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

NCT04868825 | Unknown

• 1 other identifier: QF-04-09-01P-
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

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.

Conditions

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

Keywords

Bone substitutes; Dental implants; Dentin

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (2)

Experimental (Intervention)

EXPERIMENTAL

Device: Ivory Dentin Graft

Active Comparator

ACTIVE COMPARATOR

Device: OsteoBiol Gen-Os

Interventions

Ivory Dentin Graft DEVICE

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)

Experimental (Intervention)

OsteoBiol Gen-Os DEVICE

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)

Active Comparator

Eligibility Criteria

• Age: 18 Years - 80 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ivory Graft Ltd.: lead

Study Sites (1)

Assaf HaRofeh Medical Center

Zrifin, 70300, Israel

Location

Related Publications (12)

• Hansson S, Halldin A. Alveolar ridge resorption after tooth extraction: A consequence of a fundamental principle of bone physiology. J Dent Biomech. 2012;3:1758736012456543. doi: 10.1177/1758736012456543. Epub 2012 Aug 16.

  PMID: 22924065 BACKGROUND

• Horowitz R, Holtzclaw D, Rosen PS. A review on alveolar ridge preservation following tooth extraction. J Evid Based Dent Pract. 2012 Sep;12(3 Suppl):149-60. doi: 10.1016/S1532-3382(12)70029-5.

  PMID: 23040345 BACKGROUND

• Avila-Ortiz G, Chambrone L, Vignoletti F. Effect of alveolar ridge preservation interventions following tooth extraction: A systematic review and meta-analysis. J Clin Periodontol. 2019 Jun;46 Suppl 21:195-223. doi: 10.1111/jcpe.13057. Erratum In: J Clin Periodontol. 2020 Jan;47(1):129. doi: 10.1111/jcpe.13212.

  PMID: 30623987 BACKGROUND

• Chrcanovic BR, Albrektsson T, Wennerberg A. Bone Quality and Quantity and Dental Implant Failure: A Systematic Review and Meta-analysis. Int J Prosthodont. 2017 May/June;30(3):219-237. doi: 10.11607/ijp.5142. Epub 2017 Mar 20.

  PMID: 28319206 BACKGROUND

• Herrmann I, Lekholm U, Holm S, Kultje C. Evaluation of patient and implant characteristics as potential prognostic factors for oral implant failures. Int J Oral Maxillofac Implants. 2005 Mar-Apr;20(2):220-30.

  PMID: 15839115 BACKGROUND

• Barone A, Todisco M, Ludovichetti M, Gualini F, Aggstaller H, Torres-Lagares D, Rohrer MD, Prasad HS, Kenealy JN. A prospective, randomized, controlled, multicenter evaluation of extraction socket preservation comparing two bovine xenografts: clinical and histologic outcomes. Int J Periodontics Restorative Dent. 2013 Nov-Dec;33(6):795-802. doi: 10.11607/prd.1690.

  PMID: 24116363 BACKGROUND

• Mahesh L, Venkataraman N, Shukla S, Prasad H, Kotsakis GA. Alveolar ridge preservation with the socket-plug technique utilizing an alloplastic putty bone substitute or a particulate xenograft: a histological pilot study. J Oral Implantol. 2015 Apr;41(2):178-83. doi: 10.1563/AAID-JOI-D-13-00025. Epub 2013 Jun 17.

  PMID: 23772806 BACKGROUND

• Lai VJ, Michalek JE, Liu Q, Mealey BL. Ridge preservation following tooth extraction using bovine xenograft compared with porcine xenograft: A randomized controlled clinical trial. J Periodontol. 2020 Mar;91(3):361-368. doi: 10.1002/JPER.19-0211. Epub 2019 Aug 23.

  PMID: 31380563 BACKGROUND

• Pang C, Ding Y, Zhou H, Qin R, Hou R, Zhang G, Hu K. Alveolar ridge preservation with deproteinized bovine bone graft and collagen membrane and delayed implants. J Craniofac Surg. 2014 Sep;25(5):1698-702. doi: 10.1097/SCS.0000000000000887.

  PMID: 25148644 BACKGROUND

• Jung RE, Sapata VM, Hammerle CHF, Wu H, Hu XL, Lin Y. Combined use of xenogeneic bone substitute material covered with a native bilayer collagen membrane for alveolar ridge preservation: A randomized controlled clinical trial. Clin Oral Implants Res. 2018 May;29(5):522-529. doi: 10.1111/clr.13149. Epub 2018 Apr 1.

  PMID: 29607553 BACKGROUND

• Meloni SM, Tallarico M, Lolli FM, Deledda A, Pisano M, Jovanovic SA. Postextraction socket preservation using epithelial connective tissue graft vs porcine collagen matrix. 1-year results of a randomised controlled trial. Eur J Oral Implantol. 2015 Spring;8(1):39-48.

  PMID: 25738178 BACKGROUND

• Lee JS, Cha JK, Kim CS. Alveolar ridge regeneration of damaged extraction sockets using deproteinized porcine versus bovine bone minerals: A randomized clinical trial. Clin Implant Dent Relat Res. 2018 Oct;20(5):729-737. doi: 10.1111/cid.12628. Epub 2018 Jul 27.

  PMID: 30051954 BACKGROUND

Study Officials

• Tal Lavi, PhD

  Ivory Graft Ltd.

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, OUTCOMES ASSESSOR
• Masking Details: Only the graft performing sub-investigator and the study coordinator are un-blinded to subjects allocation - semi double blinded study.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: April 20, 2021
• First Posted: May 3, 2021
• Study Start: November 7, 2017
• Primary Completion: January 10, 2025
• Study Completion: April 1, 2025
• Last Updated: May 3, 2021

Record last verified: 2021-04

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)