Safety and Efficacy Evaluation of the Ivory Dentin Graft Device

NCT03150472 | Completed

• 1 other identifier: QF-04-09-01P
• Study Type: interventional
• Target: 43
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

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

Keywords

Dental Instruments; Dental Technology

Outcome Measures

Primary Outcomes (2)

• Amount of new bone formation

  Mean area of mineralized and non-mineralized tissue in alveolar bone core biopsies - "woven bone" (Ratio 0-100%)

  4 months after grafting

• Bone-Graft material integration score to host bone in the alveolar bone core

  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.

  4 months after grafting

Secondary Outcomes (5)

• Alveolar bone strength

  4 months after grafting

• Alveolar bone radiodensity (Hounsfield scale)

  4 months after bone grafting

• Success of dental implant placement in a rigid post bone grafting site

  4 months after bone grafting

• Changes from baseline in alveolar bone height (depth reduction)

  4 months after bone grafting

• Changes from baseline in alveolar bone width (horizontal bone gain or loss)

  4 months after bone grafting

Other Outcomes (1)

• Usability study measures

  at bone grafting visit and 4 months from bone grafting

Study Arms (2)

Ivory Dentin Graft (Ivory Graft Ltd.)

EXPERIMENTAL

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

OsteoBiol Gen-Os ® (Tecnoss)

ACTIVE COMPARATOR

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

Interventions

Graft Matrix DEVICE

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.

Ivory Dentin Graft (Ivory Graft Ltd.); OsteoBiol Gen-Os ® (Tecnoss)

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 all follow up visits, as well as unscheduled sick visits.

You may not qualify if:

• 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)

Sponsors & Collaborators

• Ivory Graft Ltd.: lead

Study Sites (1)

Assaf HaRofeh Medical Center

Tel Aviv, 70300, Israel

Location

Related Publications (7)

• Abraham CM. A brief historical perspective on dental implants, their surface coatings and treatments. Open Dent J. 2014 May 16;8:50-5. doi: 10.2174/1874210601408010050. eCollection 2014.

  PMID: 24894638 BACKGROUND

• Atieh MA, Alsabeeha NH, Payne AG, Duncan W, Faggion CM, Esposito M. Interventions for replacing missing teeth: alveolar ridge preservation techniques for dental implant site development. Cochrane Database Syst Rev. 2015 May 28;2015(5):CD010176. doi: 10.1002/14651858.CD010176.pub2.

  PMID: 26020735 BACKGROUND

• Binderman I, Hallel G, Nardy C, Yaffe A, Sapoznikov L. A novel procedure to process extracted teeth for immediate grafting of autogenous dentin. J Interdiscipl Med Dent Sci, 2014; 2(6). http://dx.doi.org/10.4172/jimds.1000154

  BACKGROUND

• Campbell KM, Casas MJ, Kenny DJ. Ankylosis of traumatized permanent incisors: pathogenesis and current approaches to diagnosis and management. J Can Dent Assoc. 2005 Nov;71(10):763-8.

  PMID: 16324230 BACKGROUND

• Nguyen TT, Mui B, Mehrabzadeh M, Chea Y, Chaudhry Z, Chaudhry K, Tran SD. Regeneration of tissues of the oral complex: current clinical trends and research advances. J Can Dent Assoc. 2013;79:d1.

  PMID: 23522126 BACKGROUND

• Patel K, Mardas N, Donos N. Radiographic and clinical outcomes of implants placed in ridge preserved sites: a 12-month post-loading follow-up. Clin Oral Implants Res. 2013 Jun;24(6):599-605. doi: 10.1111/j.1600-0501.2012.02500.x. Epub 2012 Jun 3.

  PMID: 22672611 BACKGROUND

• Sapoznikov L, Haim D, Zavan B, Scortecci G, Humphrey MF. A novel porcine dentin-derived bone graft material provides effective site stability for implant placement after tooth extraction: a randomized controlled clinical trial. Clin Oral Investig. 2023 Jun;27(6):2899-2911. doi: 10.1007/s00784-023-04888-5. Epub 2023 Feb 24.

  PMID: 36826514 DERIVED

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 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: May 8, 2017
• First Posted: May 12, 2017
• Study Start: November 7, 2017
• Primary Completion: September 9, 2020
• Study Completion: September 9, 2020
• Last Updated: September 11, 2020

Record last verified: 2020-09

Data Sharing

• IPD Sharing: Will not share

Locations

IL (1)