Ridge Augmentation: Particulate v/s Block Graft
Primary Purpose
Alveolar Bone Loss
Status
Completed
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Block allograft
Particulate allograft + autogenous bone chips
Sponsored by
About this trial
This is an interventional treatment trial for Alveolar Bone Loss
Eligibility Criteria
Inclusion Criteria:
- At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
- Healthy person that is at least 18 years old.
- Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.
Exclusion Criteria:
- Patients with debilitating systemic diseases, diseases that significantly affect the periodontium, or psychological problems that would interfere with treatment.
- Previous head and neck radiation or chemotherapy within the previous 12 months.
- Patients with known allergy to any of the materials that will be used in the study.
- Smokers.
- Patients on oral bisphosphonates > 3 years or any IV bisphosphonates.
- Patients who are pregnant.
Sites / Locations
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Active Comparator
Arm Label
Particulate allograft + autogenous bone.
Block allograft
Arm Description
In the test arm of the study the treatment will include a mix of MinerOss CorticoCancellous Particulate allograft + autogenous bone chips.
The positive control treatment will include a block allograft plus Mineross corticocancellous particulate allograft.
Outcomes
Primary Outcome Measures
Horizontal ridge width changes
Site width (horizontal) changes by comparing the pre- to the 4 month post- augmentation dimensions of hard tissues.
Secondary Outcome Measures
Vertical ridge height changes
Site height (vertical) changes by comparing the pre- to the 4 month post-augmentation dimensions of hard tissues.
Histologic composition of the graft
Histologic composition at 4 month post graft. (Histologic percent vital bone, nonvital bone and trabecular space.)
Full Information
NCT ID
NCT02487784
First Posted
June 19, 2015
Last Updated
December 31, 2017
Sponsor
University of Louisville
1. Study Identification
Unique Protocol Identification Number
NCT02487784
Brief Title
Ridge Augmentation: Particulate v/s Block Graft
Official Title
Ridge Augmentation Comparing the Clinical and Histologic Healing of a Cancellous Block Allograft Versus Corticocancellous Particulate Allograft Mixed With Autogenous Bone Chips
Study Type
Interventional
2. Study Status
Record Verification Date
December 2017
Overall Recruitment Status
Completed
Study Start Date
August 2015 (undefined)
Primary Completion Date
June 2016 (Actual)
Study Completion Date
June 2016 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
University of Louisville
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
The primary aims of this study are to compare the clinical and histologic results of bone regeneration with a cancellous block allograft versus MinerOss Cortico cancellous particulate allograft mixed with autogenous bone chips after 4 months of healing. Titanium reinforced hd-PTFE (Cytoplast) membrane GBR will be used to cover the bone grafts.
Specific Aim 1: To compare the baseline to 4 month change in clinical ridge width and height.
Specific Aim 2: To compare the histologic percent of vital and nonvital bone and trabecular space at 4 months.
The primary outcome variable is the change in horizontal ridge width. The secondary outcomes are the change in ridge height and the percent histologic composition of the augmented site.
Detailed Description
30 patients will be treated using the principles of guided bone regeneration and ridge augmentation. 15 test patients will receive a corticocancellous particulate allograft mixed with autogenous bone chips. The positive control group of 15 patients will receive a cancellous block allograft. Both the groups will receive a hd-PTFE (Cytoplast) barrier membrane. An allograft can be defined as bone that can be obtained from a different individual of the same species (human donor bone) whereas a autograft can be defined as bone that can be obtained from the same individual. Following flap reflection, vertical measurements will be done using a acrylic occlusal stent and horizontal measurements will be done using a specially designed caliper. Approximately 4 months post surgery, a trephine core will be taken from the grafted site immediately prior to the implant placement and submitted for histologic processing. The last step in the study will be to obtain a trephine core (2.7 X 6mm). After the core is harvested a dental implant will be placed. Implant placement should be considered a post study treatment procedure. There is no intent to investigate implant placement outcome. Step serial sections will be taken from each longitudinally sectioned core. The sections will be stained with hematoxylin and eosin. Ten slides per patient will be prepared with at least 4 sections per slide. For each patient 6 of 10 slides will be assessed. The mean percentages of vital and non vital bone and trabecular space will be determined for each patient by using an American Optical Microscope at 150X with a 10 X10 ocular grid. Histologic preparation will result in destruction of the trephine cores. Means and standard deviations will be calculated for all parameters. A paired t-test will be used to evaluate the statistical significance of the differences between initial and final data. An unpaired t-test will be used to evaluate statistical differences between the test and control groups.
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
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
15 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Particulate allograft + autogenous bone.
Arm Type
Experimental
Arm Description
In the test arm of the study the treatment will include a mix of MinerOss CorticoCancellous Particulate allograft + autogenous bone chips.
Arm Title
Block allograft
Arm Type
Active Comparator
Arm Description
The positive control treatment will include a block allograft plus Mineross corticocancellous particulate allograft.
Intervention Type
Procedure
Intervention Name(s)
Block allograft
Other Intervention Name(s)
Cancellous block allograft
Intervention Description
A cancellous block allograft plus corticocancellous particulate allograft will be used as the positive control treatment.
Intervention Type
Procedure
Intervention Name(s)
Particulate allograft + autogenous bone chips
Other Intervention Name(s)
Particulate + ABC
Intervention Description
The test arm of this study will include a mix of particulate bone allograft and autogenous bone chips.
Primary Outcome Measure Information:
Title
Horizontal ridge width changes
Description
Site width (horizontal) changes by comparing the pre- to the 4 month post- augmentation dimensions of hard tissues.
Time Frame
4 months
Secondary Outcome Measure Information:
Title
Vertical ridge height changes
Description
Site height (vertical) changes by comparing the pre- to the 4 month post-augmentation dimensions of hard tissues.
Time Frame
4 months
Title
Histologic composition of the graft
Description
Histologic composition at 4 month post graft. (Histologic percent vital bone, nonvital bone and trabecular space.)
Time Frame
4 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
At least a one tooth area with a ridge defect, treatment planned to receive a dental implant. The site must be bordered by at least one tooth.
Healthy person that is at least 18 years old.
Patient understands and signs an informed consent approved by the University of Louisville Human Studies Committee.
Exclusion Criteria:
Patients with debilitating systemic diseases, diseases that significantly affect the periodontium, or psychological problems that would interfere with treatment.
Previous head and neck radiation or chemotherapy within the previous 12 months.
Patients with known allergy to any of the materials that will be used in the study.
Smokers.
Patients on oral bisphosphonates > 3 years or any IV bisphosphonates.
Patients who are pregnant.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Henry Greenwell, DMD, MSD
Organizational Affiliation
Director of Graduate Periodontics, School of Dentistry, University of Louisville.
Official's Role
Principal Investigator
12. IPD Sharing Statement
Learn more about this trial
Ridge Augmentation: Particulate v/s Block Graft
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