Back to resultsComparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials
Primary Purpose
Tooth Fractures, Tooth Injuries, Tooth Diseases
Status
Terminated
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Allograft, Membrane
Alloplast, Membrane
Xenograft, Membrane
Membrane
Sponsored by
About this trial
This is an interventional treatment trial for Tooth Fractures
Eligibility Criteria
Inclusion Criteria:
- Provision of informed consent
- ≥ 18 years and ≤ 75 years
- Good physical health (ASAI/II)
- Extraction of maxillary premolar, canine or incisor, or mandibular premolar and canine required
- Teeth adjacent (mesial and distal) to study site must consist of two stable natural teeth with minimal restorations, without signs of periodontal bone loss (> 3 mm) and/or significant soft tissue deficiencies
Exclusion Criteria:
- Buccal plate dehiscence and/or fenestration >3mm at study site following extraction
- Untreated rampant caries and uncontrolled periodontal disease
- Inadequate oral hygiene (estimated plaque score >20%)
- Smokers using more than 10 cigarettes or equivalent per day
- Smokeless tobacco use or e-cigarette use
Compromised physical health and/or uncontrolled or severe systemic diseases including:
ASA III/IV Metabolic bone disease History of malignancy History or radiotherapy or chemotherapy for malignancy in the past 5 years History of autoimmune disease Long-term steroidal or antibiotic therapy Uncontrolled diabetes Known alcohol or drug abuse
- Systemic or local disease or condition that would compromise post-operative healing
- Use of any substance or medication that will influence bone metabolism
- Known pregnancy
- Unable or unwilling to return for follow-up visits for a period of 6 months
- Unlikely to be able to comply with study procedures according to Investigators judgement
- Involvement in the planning and conduct of the study
- Previous enrollment or randomization of treatment in the present study
Sites / Locations
- University of North Carolina School of Dentistry
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm 4
Arm Type
Active Comparator
Active Comparator
Active Comparator
Active Comparator
Arm Label
Group A- Allograft, Membrane
Group B- Alloplast, Membrane
Group C- Xenograft, Membrane
Group D- Membrane
Arm Description
Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane
Symbios OsteoShield Collagen Resorbable Membrane
Outcomes
Primary Outcome Measures
Total Mean Change in Bone Volume
The change in bone volume at 3 months following extraction will be calculated using data from DICOM images acquired by Cone Beam Computed Tomography (CBCT) using 3D software
Secondary Outcome Measures
Mean Osseous Dimensional Changes-Horizontal
The amount of linear (mm) horizontal bone change at 3 months following tooth extraction at a position located 2mm and 4mm vertically away from the height of the buccal plate. Data will be calculated using data from DICOM images acquired by CBCT using 3D software.
Mean Osseous Dimensional Changes-Vertical
The amount of linear (mm) vertical bone change at 3 months following tooth extraction at a position located mid-buccal, mid-palatal, mesial and distal of the extraction site. Data will be calculated using data from DICOM images acquired by CBCT using 3D software.
Total Mean Change in Soft Tissue Volume
The change in soft tissue volume at 3 months following tooth extraction will be assessed through the use of 3D scans of patient dental models at two time points following extraction and ridge preservation at 3 months.
Mean Soft Tissue Dimensional Changes-Horizontal
The amount of linear (mm) horizontal soft tissue change at 3 months following tooth extraction at a position located 2mm and 4mm vertically away from the height of the buccal bone plate. Data will be calculated using data from DICOM images acquired by CBCT and overlaid 3D scans of patient dental models using 3D software.
Mean Soft Tissue Dimensional Changes-Vertical
The amount of linear (mm) vertical soft tissue change at 3 months following tooth extraction at a position located mid-buccal, mid-palatal, mesial and distal of the extraction site. Data will be calculated using data from 3D scans of patient dental models using 3D software.
Soft Tissue Dimensional Change at Month 6
The amount of soft tissue change will be assessed through the use of dental casts at two time points following extraction and ridge preservation at 6 months.
