Status:
COMPLETED
Maxillary Sinus Floor Augmentation With Bioss® and Enamel Matrix Derivative: Evaluation of Osteogenic Properties
Lead Sponsor:
Centre Hospitalier Universitaire de Nice
Conditions:
Patient Who is Requiring Bilateral Sinus Floor Elevation and Necessity of Dental Surgery
Eligibility:
All Genders
45+ years
Phase:
NA
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 i...
Eligibility Criteria
Inclusion
- 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
- 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 ≥ 3.
- 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.
- Patient monitoring considered difficult by the investigator.
- Patient with poor oral hygiene incompatible with oral surgery.
- Patients with periodontal disease unstabilized
- Patient with oral dermatitis or adverse occlusion.
- Patient with an acute or chronic infection of the surgical site (osteomyelitis).
- Patient with a known allergy to collagen
- Patient with autoimmune disease
- Patient with a linguistic or mental incapacity to understand information
- Patient younger than 45 years old
- Patient trust under curatorship or judicial protection
- Patients aged over 45 premenopausal.
- Patient participating in another clinical study.
Key Trial Info
Start Date :
June 6 2014
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 12 2017
Estimated Enrollment :
7 Patients enrolled
Trial Details
Trial ID
NCT01870960
Start Date
June 6 2014
End Date
April 12 2017
Last Update
November 14 2023
Active Locations (1)
Enter a location and click search to find clinical trials sorted by distance.
1
CHU de Nice
Nice, France, 06000