Tooth Diseases, Tooth Fractures, Tooth Injuries
Conditions
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.
Interventions
BIOLOGICALAllograft, Membrane
Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
BIOLOGICALAlloplast, Membrane
Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
BIOLOGICALXenograft, Membrane
Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane
BIOLOGICALMembrane
Membrane - Symbios OsteoShield Collagen Resorbable Membrane
Sponsors
Dentsply International
University of North Carolina, Chapel Hill
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 75 Years
Healthy volunteers
Yes
Inclusion criteria
1. Provision of informed consent 2. ≥ 18 years and ≤ 75 years 3. Good physical health (ASAI/II) 4. Extraction of maxillary premolar, canine or incisor, or mandibular premolar and canine required 5. 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
1. Buccal plate dehiscence and/or fenestration \>3mm at study site following extraction 2. Untreated rampant caries and uncontrolled periodontal disease 3. Inadequate oral hygiene (estimated plaque score \>20%) 4. Smokers using more than 10 cigarettes or equivalent per day 5. Smokeless tobacco use or e-cigarette use 6. 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 7. Systemic or local disease or condition that would compromise post-operative healing 8. Use of any substance or medication that will influence bone metabolism 9. Known pregnancy 10. Unable or unwilling to return for follow-up visits for a period of 6 months 11. Unlikely to be able to comply with study procedures according to Investigators judgement 12. Involvement in the planning and conduct of the study 13. Previous enrollment or randomization of treatment in the present study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Total Mean Change in Bone Volume | time of extraction to 3 months post extraction | 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
| Measure | Time frame | Description |
|---|---|---|
| Mean Osseous Dimensional Changes-Vertical | time of extraction to 3 months post extraction | 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 | time of extraction to 3 months post extraction | 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 Osseous Dimensional Changes-Horizontal | time of extraction to 3 months post extraction | 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 Soft Tissue Dimensional Changes-Vertical | time of extraction to 3 months post extraction | 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 | 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. |
| Mean Soft Tissue Dimensional Changes-Horizontal | time of extraction to 3 months post extraction | 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. |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Group A- Allograft, Membrane Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane
Allograft, Membrane: Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane | 3 |
| Group B- Alloplast, Membrane Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane
Alloplast, Membrane: Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane | 4 |
| Group C- Xenograft, Membrane OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane
Xenograft, Membrane: Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane | 5 |
| Group D- Membrane Symbios OsteoShield Collagen Resorbable Membrane
Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane | 4 |
| Total | 16 |
Withdrawals & dropouts
| Period | Reason | FG000 | FG001 | FG002 | FG003 |
|---|---|---|---|---|---|
| Overall Study | Lost to Follow-up | 0 | 0 | 1 | 0 |
Baseline characteristics
| Characteristic | Group B- Alloplast, Membrane | Group C- Xenograft, Membrane | Group D- Membrane | Total | Group A- Allograft, Membrane |
|---|---|---|---|---|---|
| Age, Continuous | 63.2 years STANDARD_DEVIATION 5.7 | 49.2 years STANDARD_DEVIATION 12.3 | 50.7 years STANDARD_DEVIATION 20.7 | 53.0 years STANDARD_DEVIATION 13.3 | 47.3 years STANDARD_DEVIATION 4.5 |
| Race and Ethnicity Not Collected | — | — | — | 0 Participants | — |
| Region of Enrollment United States | 4 Participants | 5 Participants | 4 Participants | 16 Participants | 3 Participants |
| Sex: Female, Male Female | 0 Participants | 3 Participants | 2 Participants | 6 Participants | 1 Participants |
| Sex: Female, Male Male | 4 Participants | 2 Participants | 2 Participants | 10 Participants | 2 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk | EG002 affected / at risk | EG003 affected / at risk |
|---|---|---|---|---|
| deaths Total, all-cause mortality | 0 / 3 | 0 / 4 | 0 / 5 | 0 / 4 |
| other Total, other adverse events | 0 / 3 | 0 / 4 | 0 / 5 | 0 / 4 |
| serious Total, serious adverse events | 0 / 3 | 0 / 4 | 0 / 5 | 0 / 4 |
Outcome results
Primary
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
Time frame: time of extraction to 3 months post extraction
Population: One participant was lost to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A- Allograft, Membrane | Total Mean Change in Bone Volume | -91.64 mm^3 | Standard Deviation 51.97 |
| Group B- Alloplast, Membrane | Total Mean Change in Bone Volume | -107.47 mm^3 | Standard Deviation 52.31 |
| Group C- Xenograft, Membrane | Total Mean Change in Bone Volume | -77.31 mm^3 | Standard Deviation 30.99 |
| Group D- Membrane | Total Mean Change in Bone Volume | -99.41 mm^3 | Standard Deviation 66 |
p-value: 0.863ANOVA
Secondary
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.
