Implant Stability in Autogenous Mineralized and Demineralized Dentin Grafts

Edentulous Alveolar Ridge Clinical Trial

Official title:

Autogenous Mineralized Dentin Graft Compared to Partial Demineralized Tooth Graft and to Freeze-Dried Bone Allograft in Dental Implant Placement

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT05219305
• Other study ID #: 14063
• Status: Active, not recruiting
• Phase: N/A
• Start date: April 1, 2022
• Est. completion date: June 2024

Study information

• Verified date: November 2023
• Source: University of Oklahoma
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 36
• Est. completion date: June 2024
• Est. primary completion date: August 10, 2023
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Edentulous Alveolar Ridge
• Mouth, Edentulous

Intervention

Device:
• Dental Implant Placement
Placement in an edentulous site that was previously bone grafted in the prior study.

Locations

Country	Name	City	State
United States	University of Oklahoma College of Dentistry Graduate Periodontics	Oklahoma City	Oklahoma

Sponsors (2)

Lead Sponsor	Collaborator
University of Oklahoma	Zimmer Biomet

Country where clinical trial is conducted

United States, 

References & Publications (15)

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. — View Citation

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.

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

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. — View Citation

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. — View Citation

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. — View Citation

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.1600-050 — View Citation

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. — View Citation

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):e — View Citation

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. eColl — View Citation

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. — View Citation

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

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. — View Citation

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. — View Citation

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. Erratum In: Oral Dis. 2009 May;15(4):302. — View Citation

* Note: There are 15 references in all — Click here to view all references

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Implant Stability as Measured with ISQ values of implant	Measurement of ISQ (Implant Stability Quotient) values of implant at follow-up appointments	6 months
Primary	Implant Failure Rate	Necessity of implant of implant removal from oral cavity	6 months
Primary	Probing pocket depth	measuring the depth of the periodontal pocket alongside the dental implant	6 months
Primary	Interproximal crestal bone level	radiographically assess bone level changes adjacent to dental implant	6 months