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

September 8, 2005
November 14, 2007
September 2004
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Complete list of historical versions of study NCT00163605 on ClinicalTrials.gov Archive Site
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Performance and Safety of Bone Substitute MBCP-FS in Maxillary Sinus Lift Procedures
A Prospective Clinical Study to Evaluate the Performance and Safety of the Bone Substitute MBCP-FS in Maxillary Sinus Lift Procedures

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.

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Interventional
Phase 2
Phase 3
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Sinus Implant Reconstruction
Device: Macroporous Biphasic Calcium Phosphate-Fibrin Sealant Vapor Heated Solvent/Detergent Treated 4 IU/ML Thrombin (MBCP-FS)
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*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
86
November 2007
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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
Both
18 Years and older
Yes
Contact information is only displayed when the study is recruiting subjects
Germany
 
NCT00163605
570201
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Baxter Healthcare Corporation
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Principal Investigator: Baxter BioScience Investigator Baxter BioScience
Baxter Healthcare Corporation
November 2007

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP