Mineralized and Partial Demineralized Dentin Graft Compared to FDBA

NCT05311735 | Completed FDA Device

• 1 other identifier: 13712
• Study Type: interventional
• Target: 45
• Locations: 1 country
• Sites: 1

Brief Summary

The bone grafting materials currently used in dentistry are autografts, allografts, xenografts, and alloplastic grafts. Among these different types of bone graft materials, autografts are considered to have the most predictable results due to its properties of osteogenesis, osteoinduction and osteoconduction. However, bone autografts are rarely used due to the high morbidity associated with harvesting the bone graft from the patient with a second surgical site. Because of the increased risk to the patient with autogenous bone grafts, the current standard of care is an allograft, which is a bone graft harvested from cadaver sources such as Freeze-Dried Bone Allograft (FDBA). While allografts can only possess the qualities of osteoinduction and osteoconduction, they also have dramatically less morbidity due to the lack of a second surgical site. Studies have shown that autogenous dentin grafts promote all three ideal mechanisms for bone regeneration. There are two methods to generate autogenous dentin grafts. One is to collect the extracted tooth and to send it to a tooth bank for the preparation process. The second is to process the extracted tooth in a clinical setting chairside, for a graft. A dentin graft can undergo different treatments such as demineralization, mineralization, and partial-demineralization. Although the autogenous dentin graft has shown positive results for bone regeneration, the comparison between partial-demineralized, mineralized autogenous dentin grafts, and freeze-dried bone grafts in the clinical setting for immediate grafting has not been studied in humans. Thus, there is a need to study the benefits of autogenous dentin partial-demineralized and mineralized grafts versus freeze-dried bone allografts regarding clinical, radiographically (bone volume and density), and efficacy results. This research addresses these areas of need.

Conditions

Alveolar Bone Loss

Outcome Measures

Primary Outcomes (2)

• Clinical-radiographical differences in terms of bone volume between dentin tooth grafts and FDBA.

  Is there a clinical-radiographical difference in terms of bone volume between mineralized dentin grafts, partial demineralized tooth grafts and FDBA, as measured in millimeters, with calibrated devices?

  6 months post guided bone regeneration procedure

• Clinical-radiographical differences in terms of bone density between dentin tooth grafts and FDBA.

  Is there a clinical-radiographical difference in terms of bone density between mineralized dentin grafts, partial demineralized tooth grafts and FDBA, as measured with Hounsfield Units?

  6 months post guided bone regeneration procedure

Secondary Outcomes (2)

• Surgical efficiency utilizing dentin tooth graft and FDBA.

  6 months post guided bone regeneration procedure

• Surgical cost saving measurement utilizing dentin tooth graft and FDBA.

  6 months post guided bone regeneration procedure

Study Arms (3)

Freeze-Dried Bone Allograft Control

OTHER

-Control group (FDBA): extracted teeth will be discarded and sites will be grafted with FDBA.

Procedure: Freeze-Dried Bone Allograft control

Mineralized Dentin Graft

EXPERIMENTAL

-Test group I (mineralized tooth graft): extracted teeth will undergo the mineralization process according to the manufacture's guidelines. Procedure will be done in a specialized equipment for tooth graft preparation (Smart Dentin Grinder® (SDG) (KometaBio), and then sites will be grafted. Remaining graft will be stored appropriately for future grafting in the same patient (according to the guidelines)

Procedure: Mineralized Dentin Graft

Partial-Demineralized Dentin Graft

EXPERIMENTAL

-Test group II (partial-demineralized tooth graft): extracted teeth will be undergone to partial-demineralized process, according to the manufacture's guidelines. Procedures will be done in a specialized equipment for tooth graft preparation (Smart Dentin Grinder® (SDG) (KometaBio), and then sites will be grafted. Remaining graft will be stored appropriately for future grafting in the same patient (according to the guidelines).

Procedure: Partial-Demineralized Dentin Graft

Interventions

Freeze-Dried Bone Allograft control PROCEDURE

Bone grafting to prevent alveolar ridge collapse after tooth removal

Freeze-Dried Bone Allograft Control

Mineralized Dentin Graft PROCEDURE

Mineralized tooth graft used as a bone graft substitute to prevent alveolar ridge collapse after tooth removal

Mineralized Dentin Graft

Partial-Demineralized Dentin Graft PROCEDURE

Partially mineralized tooth graft used as a bone graft substitute to prevent alveolar ridge collapse after tooth removal

Partial-Demineralized Dentin Graft

Eligibility Criteria

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

You may qualify if:

• Adult patients ≥18 years old
• Able to understand and sign a written informed consent form and willing to fulfil all study requirements.
• Alveolar sockets with intact four-wall architecture.
• Patients with at least a tooth that need to be extracted.

