authority: Germany: Paul-Ehrlich-Institut

Keywords provided by Baxter Healthcare Corporation:
Sinus augmentation
Alloplastic bone substitute
Hydroxyl apatite

Additional relevant MeSH terms:
Fibrin Tissue Adhesive
Hemostatics
Coagulants
Hematologic Agents
Therapeutic Uses
Pharmacologic Actions

ClinicalTrials.gov processed this record on July 31, 2014