The classic website will no longer be available as of June 25, 2024. Please use the modernized ClinicalTrials.gov.
Working…
ClinicalTrials.gov
ClinicalTrials.gov Menu

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

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. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04868825
Recruitment Status : Active, not recruiting
First Posted : May 3, 2021
Last Update Posted : May 3, 2021
Sponsor:
Information provided by (Responsible Party):
Ivory Graft Ltd.

Study Description
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Deficiency of Alveolar Ridge (Disorder) Alveolar Bone Grafting Mandibular Prosthesis User Device: Ivory Dentin Graft Device: OsteoBiol Gen-Os Not Applicable

Detailed Description:

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.

Study Design
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Layout table for study information
Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 41 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention 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 (Participant, Outcomes Assessor)
Masking Description: Only the graft performing sub-investigator and the study coordinator are un-blinded to subjects allocation - semi double blinded study.
Primary Purpose: Treatment
Official Title: Safety and Efficacy Evaluation of the Ivory Dentin Graft Device - Long Term Follow-Up
Actual Study Start Date : November 7, 2017
Estimated Primary Completion Date : January 10, 2025
Estimated Study Completion Date : April 1, 2025
Arms and Interventions
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Arm Intervention/treatment
Experimental: Experimental (Intervention) Device: Ivory Dentin Graft
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)
Active Comparator: Active Comparator Device: OsteoBiol Gen-Os
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)


Outcome Measures
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

Primary Outcome Measures :
  1. Success of implant placement in a rigid post grafting site [ Time Frame: 5 years after grafting ]
    defined by dental implant survival

  2. Number of Participants with Treatment-Related Adverse Events [ Time Frame: 5 years after grafting ]
    through study completion


Eligibility Criteria
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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.


Layout table for eligibility information
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, 6 and 10 months, 2.5 years and 5 years following dental graft implantation, as well as unscheduled sick visits.

    Exclusion Criteria:

  6. Pregnancy (all women of childbearing 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 autoimmune 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)
Contacts and Locations
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information

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): NCT04868825


Locations
Layout table for location information
Israel
Assaf HaRofeh Medical Center
Zrifin, Israel, 70300
Sponsors and Collaborators
Ivory Graft Ltd.
Investigators
Layout table for investigator information
Study Director: Tal Lavi, PhD Ivory Graft Ltd.
More Information
Go to 
Top of Page Study Description Study Design Arms and Interventions Outcome Measures Eligibility Criteria Contacts and Locations More Information
Publications:

Layout table for additonal information
Responsible Party: Ivory Graft Ltd.
ClinicalTrials.gov Identifier: NCT04868825    
Other Study ID Numbers: QF-04-09-01P-
First Posted: May 3, 2021    Key Record Dates
Last Update Posted: May 3, 2021
Last Verified: April 2021
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

Layout table for additional information
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Ivory Graft Ltd.:
Bone substitutes
Dental implants
Dentin