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

Sponsor

Baxter Healthcare Corporation (Industry)

Overall Status

Completed

CT.gov ID

NCT00163605

Collaborator

(none)

Enrollment

Locations

Duration (Months)

28.7

Patients Per Site

0.8

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

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 or Disease	Intervention/Treatment	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 Design

Study Type:

Interventional

Allocation:

Non-Randomized

Intervention Model:

Parallel Assignment

Masking:

None (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

Study Start Date :

Sep 1, 2004

Actual Study Completion Date :

Nov 1, 2007

Outcome Measures

Primary Outcome Measures

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Yes

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

Locations

	Site	City	Country	Postal Code
1	Klinik für Mund-, Kiefer- und Gesichtschirurgie des Helios-Klinikums Erfurt	Erfurt	Germany	99089
2	Klinik und Poliklinik für Mund-, Kiefer- und Gesichtschirurgie der Universität Erlangen-Nürnberg	Erlangen	Germany	91054
3	Universitätsklinikum Schleswig Holstein, Campus Kiel	Kiel	Germany	24105