Maxillary Sinus Floor Augmentation With Bioss® and Enamel Matrix Derivative: Evaluation of Osteogenic Properties

Centre Hospitalier Universitaire de Nice1 site in 1 country7 target enrollmentJune 6, 2014

ConditionsPatient Who is Requiring Bilateral Sinus Floor Elevation and Necessity of Dental Surgery

Overview

Phase: Not Applicable
Intervention: Not specified
Conditions: Patient Who is Requiring Bilateral Sinus Floor Elevation and Necessity of Dental Surgery
Sponsor: Centre Hospitalier Universitaire de Nice
Enrollment: 7
Locations: 1
Primary Endpoint: Percentage of vital bone obtained within the grafted site
Status: Completed
Last Updated: 2 years ago

Overview Investigators Eligibility Criteria Outcomes Sites Similar Trials

Overview

Brief Summary

The main problem of using xenogenic bone in sinus floor elevation is the slow rate of absorption, which gives the percentages of vital bone low (20 to 30% depending on the study) in which the dental implant will be positioned However, osseointegration of the implant can be achieved only in vital bone. Enamel Matrix Derivative, through their angiogenic and osteogenic properties known, could promote bone healing during surgery sinus floor elevation by increasing the percentage of vital bone reformed, when added to xenografts.

Registry

clinicaltrials.gov

Start Date

June 6, 2014

End Date

April 12, 2017

Last Updated

2 years ago

Study Type

Interventional

Study Design

Crossover

Sex

All

Investigators

Sponsor

Centre Hospitalier Universitaire de Nice

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•Patients \> 45 years, postmenopausal women (ie with amenorrhea for more than a year).
•Subject requiring bilateral sinus floor elevation, in order to place two implants in grafted side.
•patients smoking less than 10 cigarettes per day
•patients having read and understood the information note on the study and signed the informed consent form.
•patients affiliated to the social security system.

Exclusion Criteria

•Patient with absolute contra-indication for dental surgery: valvular heart disease at risk of infectious endocarditis, recent myocardal (≤ 12 months), organ transplants, recent placement of a coronary stent (≤ 12 months), transient ischemic attacks recurrent, cardiovascular instability, uncontrolled epilepsy, rheumatic fever.
•Patient with metabolic bone disease (Paget's disease, osteomalacia, osteogenesis imperfecta)
•Patient with an ASA score ≥
•Patient with absolute contra-indication to dental surgery
•Patient with severe hematologic disease
•Patient with I or type II diabetes
•Patients with previous or current acute illness or severe chronic cardiovascular, renal, hepatic, gastrointestinal, allergic, endocrine, neuro-psychiatric, considered by the investigator to be incompatible with the conduct of the study.
•Patients treated with retinoids, oral bisphosphonates, oral anticoagulants or anticonvulsants.
•Patient have or have had cancer of the upper aerodigestive tract treated by radiotherapy.
•Patient taking a steroidal or non-steroidal anti-inflammatory, anti-cancer or immunosuppressive chemotherapy in the last 6 months.