Implant Stability in Autogenous Mineralized and Demineralized Dentin Grafts

NCT05219305 | Active Not Recruiting FDA Device

• 1 other identifier: 14063
• Study Type: interventional
• Target: 36
• 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 their 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. Our null hypothesis states that: Experimental groups (mineralized, and partially demineralized dentin grafts) do not show positive changes in implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes when compared to FDBA Our alternative hypothesis states that: Experimental groups (mineralized, and partially demineralized dentin grafts) show similar or better results in terms of implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes when compared to FDBA.

Conditions

Edentulous Alveolar Ridge

Keywords

dental implant,; autogenous dentin graft; autograft; allograft; bone graft

Outcome Measures

Primary Outcomes (4)

• Implant Stability as Measured with ISQ values of implant

  Measurement of ISQ (Implant Stability Quotient) values of implant at follow-up appointments

  6 months

• Implant Failure Rate

  Necessity of implant of implant removal from oral cavity

  6 months

• Probing pocket depth

  measuring the depth of the periodontal pocket alongside the dental implant

  6 months

• Interproximal crestal bone level

  radiographically assess bone level changes adjacent to dental implant

  6 months

Study Arms (3)

Freeze-Dried Bone Allograft

EXPERIMENTAL

edentulous site grafted with FDBA in previous study.

Device: Dental Implant Placement

Partially-demineralized tooth graft

EXPERIMENTAL

edentulous site grafted with partially-demineralized tooth graft in the previous study.

Device: Dental Implant Placement

mineralized tooth graft

EXPERIMENTAL

edentulous site grafted with mineralized tooth graft in the previous study.

Device: Dental Implant Placement

Interventions

Dental Implant Placement DEVICE

Placement in an edentulous site that was previously bone grafted in the prior study.

Freeze-Dried Bone Allograft; Partially-demineralized tooth graft; mineralized tooth graft

Eligibility Criteria

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

You may qualify if:

• Adult patients ≥18 years old. Current literature suggests that patients up to age 80 can safely receive dental implants. Patients older than 80 can get implant therapy with a rate of implant failure increase of 2.26%, but not statistically significant (Bertl et al. 2019)
• Well-controlled systemic disease.
• Able to understand and sign a written informed consent form and willing to fulfill all study requirements.

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.
• Current use of bisphosphonates or history of IV bisphosphonate therapy.
• Pregnant, expecting to become pregnant, or lactating women.
• Presence of active periodontal disease.

Sponsors & Collaborators

• University of Oklahoma: lead
• Zimmer Biomet: collaborator

Study Sites (1)

University of Oklahoma College of Dentistry Graduate Periodontics

Oklahoma City, Oklahoma, 73117, United States

Location

Related Publications (15)

• 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 RESULT

• Murata, M. "Autogenous demineralized dentin matrix for maxillary sinus augmentation in human. The first clinical report." Journal of Dental Reseach., 82, B243.

  RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

• Seo BM, Sonoyama W, Yamaza T, Coppe C, Kikuiri T, Akiyama K, Lee JS, Shi S. SHED repair critical-size calvarial defects in mice. Oral Dis. 2008 Jul;14(5):428-34. doi: 10.1111/j.1601-0825.2007.01396.x.

  PMID: 18938268 RESULT

• 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 RESULT

• 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 RESULT

• 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 RESULT

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

  RESULT

• 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 RESULT

• Bertl K, Ebner M, Knibbe M, Pandis N, Kuchler U, Ulm C, Stavropoulos A. How old is old for implant therapy in terms of early implant losses? J Clin Periodontol. 2019 Dec;46(12):1282-1293. doi: 10.1111/jcpe.13199. Epub 2019 Nov 8.

  PMID: 31529723 RESULT

• Binderman, I., Hallel, G., Nardy, C., Yaffe, A., & Sapoznikov, L. (2014). A novel procedure to process extracted teeth for immediate grafting of autogenous dentin. J Interdiscipl Med Dent Sci, 2(154), 2.

  RESULT

• Korsch M. Tooth shell technique: A proof of concept with the use of autogenous dentin block grafts. Aust Dent J. 2021 Jun;66(2):159-168. doi: 10.1111/adj.12814. Epub 2021 Jan 25.

  PMID: 33370452 RESULT

• Howe MS, Keys W, Richards D. Long-term (10-year) dental implant survival: A systematic review and sensitivity meta-analysis. J Dent. 2019 May;84:9-21. doi: 10.1016/j.jdent.2019.03.008. Epub 2019 Mar 20.

  PMID: 30904559 RESULT

Study Officials

• Robin Henderson, DDS, MS

  University of Oklahoma

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: Investigator completed randomization program and delivered grafting material to patient/dentist at time of grafting. Patients and providers still blinded as to which group they were assigned.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: All participants originate from previous study ""Alveolar Ridge Preservation with evenly distributed experimental groups of FDBA, Mineralized, and Partially Demineralized Dentin Grafts". They have already been assigned and treated with different types of bone grafts. They were assigned groups via a computer randomization program.

Study Record Dates

• First Submitted: January 18, 2022
• First Posted: February 2, 2022
• Study Start: April 1, 2022
• Primary Completion: August 10, 2023
• Study Completion: December 1, 2024
• Last Updated: August 16, 2024

Record last verified: 2024-08

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)