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

November 14, 2007 updated by: Baxter Healthcare Corporation

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment

86

Phase

  • Phase 2
  • Phase 3

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Erfurt, Germany, 99089
        • Klinik für Mund-, Kiefer- und Gesichtschirurgie des Helios-Klinikums Erfurt
      • Erlangen, Germany, 91054
        • Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie der Universität Erlangen-Nürnberg
      • Kiel, Germany, 24105
        • Universitatsklinikum Schleswig Holstein, Campus Kiel

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 and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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

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

  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Baxter Healthcare Corporation

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

September 1, 2004

Study Completion (Actual)

November 1, 2007

Study Registration Dates

First Submitted

September 8, 2005

First Submitted That Met QC Criteria

September 13, 2005

First Posted (Estimate)

September 14, 2005

Study Record Updates

Last Update Posted (Estimate)

November 15, 2007

Last Update Submitted That Met QC Criteria

November 14, 2007

Last Verified

November 1, 2007

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 570201

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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