Mineralized and Partial Demineralized Dentin Graft Compared to FDBA

Alveolar Bone Loss Clinical Trial

Official title:

Autogenous Mineralized and Partial Demineralized Dentin Graft Compared to Freeze Dried Bone Allograft: A Randomized Control Trial

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05311735
• Other study ID #: 13712
• Status: Recruiting
• Phase: N/A
• Start date: October 29, 2021
• Est. completion date: June 2024

Study information

• Verified date: May 2024
• Source: University of Oklahoma
• Contact: Robin D Henderson, DMD MS
• Phone: 405-271-8001
• Email: robin-henderson[@]ouhsc.edu
• 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 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.

Description:

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.

A. Specific Aims

Specific Aim 1:

Is there a clinical-radiographical difference in terms of bone volume and density between mineralized dentin grafts, partial demineralized tooth grafts, and FDBA?

Null Hypothesis (Ho): Experimental groups (Mineralized, and partial demineralized dentin grafts) do not have positive changes in terms of bone volume and density when compared to FDBA

Alternative Hypothesis (H1): Experimental groups (Mineralized, and partial demineralized dentin grafts) show better results in terms of bone volume and density when compared to FDBA.

Secondary Aim:

Evaluate if there is any difference in terms of efficacy among partial-demineralized dentin graft, mineralized dentin graft and FDBA.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 45
• Est. completion date: June 2024
• Est. primary completion date: June 2024
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• 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.

Exclusion Criteria:

• 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

Related Conditions & MeSH terms

• Alveolar Bone Loss

Intervention

Procedure:
• Freeze-Dried Bone Allograft control
Bone grafting to prevent alveolar ridge collapse after tooth removal
• Mineralized Dentin Graft
Mineralized tooth graft used as a bone graft substitute to prevent alveolar ridge collapse after tooth removal
• Partial-Demineralized Dentin Graft
Partially mineralized tooth graft used as a bone graft substitute to prevent alveolar ridge collapse after tooth removal

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	Delta Dental Foundation

Country where clinical trial is conducted

United States, 

References & Publications (9)

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

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.1600-0501.2012.02522.x. Epub 2012 Jun 15. — 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):e39-45. doi: 10.1016/j.oooo.2012.04.018. Epub 2012 Aug 30. — 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. eCollection 2016. — View Citation

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

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	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	Surgical efficiency utilizing dentin tooth graft and FDBA.	Is there any difference in terms of surgical efficiency among partial-demineralized tooth graft, mineralized tooth graft and FDBA, as determined by length of time of surgical procedure?	6 months post guided bone regeneration procedure
Secondary	Surgical cost saving measurement utilizing dentin tooth graft and FDBA.	Is there any difference in terms of surgical cost savings among partial-demineralized tooth graft, mineralized tooth graft and FDBA, as determined by length of time of surgical procedure, as measured by the total overhead expended per procedure type?	6 months post guided bone regeneration procedure