Time frame: time of extraction to 3 months post extraction
Population: One participant was lost to follow up. Measurements were taken at 2 and 4 mm instead of 3, 6 and 9 mm due to difficulties in data collection and patient variability
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A- Allograft, Membrane | Mean Osseous Dimensional Changes-Horizontal | 2 mm from height of crest | -0.87 mm | Standard Deviation 0.98 |
| Group A- Allograft, Membrane | Mean Osseous Dimensional Changes-Horizontal | 4 mm from height of crest | -1.03 mm | Standard Deviation 0.8 |
| Group B- Alloplast, Membrane | Mean Osseous Dimensional Changes-Horizontal | 4 mm from height of crest | -0.47 mm | Standard Deviation 0.57 |
| Group B- Alloplast, Membrane | Mean Osseous Dimensional Changes-Horizontal | 2 mm from height of crest | -1.30 mm | Standard Deviation 0.74 |
| Group C- Xenograft, Membrane | Mean Osseous Dimensional Changes-Horizontal | 2 mm from height of crest | -1.77 mm | Standard Deviation 0.42 |
| Group C- Xenograft, Membrane | Mean Osseous Dimensional Changes-Horizontal | 4 mm from height of crest | -0.92 mm | Standard Deviation 0.75 |
| Group D- Membrane | Mean Osseous Dimensional Changes-Horizontal | 2 mm from height of crest | -1.62 mm | Standard Deviation 1.75 |
| Group D- Membrane | Mean Osseous Dimensional Changes-Horizontal | 4 mm from height of crest | -0.97 mm | Standard Deviation 1.48 |
Comparison: Comparison between each arm/group at 2 mm from the height of the bone crestp-value: 0.718ANOVA
Comparison: Comparison between each arm/group at 4 mm from the height of the bone crestp-value: 0.853ANOVA
Secondary
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.
Time frame: time of extraction to 3 months post extraction
Population: One participant was lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A- Allograft, Membrane | Mean Osseous Dimensional Changes-Vertical | Mid Buccal | -1.23 mm | Standard Deviation 1.04 |
| Group A- Allograft, Membrane | Mean Osseous Dimensional Changes-Vertical | Mid Palatal | -1.00 mm | Standard Deviation 0.4 |
| Group A- Allograft, Membrane | Mean Osseous Dimensional Changes-Vertical | Mesial | -1.47 mm | Standard Deviation 0.55 |
| Group A- Allograft, Membrane | Mean Osseous Dimensional Changes-Vertical | Distal | -1.07 mm | Standard Deviation 0.25 |
| Group B- Alloplast, Membrane | Mean Osseous Dimensional Changes-Vertical | Mid Palatal | -1.02 mm | Standard Deviation 0.39 |
| Group B- Alloplast, Membrane | Mean Osseous Dimensional Changes-Vertical | Mesial | -0.87 mm | Standard Deviation 0.69 |
| Group B- Alloplast, Membrane | Mean Osseous Dimensional Changes-Vertical | Distal | -0.55 mm | Standard Deviation 0.46 |
| Group B- Alloplast, Membrane | Mean Osseous Dimensional Changes-Vertical | Mid Buccal | -1.77 mm | Standard Deviation 1.58 |
| Group C- Xenograft, Membrane | Mean Osseous Dimensional Changes-Vertical | Mesial | -0.65 mm | Standard Deviation 1.14 |
| Group C- Xenograft, Membrane | Mean Osseous Dimensional Changes-Vertical | Mid Palatal | -0.97 mm | Standard Deviation 0.46 |
| Group C- Xenograft, Membrane | Mean Osseous Dimensional Changes-Vertical | Distal | -0.60 mm | Standard Deviation 1.07 |
| Group C- Xenograft, Membrane | Mean Osseous Dimensional Changes-Vertical | Mid Buccal | -2.00 mm | Standard Deviation 1.15 |
| Group D- Membrane | Mean Osseous Dimensional Changes-Vertical | Distal | -0.90 mm | Standard Deviation 0.62 |
| Group D- Membrane | Mean Osseous Dimensional Changes-Vertical | Mid Palatal | -1.02 mm | Standard Deviation 0.82 |
| Group D- Membrane | Mean Osseous Dimensional Changes-Vertical | Mid Buccal | -2.92 mm | Standard Deviation 3.14 |
| Group D- Membrane | Mean Osseous Dimensional Changes-Vertical | Mesial | -1.60 mm | Standard Deviation 1.02 |
Comparison: Comparison between each arm/group of change in mid buccal bone heightp-value: 0.718ANOVA
Comparison: Comparison between each arm/group of change in mid palatal bone heightp-value: 0.999ANOVA
Comparison: Comparison between each arm/group of change in mesial bone heightp-value: 0.44ANOVA
Comparison: Comparison between each arm/group of change in distal bone heightp-value: 0.729ANOVA
Secondary
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.
