Implant Stability in Autogenous Mineralized and Demineralized Dentin Grafts

NCT ID: NCT05219305

Last Updated: 2024-08-16

Basic Information

• Recruitment Status: ACTIVE_NOT_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 36 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-04-01
• Study Completion Date: 2024-12-31

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.

Detailed Description

This study will be a randomized controlled trial that will assess the changes in implant stability, survival, failure rate, probing pocket depth, and interproximal crestal bone level changes recorded by ISQ (Implant Stability Quotient), probing pocket depths, x-ray, and direct clinical measurements which are routinely taken as a standard of care for the dental procedures of implant placement and evaluation. A non-invasive standardizing stent with a caliper will be used for direct measurements and for bitewing radiographs for the purpose of evaluating changes in bone level. Those measurements will be taken immediately at the time of implant placement, and 4-6 months after implant placement. Calibrated examiners will evaluate implant integration. This research will be carried out by a blinded examiner who will not know the grafted material type to prevent bias.

Interventions and follow-up appointments will be conducted at the University of Oklahoma (OU), Graduate Periodontics clinic. Approximately 5 visits are anticipated for each patient. Additional appointments may be needed depending on surgical complications that need attention or intervention. Following the completion of the study, the participants will be placed on appropriate recall schedules either at the Graduate Periodontics clinic or referred to their dentist of choice. The subject's information will not be used or distributed for future research studies even if identifiers are removed.

Patients from the previous study "Alveolar Ridge Preservation with evenly distributed experimental groups of FDBA, Mineralized, and Partially Demineralized Dentin Grafts". A total of 60 patients treated with Alveolar Ridge Preservation will be eligible for implant placement.

Protocol of the experiment is as follows:

1. Surgical intervention for implant placement (for all the groups).

2. 2-week follow-up after implant placement.

3. 6-week follow-up after implant placement.

4. 4-6 month follow-up after implant placement.

5. Restoration of the implant by the restorative dentist.

6. Data analysis

During the implant placement phase, at 4 to 6 months postoperative from the grafted sites, bone core sample will be collected using a trephine bur. Collection of sample with a trephine bur will come from area of bone being prepared for the dental implant and will be of a size that would have been removed during dental implant preparation anyway. This will occur during the same appointment as dental implant placement. The collected specimens will be labeled (name of the patient, date, and chart number) and sent to the OU Department of Oral Pathology where it will be analyzed for newly formed bone and the amount of residual bone graft material. This research will be carried out by a blinded examiner who will not know the grafted material type to prevent bias.

No population will be excluded based on race or gender. Patients under 18 years old will be excluded due to the ongoing growth potential of the alveolar bone at a younger age.

This study will be conducted at the University of Oklahoma, College of Dentistry, Department of Graduate Periodontics. Participants will be selected from patients of the College of Dentistry. Qualifying subjects will be scheduled for a screening examination appointment.

Conditions

Edentulous Alveolar Ridge

Study Design

• Allocation Method: NON_RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Freeze-Dried Bone Allograft

edentulous site grafted with FDBA in previous study.

Group Type: EXPERIMENTAL

Dental Implant Placement

Intervention Type: DEVICE

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

Partially-demineralized tooth graft

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

Group Type: EXPERIMENTAL

Dental Implant Placement

Intervention Type: DEVICE

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

mineralized tooth graft

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

Group Type: EXPERIMENTAL

Dental Implant Placement

Intervention Type: DEVICE

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

Interventions

Dental Implant Placement

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

Intervention Type: DEVICE

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Zimmer Biomet

INDUSTRY

Sponsor Role: collaborator

University of Oklahoma

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Robin Henderson, DDS, MS

Role: PRINCIPAL_INVESTIGATOR

University of Oklahoma

Locations

University of Oklahoma College of Dentistry Graduate Periodontics

Oklahoma City, Oklahoma, United States

Countries

United States

References

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.

Reference Type: RESULT

PMID: 22697628 (View on PubMed)

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

Reference Type: 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.

Reference Type: RESULT

PMID: 9893518 (View on PubMed)

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.

Reference Type: RESULT

PMID: 11063392 (View on PubMed)

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.

Reference Type: RESULT

PMID: 19031159 (View on PubMed)

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.

Reference Type: RESULT

PMID: 18938268 (View on PubMed)

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.

Reference Type: RESULT

PMID: 20060336 (View on PubMed)

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.

Reference Type: RESULT

PMID: 22939321 (View on PubMed)

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.

Reference Type: RESULT

PMID: 26795024 (View on PubMed)

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

Reference Type: 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.

Reference Type: RESULT

PMID: 30578550 (View on PubMed)

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.

Reference Type: RESULT

PMID: 31529723 (View on PubMed)

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.

Reference Type: 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.

Reference Type: RESULT

PMID: 33370452 (View on PubMed)

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.

Reference Type: RESULT

PMID: 30904559 (View on PubMed)

Other Identifiers

14063

Identifier Type: -

Identifier Source: org_study_id