ClinicalTrials.gov
ClinicalTrials.gov Menu

Safety and Efficacy Evaluation of the Ivory Dentin Graft Device (IvoryGraft)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03150472
Recruitment Status : Recruiting
First Posted : May 12, 2017
Last Update Posted : July 27, 2018
Sponsor:
Information provided by (Responsible Party):
Ivory Graft Ltd.

Brief Summary:

Ivory Dentin Graft is at least as good as the reference test device (OsteoBiol Gen Os) for alveolar ridge preservation following tooth extraction.

The null hypothesis is that Ivory Dentin Graft and OsteoBiol Gen Os are not equivalent (Gen Os is better than Ivory Dentin Graft) and the alternative hypothesis is that the proportions in the two groups are equivalent, assuming that the expected difference in proportions is 0.0 (Ivory Dentin Graft is as good as Gen Os Graft).


Condition or disease Intervention/treatment Phase
Deficiency of Alveolar Ridge (Disorder) Alveolar Bone Grafting Mandibular Prosthesis User Device: Graft Matrix Not Applicable

  Show Detailed Description

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 44 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
Estimated Primary Completion Date : April 2019
Estimated Study Completion Date : April 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Bone Grafts

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.




Primary Outcome Measures :
  1. Amount of new bone formation [ Time Frame: 4 months after grafting ]
    Mean area of mineralized tissue (#bone plates) - host bone ingrowth and persisting graft material particles) in the alveolar bone core biopsies.

  2. Bone-Graft material integration to host bone [ Time Frame: 4 months after grafting ]
    Bone-Graft material integration to host bone (optional: close apposition of the graft particles - the sum of the host and graft bone area (mineralized tissue) and the host-bone to bone-graft particle contact) in the alveolar bone core biopsies.


Secondary Outcome Measures :
  1. Alveolar bone strength [ Time Frame: 4 months after grafting ]
    torque measurement, comparison of Ivory Dentin Graft sites with the comparator, Gen Os.

  2. Alveolar bone density [ Time Frame: 4 months after bone grafting ]
    measured in the alveolar bone core biopsies (mean distance between the cell nuclei), comparison of Ivory Dentin Graft sites with the comparator, Gen Os.

  3. 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

  4. 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).

  5. 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)

  6. Success of implant placement in a rigid post grafting site [ Time Frame: after 5 years from grafting (visit 8). ]
    defined by dental implant survival


Other Outcome Measures:
  1. Usability study measures [ Time Frame: Upto 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)



Information from the National Library of Medicine

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
Criteria

Inclusion Criteria:

  1. Male or female patient 18 up to 80 years.
  2. Patient requiring at least one implant placement following mandibular pre-molar or molar tooth extraction.
  3. 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.
  4. Ability to give informed consent for the study by patient or legal guardian.
  5. Willingness to undergo 7 follow up visits: 1 week, 1, 4 and 6 months, 1 year, 2.5 years and 5 years following dental graft implantation, as well as unscheduled sick visits.

    Exclusion Criteria:

  6. Pregnancy (all women of child-bearing age would be questioned and told by the consenting physician regarding that criteria).
  7. Known or suspected hypersensitivity to the constituents of the bone graft material (for example porcine collagen)
  8. Pathologies or conditions contraindicating surgery or presenting with active acute or chronic infections excluding periapical granuloma (for example osteomyelitis, sinusitis), uncontrolled diabetes
  9. Immunologic disorders or auto-immune pathologies, in particular elderly
  10. Serious bone diseases of endocrine aetiology
  11. Serious disturbances of bone metabolism
  12. Ongoing treatment with gluco- or mineralocorticoids, or with agents affecting calcium metabolism (e.g. calcitonin, bisphosphonates)
  13. Irradiation therapy, chemotherapy or immunosuppressive therapy in the last 5 years
  14. Malignancies
  15. Severe Parafunction (bruxism and clenching)
  16. Poor oral hygiene or active periodontitis
  17. Heavy tobacco smoking habit (> 10 cigarettes per day)

Information from the National Library of Medicine

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


Contacts
Contact: Tal Lavi, PhD 972-52-7465388 tal@gsap.co.il
Contact: Lari Sapoznikov, MD 972-50-6593764 lari.sapoznikov@gmail.com

Locations
Israel
Assaf HaRofeh Medical Center Recruiting
Tel Aviv, Israel, 70300
Contact: Shai Efrati, MD    972-8-9779395    efratishai@013.net   
Contact: Roy Sagi, RN    972-8-9778060    roysagi@bezeqint.net   
Sponsors and Collaborators
Ivory Graft Ltd.
Investigators
Study Director: Tal Lavi, PhD GSAP Medical Ltd.

Publications:
Responsible Party: Ivory Graft Ltd.
ClinicalTrials.gov Identifier: NCT03150472     History of Changes
Other Study ID Numbers: QF-04-09-01P
First Posted: May 12, 2017    Key Record Dates
Last Update Posted: July 27, 2018
Last Verified: November 2017
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

Keywords provided by Ivory Graft Ltd.:
Dental Instruments
Dental Technology