Safety and Efficacy Evaluation of the Ivory Dentin Graft Device (IvoryGraft)
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ClinicalTrials.gov Identifier: NCT03150472 |
Recruitment Status :
Completed
First Posted : May 12, 2017
Last Update Posted : September 11, 2020
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Ivory Dentin Graft is at least as good as the competitor treatment group (OsteoBiol Gen Os) for alveolar ridge preservation following tooth extraction.
The non-inferiority endpoints will be achieved if the competitor treatment group will not be statistically better than the Ivory Graft treatment.
Condition or disease | Intervention/treatment | Phase |
---|---|---|
Deficiency of Alveolar Ridge (Disorder) Alveolar Bone Grafting Mandibular Prosthesis User | Device: Graft Matrix | Not Applicable |
Study Type : | Interventional (Clinical Trial) |
Actual Enrollment : | 43 participants |
Allocation: | Randomized |
Intervention Model: | Parallel Assignment |
Intervention Model Description: | The Ivory Dentin Graft study is a prospective, randomized, semi double blinded with blinded assessments study comparing patients grafted with Ivory Dentin Graft (study arm) and patients grafted with OsteoBiol Gen Os (control arm) for alveolar ridge preservation following tooth extraction. |
Masking: | Double (Participant, Outcomes Assessor) |
Masking Description: | Only the graft performing sub-investigator and the study coordinator will be un-blinded to the patient allocation. All efforts and measures would be taken by the study team to keep the patient and blinded assessors blinded of allocation (allocation of each extracted site) - semi double blinded study. Shipment tubes for biopsy (primary endpoint) are labelled with the appropriate blinded coded specimens. |
Primary Purpose: | Treatment |
Official Title: | Safety and Efficacy Evaluation of the Ivory Dentin Graft Device |
Actual Study Start Date : | November 7, 2017 |
Actual Primary Completion Date : | September 9, 2020 |
Actual Study Completion Date : | September 9, 2020 |
Arm | Intervention/treatment |
---|---|
Experimental: Ivory Dentin Graft (Ivory Graft Ltd.)
Ivory Dentin Graft is a bone graft material for the repair or augmentation of bone defects in dental procedures. It consists of sterile 300 - 1200 μm porous particles or granules of hydroxyapatite which retain the natural form of the source porcine dentin and also the natural protein matrix which consists largely of porcine collagen. This type of Graft Matrix will be administered as the intervention. |
Device: Graft Matrix
Both Graft matrix products are supplied sterile, for single use only and packed in vials or a syringe-like applicator. All products consist of the same bone graft particles with the only variants being due to different amounts per package or different containers. |
Active Comparator: OsteoBiol Gen-Os ® (Tecnoss)
A natural replicate of autologous bone, Gen-Os® conserves the same intimate structures (matrix and porous form) and presents a highly osteoconductive properties. It is biocompatible and bioavailable, as recognized by tests made according to the ISO 10993 method conducted at Eurofins Biolab. This type of Graft Matrix will be administered as the intervention. |
Device: Graft Matrix
Both Graft matrix products are supplied sterile, for single use only and packed in vials or a syringe-like applicator. All products consist of the same bone graft particles with the only variants being due to different amounts per package or different containers. |
- Amount of new bone formation [ Time Frame: 4 months after grafting ]Mean area of mineralized and non-mineralized tissue in alveolar bone core biopsies - "woven bone" (Ratio 0-100%)
- Bone-Graft material integration score to host bone in the alveolar bone core [ Time Frame: 4 months after grafting ]1 - poor: no signs of new bone-to-graft interface visible, 2 - intermediate: minimal and focal signs of new- bone-to-graft interface visible, 3 - good: abundant new bone-to-graft interface visible.
- Alveolar bone strength [ Time Frame: 4 months after grafting ]torque measurement, comparison of Ivory Dentin Graft sites with the comparator, Gen Os.
- Alveolar bone radiodensity (Hounsfield scale) [ Time Frame: 4 months after bone grafting ]calculated by volumetric CT imaging
- Success of dental implant placement in a rigid post bone grafting site [ Time Frame: 4 months after bone grafting ]defined by immediate dental implant stability
- Changes from baseline in alveolar bone height (depth reduction) [ Time Frame: 4 months after bone grafting ]measured at mesial and distal root surface [in millimetres] on Posterior to Anterior (PA) radiographs or by computer tomography (CT).
- Changes from baseline in alveolar bone width (horizontal bone gain or loss) [ Time Frame: 4 months after bone grafting ][in millimetres] on Posterior to Anterior (PA) radiographs or by computer tomography (CT)
- Usability study measures [ Time Frame: at bone grafting visit and 4 months from bone grafting ]defined by the ease of the graft/implant placement procedure (scored by the physician performing the procedure using the 10-point satisfaction scale)
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.
Ages Eligible for Study: | 18 Years to 80 Years (Adult, Older Adult) |
Sexes Eligible for Study: | All |
Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
- Male or female patient 18 up to 80 years.
- Patient requiring at least one implant placement following mandibular pre-molar or molar tooth extraction.
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Alveolar mandibular ridge (empty socket):
- Height: not less than 10 mm, from the gingival margin to the mandibular nerve canal - as seen in the screening CT scan.
- Width: not less than 5 mm, from buccal to lingual cortical plates - as seen in the screening CT scan.
- Ability to give informed consent for the study by patient or legal guardian.
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Willingness to undergo all follow up visits, as well as unscheduled sick visits.
Exclusion Criteria:
- Pregnancy (all women of child-bearing age would be questioned and told by the consenting physician regarding that criteria).
- Known or suspected hypersensitivity to the constituents of the bone graft material (for example porcine collagen)
- Pathologies or conditions contraindicating surgery or presenting with active acute or chronic infections excluding periapical granuloma (for example osteomyelitis, sinusitis), uncontrolled diabetes
- Immunologic disorders or auto-immune pathologies, in particular elderly
- Serious bone diseases of endocrine aetiology
- Serious disturbances of bone metabolism
- Ongoing treatment with gluco- or mineralocorticoids, or with agents affecting calcium metabolism (e.g. calcitonin, bisphosphonates)
- Irradiation therapy, chemotherapy or immunosuppressive therapy in the last 5 years
- Malignancies
- Severe Parafunction (bruxism and clenching)
- Poor oral hygiene or active periodontitis
- Heavy tobacco smoking habit (> 10 cigarettes per day)
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03150472
Israel | |
Assaf HaRofeh Medical Center | |
Tel Aviv, Israel, 70300 |
Study Director: | Tal Lavi, PhD | Ivory Graft Ltd. |
Responsible Party: | Ivory Graft Ltd. |
ClinicalTrials.gov Identifier: | NCT03150472 |
Other Study ID Numbers: |
QF-04-09-01P |
First Posted: | May 12, 2017 Key Record Dates |
Last Update Posted: | September 11, 2020 |
Last Verified: | September 2020 |
Individual Participant Data (IPD) Sharing Statement: | |
Plan to Share IPD: | No |
Plan Description: | IPD is not intended to be shared as this will be a single site study. The study will be public at ClinicalTrial.gov |
Studies a U.S. FDA-regulated Drug Product: | No |
Studies a U.S. FDA-regulated Device Product: | No |
Dental Instruments Dental Technology |