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Mineralized and Partial Demineralized Dentin Graft Compared to FDBA

Primary Purpose

Alveolar Bone Loss

Status
Recruiting
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Freeze-Dried Bone Allograft control
Mineralized Dentin Graft
Partial-Demineralized Dentin Graft
Sponsored by
University of Oklahoma
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Alveolar Bone Loss

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • University of Oklahoma College of Dentistry Graduate PeriodonticsRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Other

Experimental

Experimental

Arm Label

Freeze-Dried Bone Allograft Control

Mineralized Dentin Graft

Partial-Demineralized Dentin Graft

Arm Description

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

-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).

Outcomes

Primary Outcome Measures

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?
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?

Secondary Outcome Measures

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?
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?

Full Information

First Posted
February 21, 2022
Last Updated
May 8, 2023
Sponsor
University of Oklahoma
Collaborators
Delta Dental Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT05311735
Brief Title
Mineralized and Partial Demineralized Dentin Graft Compared to FDBA
Official Title
Autogenous Mineralized and Partial Demineralized Dentin Graft Compared to Freeze Dried Bone Allograft: A Randomized Control Trial
Study Type
Interventional

2. Study Status

Record Verification Date
May 2023
Overall Recruitment Status
Recruiting
Study Start Date
October 29, 2021 (Actual)
Primary Completion Date
June 2024 (Anticipated)
Study Completion Date
June 2024 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Oklahoma
Collaborators
Delta Dental Foundation

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
Yes
Product Manufactured in and Exported from the U.S.
Yes
Data Monitoring Committee
No

5. Study Description

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.
Detailed 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Alveolar Bone Loss

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Model Description
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.
Masking
None (Open Label)
Allocation
Randomized
Enrollment
45 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
Freeze-Dried Bone Allograft Control
Arm Type
Other
Arm Description
-Control group (FDBA): extracted teeth will be discarded and sites will be grafted with FDBA.
Arm Title
Mineralized Dentin Graft
Arm Type
Experimental
Arm Description
-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)
Arm Title
Partial-Demineralized Dentin Graft
Arm Type
Experimental
Arm Description
-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).
Intervention Type
Procedure
Intervention Name(s)
Freeze-Dried Bone Allograft control
Intervention Description
Bone grafting to prevent alveolar ridge collapse after tooth removal
Intervention Type
Procedure
Intervention Name(s)
Mineralized Dentin Graft
Intervention Description
Mineralized tooth graft used as a bone graft substitute to prevent alveolar ridge collapse after tooth removal
Intervention Type
Procedure
Intervention Name(s)
Partial-Demineralized Dentin Graft
Intervention Description
Partially mineralized tooth graft used as a bone graft substitute to prevent alveolar ridge collapse after tooth removal
Primary Outcome Measure Information:
Title
Clinical-radiographical differences in terms of bone volume between dentin tooth grafts and FDBA.
Description
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?
Time Frame
6 months post guided bone regeneration procedure
Title
Clinical-radiographical differences in terms of bone density between dentin tooth grafts and FDBA.
Description
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?
Time Frame
6 months post guided bone regeneration procedure
Secondary Outcome Measure Information:
Title
Surgical efficiency utilizing dentin tooth graft and FDBA.
Description
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?
Time Frame
6 months post guided bone regeneration procedure
Title
Surgical cost saving measurement utilizing dentin tooth graft and FDBA.
Description
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?
Time Frame
6 months post guided bone regeneration procedure

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Robin D Henderson, DMD MS
Phone
405-271-8001
Ext
34173
Email
robin-henderson@ouhsc.edu
First Name & Middle Initial & Last Name or Official Title & Degree
Sandra Perozo, BDS
Phone
832-991-2555
Email
sandra-perozovasquez@ouhsc.edu
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robin Henderson, DMD MS
Organizational Affiliation
University of Oklahoma College of Dentistry
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Oklahoma College of Dentistry Graduate Periodontics
City
Oklahoma City
State/Province
Oklahoma
ZIP/Postal Code
73117
Country
United States
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Sandra Perozo, BDS
Phone
405-271-8001
Email
sandra-perozovazquez@ouhsc.edu
First Name & Middle Initial & Last Name & Degree
Robin Henderson, DMD MS
Phone
405-271-8001
Ext
34173
Email
robin-henderson@ouhsc.edu

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
It is estimated that individual patient date will be shared to a very limited number of individuals to help with facilitating the statistical analysis of the study, as well as writing up the Master Thesis and future publications. Also, upon request, it is required to share study related information to our internal Institutional Review Board.
IPD Sharing Time Frame
The estimated time frame for sharing data would be approximately until May 2025
IPD Sharing 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.
Citations:
PubMed Identifier
22697628
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.
Results Reference
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PubMed Identifier
9893518
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.
Results Reference
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PubMed Identifier
11063392
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.
Results Reference
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PubMed Identifier
19031159
Citation
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.
Results Reference
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PubMed Identifier
20060336
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.
Results Reference
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PubMed Identifier
22939321
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.
Results Reference
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PubMed Identifier
26795024
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.
Results Reference
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Citation
Binderman, Itzhak, Gideon Hallel, Casap Nardy, Avinoam Yaffe, and Lari Sapoznikov.
Results Reference
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PubMed Identifier
30578550
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.
Results Reference
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Mineralized and Partial Demineralized Dentin Graft Compared to FDBA

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