Full Information
NCT ID
NCT02532543
First Posted
August 21, 2015
Last Updated
December 6, 2019
Sponsor
University of North Carolina, Chapel Hill
Collaborators
Dentsply International
1. Study Identification
Unique Protocol Identification Number
NCT02532543
Brief Title
Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials
Official Title
Prospective, Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials (SYMBIOS CORTICAL-CANCELLOUS GRANULE MIX; SYMBIOS OSTEOGRAF LD-300; OSTEOGRAF/N-300) Following Tooth Extraction
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Terminated
Why Stopped
Difficulty in recruitment
Study Start Date
April 2016 (Actual)
Primary Completion Date
February 12, 2018 (Actual)
Study Completion Date
February 12, 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of North Carolina, Chapel Hill
Collaborators
Dentsply International
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
This study is intended to provide statistically robust evidence that Symbios Demineralized Cortical-cancellous granule mix, Symbios OsteoGraf LD-300, and OsteoGraf/N-300 combined with Symbios OsteoShield Collagen Resorbable Membrane can adequately support the alveolus during ridge augmentation procedures, reducing the dimensional changes of both the alveolus and the overlying soft tissues. Additionally, a comparison between each material will be made, providing further evidence of each materials' ability to preserve the alveolus. It is intended to define in objective terms the response of the hard and soft tissues to ridge augmentation.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Tooth Fractures, Tooth Injuries, Tooth Diseases
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Group A- Allograft, Membrane
Arm Type
Active Comparator
Arm Description
Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Arm Title
Group B- Alloplast, Membrane
Arm Type
Active Comparator
Arm Description
Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
Arm Title
Group C- Xenograft, Membrane
Arm Type
Active Comparator
Arm Description
OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane
Arm Title
Group D- Membrane
Arm Type
Active Comparator
Arm Description
Symbios OsteoShield Collagen Resorbable Membrane
Intervention Type
Biological
Intervention Name(s)
Allograft, Membrane
Intervention Description
Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Intervention Type
Biological
Intervention Name(s)
Alloplast, Membrane
Intervention Description
Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
Intervention Type
Biological
Intervention Name(s)
Xenograft, Membrane
Intervention Description
Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane
Intervention Type
Biological
Intervention Name(s)
Membrane
Intervention Description
Membrane - Symbios OsteoShield Collagen Resorbable Membrane
Primary Outcome Measure Information:
Title
Total Mean Change in Bone Volume
Description
The change in bone volume at 3 months following extraction will be calculated using data from DICOM images acquired by Cone Beam Computed Tomography (CBCT) using 3D software
Time Frame
time of extraction to 3 months post extraction
Secondary Outcome Measure Information:
Title
Mean Osseous Dimensional Changes-Horizontal
Description
The amount of linear (mm) horizontal bone change at 3 months following tooth extraction at a position located 2mm and 4mm vertically away from the height of the buccal plate. Data will be calculated using data from DICOM images acquired by CBCT using 3D software.
Time Frame
time of extraction to 3 months post extraction
Title
Mean Osseous Dimensional Changes-Vertical
Description
The amount of linear (mm) vertical bone change at 3 months following tooth extraction at a position located mid-buccal, mid-palatal, mesial and distal of the extraction site. Data will be calculated using data from DICOM images acquired by CBCT using 3D software.
Time Frame
time of extraction to 3 months post extraction
Title
Total Mean Change in Soft Tissue Volume
Description
The change in soft tissue volume at 3 months following tooth extraction will be assessed through the use of 3D scans of patient dental models at two time points following extraction and ridge preservation at 3 months.
Time Frame
time of extraction to 3 months post extraction
Title
Mean Soft Tissue Dimensional Changes-Horizontal
Description
The amount of linear (mm) horizontal soft tissue change at 3 months following tooth extraction at a position located 2mm and 4mm vertically away from the height of the buccal bone plate. Data will be calculated using data from DICOM images acquired by CBCT and overlaid 3D scans of patient dental models using 3D software.
Time Frame
time of extraction to 3 months post extraction
Title
Mean Soft Tissue Dimensional Changes-Vertical
Description
The amount of linear (mm) vertical soft tissue change at 3 months following tooth extraction at a position located mid-buccal, mid-palatal, mesial and distal of the extraction site. Data will be calculated using data from 3D scans of patient dental models using 3D software.
Time Frame
time of extraction to 3 months post extraction
Title
Soft Tissue Dimensional Change at Month 6
Description
The amount of soft tissue change will be assessed through the use of dental casts at two time points following extraction and ridge preservation at 6 months.
Time Frame
Month 6
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
75 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria:
Provision of informed consent
≥ 18 years and ≤ 75 years
Good physical health (ASAI/II)
Extraction of maxillary premolar, canine or incisor, or mandibular premolar and canine required
Teeth adjacent (mesial and distal) to study site must consist of two stable natural teeth with minimal restorations, without signs of periodontal bone loss (> 3 mm) and/or significant soft tissue deficiencies
Exclusion Criteria:
Buccal plate dehiscence and/or fenestration >3mm at study site following extraction
Untreated rampant caries and uncontrolled periodontal disease
Inadequate oral hygiene (estimated plaque score >20%)
Smokers using more than 10 cigarettes or equivalent per day
Smokeless tobacco use or e-cigarette use
Compromised physical health and/or uncontrolled or severe systemic diseases including:
ASA III/IV Metabolic bone disease History of malignancy History or radiotherapy or chemotherapy for malignancy in the past 5 years History of autoimmune disease Long-term steroidal or antibiotic therapy Uncontrolled diabetes Known alcohol or drug abuse
Systemic or local disease or condition that would compromise post-operative healing
Use of any substance or medication that will influence bone metabolism
Known pregnancy
Unable or unwilling to return for follow-up visits for a period of 6 months
Unlikely to be able to comply with study procedures according to Investigators judgement
Involvement in the planning and conduct of the study
Previous enrollment or randomization of treatment in the present study
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jonathan Reside, DDS MS
Organizational Affiliation
Dept. of Periodontology
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of North Carolina School of Dentistry
City
Chapel Hill
State/Province
North Carolina
ZIP/Postal Code
27599
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
No
Citations:
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Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials
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