You may not qualify if:

• Uncontrolled systemic disease
• Currently smoking \>10 cigarettes per day
• History of head and/or neck radiotherapy in the past five years
• Bisphosphonates current use or history of IV bisphosphonate
• Pregnant, expecting to become pregnant, or lactating women.
• Presence of active periodontal disease.
• Teeth that underwent root canal fillings
• Teeth with acute infection at the site of extraction.
• Teeth with periapical infection

Sponsors & Collaborators

• University of Oklahoma: lead
• Delta Dental Foundation: collaborator

Study Sites (1)

University of Oklahoma College of Dentistry Graduate Periodontics

Oklahoma City, Oklahoma, 73117, United States

Location

Related Publications (9)

• Jung RE, Fenner N, Hammerle CH, Zitzmann NU. Long-term outcome of implants placed with guided bone regeneration (GBR) using resorbable and non-resorbable membranes after 12-14 years. Clin Oral Implants Res. 2013 Oct;24(10):1065-73. doi: 10.1111/j.1600-0501.2012.02522.x. Epub 2012 Jun 15.

  PMID: 22697628 BACKGROUND

• Ike M, Urist MR. Recycled dentin root matrix for a carrier of recombinant human bone morphogenetic protein. J Oral Implantol. 1998;24(3):124-32. doi: 10.1563/1548-1336(1998)0242.3.CO;2.

  PMID: 9893518 BACKGROUND

• Saygin NE, Tokiyasu Y, Giannobile WV, Somerman MJ. Growth factors regulate expression of mineral associated genes in cementoblasts. J Periodontol. 2000 Oct;71(10):1591-600. doi: 10.1902/jop.2000.71.10.1591.

  PMID: 11063392 BACKGROUND

• Emecen P, Akman AC, Hakki SS, Hakki EE, Demiralp B, Tozum TF, Nohutcu RM. ABM/P-15 modulates proliferation and mRNA synthesis of growth factors of periodontal ligament cells. Acta Odontol Scand. 2009;67(2):65-73. doi: 10.1080/00016350802555525.

  PMID: 19031159 BACKGROUND

• Kim YK, Kim SG, Byeon JH, Lee HJ, Um IU, Lim SC, Kim SY. Development of a novel bone grafting material using autogenous teeth. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2010 Apr;109(4):496-503. doi: 10.1016/j.tripleo.2009.10.017. Epub 2010 Jan 8.

  PMID: 20060336 BACKGROUND

• Kim YK, Kim SG, Yun PY, Yeo IS, Jin SC, Oh JS, Kim HJ, Yu SK, Lee SY, Kim JS, Um IW, Jeong MA, Kim GW. Autogenous teeth used for bone grafting: a comparison with traditional grafting materials. Oral Surg Oral Med Oral Pathol Oral Radiol. 2014 Jan;117(1):e39-45. doi: 10.1016/j.oooo.2012.04.018. Epub 2012 Aug 30.

  PMID: 22939321 BACKGROUND

• Koga T, Minamizato T, Kawai Y, Miura K, I T, Nakatani Y, Sumita Y, Asahina I. Bone Regeneration Using Dentin Matrix Depends on the Degree of Demineralization and Particle Size. PLoS One. 2016 Jan 21;11(1):e0147235. doi: 10.1371/journal.pone.0147235. eCollection 2016.

  PMID: 26795024 BACKGROUND

• Binderman, Itzhak, Gideon Hallel, Casap Nardy, Avinoam Yaffe, and Lari Sapoznikov.

  BACKGROUND

• Phillips DJ, Swenson DT, Johnson TM. Buccal bone thickness adjacent to virtual dental implants following guided bone regeneration. J Periodontol. 2019 Jun;90(6):595-607. doi: 10.1002/JPER.18-0304. Epub 2019 Jan 10.

  PMID: 30578550 BACKGROUND

MeSH Terms

Conditions

Alveolar Bone Loss

Condition Hierarchy (Ancestors)

Bone Resorption; Bone Diseases; Musculoskeletal Diseases; Periodontal Atrophy; Periodontal Diseases; Mouth Diseases; Stomatognathic Diseases

Study Officials

• Robin Henderson, DMD MS

  University of Oklahoma College of Dentistry

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: * Test group I (mineralized tooth graft): extracted teeth will undergo the mineralization process according to the manufacture's guidelines. Procedure will be done in a specialized equipment for tooth graft preparation (Smart Dentin Grinder® (SDG) (KometaBio), and then sites will be grafted. Remaining graft will be stored appropriately for future grafting in the same patient (according to the guidelines) * Test group II (partial-demineralized tooth graft): extracted teeth will be undergone to partial-demineralized process, according to the manufacture's guidelines. Procedures will be done in a specialized equipment for tooth graft preparation (Smart Dentin Grinder® (SDG) (KometaBio), and then sites will be grafted. Remaining graft will be stored appropriately for future grafting in the same patient (according to the guidelines). * Control group (FDBA): extracted teeth will be discarded and sites will be grafted with FDBA.

Study Record Dates

• First Submitted: February 21, 2022
• First Posted: April 5, 2022
• Study Start: October 29, 2021
• Primary Completion: June 17, 2022
• Study Completion: June 19, 2024
• Last Updated: July 10, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: The estimated time frame for sharing data would be approximately until May 2025
• Access Criteria: Institutional Review Board officials, Master Thesis Chair and Committee members, and statisticians, will be able to review data. Also, Dr. John Corbett, will be performing a followup study and possibly extending the time frame for Dr. Perozo's study measurement. It is also anticipated, but not actual, that future studies be performed for longitudinal analysis.

Locations

US (1)