Safety and Efficacy Evaluation of the Ivory Dentin Graft Device (IvoryGraft) - Long Term Follow-Up

Study Overview
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Brief Summary
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long-term safety and performance of Ivory Dentin Graft. Ivory Dentin Graft is at least as good as the competitor treatment group (OsteoBiol Gen-Os) for alveolar ridge preservation following tooth extraction.

Detailed Description
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This clinical investigation is part of the post-market development process of the investigational device of Ivory Graft Ltd. in order to satisfactory validate the safety, tolerability and effectiveness of Ivory Dentin Graft as required by the sponsor's European Union (EU) notified body. The clinical Investigation was conducted with the stated confirmation applying European regulations; International Conference of Harmonization - Good Clinical Practice (ICH-GCP) guidelines, ISO 14155:2011, and with a relevant subject population for the study objectives. Israeli Ministry of Health registration Number: 20173907. The purpose of this investigation is to evaluate the safety, tolerability and effectiveness of Ivory Dentin Graft for long-term evaluations, compared to the active comparator, OsteoBiol-Gen-Os® graft, as a treatment for alveolar ridge preservation following tooth extraction. Long term follow-up: from completion of visit 5 (implant placement) up to 5 years from bone grafting per subject (visits 6-9). Study design: A prospective, randomized, semi double-blinded with blinded assessments clinical investigation, comparing between subjects grafted with Ivory Dentin Graft (Investigational group) and subjects grafted with OsteoBiol-Gen-Os® (comparator group) Study population: A total of 41 male and female adult subjects between the ages of 18 to 80 years old requiring alveolar ridge preservation that already had mandibular premolar or molar tooth extraction were included to this ongoing study (NCT03150472; short-term follow-up of 4 months following grafting was completed on September 9, 2020). Twenty-three (23) were previously randomized and grafted with Ivory Dentin Graft (Investigational group) and 18 with the active comparator, OsteoBiol Gen-Os (Comparator group). Five (5) subjects early withdrawn the short-term study resulting in 36 subjects included for this long-term study. Sample size Justification and Statistical Analysis Plan: The rationale for sample size calculation is based on demonstrating non-inferiority in the study primary endpoint between the investigational and the reference comparator groups. The calculations assume a difference of up to 30% (percent as in unit of measure and not of relative difference) woven bone between the treatments, which will be considered equivalent (non-inferiority) and standard deviation of 32%. Intended Use: bone graft material for the repair or augmentation of bone defects in dental procedures. Clinical Follow-up: subjects are medically monitored for any long-term side effects (6 and 10 months, 2.5 and 5 years following their grafting procedure) and their dental condition is also followed by dental hygienist.

Official Title
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Safety and Efficacy Evaluation of the Ivory Dentin Graft Device - Long Term Follow-Up

Conditions
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Deficiency of Alveolar Ridge (Disorder), Alveolar Bone Grafting, Mandibular Prosthesis User

Intervention / Treatment
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* Device: Ivory Dentin Graft
* Device: OsteoBiol Gen-Os


Participation Criteria
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Eligibility Criteria
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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. 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. Willingness to undergo 7 follow up visits: 1 week, 1, 4, 6 and 10 months, 2.5 years and 5 years following dental graft implantation, as well as unscheduled sick visits. Exclusion Criteria: Pregnancy (all women of childbearing 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 autoimmune 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)

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: 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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Experimental (Intervention)<br> | Device: Ivory Dentin Graft<br>* Ivory Dentin Graft is a bone graft material for the repair or augmentation of bone defects in dental procedures. It consists of sterile 300 - 900 μm porous particles or granules of hydroxyapatite and collagen which retain the natural form of the source porcine dentin and protein matrix. (Packed Vial: 1.00 gr; Packed Syringe: 1.0 gr)<br>|
| Active Comparator: Active Comparator<br> | Device: OsteoBiol Gen-Os<br>* Comparator control device A natural porcine origin cortico-cancellous heterologous bone mix consists of sterile 250 - 1000 μm porous particles of hydroxyapatite and collagen (Packed Vial: 1.0 gr)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Success of implant placement in a rigid post grafting site | defined by dental implant survival | 5 years after grafting | 
| Number of Participants with Treatment-Related Adverse Events | through study completion | 5 years after grafting | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Bone substitutes, Dental implants, Dentin