Jaw, Edentulous, Jaw, Edentulous, Partially
Conditions
Keywords
Guided Tissue Regeneration, Dental Implants, Membrane, Synthetic
Brief summary
The purpose of this study is to examine the safety and usefulness of the Regenecure guided bone regeneration membrane for stimulating bone growth in patients that don't have enough bone for dental implant placement. The study will include 16 patients in each group, 20 non-smokers and 12 smokers, a total of 32 patients will participate in the study.
Interventions
DEVICERegenecure AMCA GBR Dental Membrane
Patients will undergo Guided Bone Regeneration (GBR) procedure using the Regenecure AMCA GBR Membrane
DEVICEGeistlich Bio-Gide® collagen membrane
The Geistlich Bio-Gide® collagen membrane, a commercially available product, will be used in 10 patients.
Sponsors
RegeneCure, Ltd.
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 65 Years
Healthy volunteers
No
Inclusion criteria
* Subject must have voluntarily signed the informed consent form before any study related action * Age: 18 to 65 with missing teeth, seeking for implant therapy. * Men/Women * In good systemic health * Present with no contra indication against oral surgical interventions * Single/ multiple tooth gap - have at least one missing tooth in the mandible or maxilla, requiring one or more dental implants. * The tooth at the implant site(s) must have been extracted or lost at least 6 weeks before the date of implantation. * Bone defect(s) must be present with a lateral dimension greater than or equal to 5 mm or less. * Full mouth plaque score (FMPI) lower or equal than 25% * Patients must be committed to the study
Exclusion criteria
* Medical conditions requiring prolonged use of steroids * Use of Bisphosphonate intravenously * Current pregnancy or breastfeeding women * Alcoholism or chronically drug abuse * Immunocompromised patients * Uncontrolled Diabetes * Conditions or circumstances, in the opinion of the investigator, which would prevent completion of study participation or interfere with analysis of study results, such as history of non-compliance, or unreliability. * Untreated inflammation * Mucosal diseases or oral lesions * History of local irradiation therapy * Persistent intraoral infection * Patients with bad oral hygiene or unmotivated for normal home care.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Bone volume | Change from Baseline in bone volume at 6 months | Clinical effect on bone volume measured using CBCT. The volume of the newly formed bone will be evaluated by subtraction of the 2 cone beam CTs using digital measurements. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Histomorphometry | 6 months | Specimens will be prepared for histological staining (H&E and Masson's trichrome stain). The stained samples will be evaluated for new bone, residual bone graft, marrow spaces and vascularity. |
| Safety will be demonstrated by using VAS scale for pain measurements and if the PI will consider that any adverse event device related isn't clinically significant | six months | Safety will be demonstrated by using VAS scale for pain measurements and if the PI will consider that any adverse event device related isn't clinically significant |
Countries
Israel
Contacts
Primary ContactMichal Limor, MD
Outcome results
None listed