Time frame: time of extraction to 3 months post extraction
Population: One participant was lost to follow up. Measurements were taken at 2 and 4 mm instead of 3, 6 and 9 mm due to difficulties in data collection and patient variability
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A- Allograft, Membrane | Mean Soft Tissue Dimensional Changes-Horizontal | 2 mm from height of crest | -0.47 mm | Standard Deviation 0.47 |
| Group A- Allograft, Membrane | Mean Soft Tissue Dimensional Changes-Horizontal | 4 mm from height of crest | -0.40 mm | Standard Deviation 0.28 |
| Group B- Alloplast, Membrane | Mean Soft Tissue Dimensional Changes-Horizontal | 4 mm from height of crest | -0.37 mm | Standard Deviation 0.25 |
| Group B- Alloplast, Membrane | Mean Soft Tissue Dimensional Changes-Horizontal | 2 mm from height of crest | -0.67 mm | Standard Deviation 0.48 |
| Group C- Xenograft, Membrane | Mean Soft Tissue Dimensional Changes-Horizontal | 2 mm from height of crest | -1.30 mm | Standard Deviation 0.82 |
| Group C- Xenograft, Membrane | Mean Soft Tissue Dimensional Changes-Horizontal | 4 mm from height of crest | -0.70 mm | Standard Deviation 0.47 |
| Group D- Membrane | Mean Soft Tissue Dimensional Changes-Horizontal | 2 mm from height of crest | -0.87 mm | Standard Deviation 0.95 |
| Group D- Membrane | Mean Soft Tissue Dimensional Changes-Horizontal | 4 mm from height of crest | -0.50 mm | Standard Deviation 1.14 |
Comparison: Comparison between each arm/group at 2 mm from the height of the bone crestp-value: 0.492ANOVA
Comparison: Comparison between each arm/group at 4 mm from the height of the bone crestp-value: 0.917ANOVA
Secondary
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.
Time frame: time of extraction to 3 months post extraction
Population: One participant was lost to follow up.
| Arm | Measure | Group | Value (MEAN) | Dispersion |
|---|---|---|---|---|
| Group A- Allograft, Membrane | Mean Soft Tissue Dimensional Changes-Vertical | Mid Buccal | -1.60 mm | Standard Deviation 1.15 |
| Group A- Allograft, Membrane | Mean Soft Tissue Dimensional Changes-Vertical | Mid Palatal | -1.20 mm | Standard Deviation 0.36 |
| Group A- Allograft, Membrane | Mean Soft Tissue Dimensional Changes-Vertical | Mesial | -1.30 mm | Standard Deviation 1.04 |
| Group A- Allograft, Membrane | Mean Soft Tissue Dimensional Changes-Vertical | Distal | -1.53 mm | Standard Deviation 1 |
| Group B- Alloplast, Membrane | Mean Soft Tissue Dimensional Changes-Vertical | Mid Palatal | -1.00 mm | Standard Deviation 0.29 |
| Group B- Alloplast, Membrane | Mean Soft Tissue Dimensional Changes-Vertical | Mesial | -1.02 mm | Standard Deviation 0.45 |
| Group B- Alloplast, Membrane | Mean Soft Tissue Dimensional Changes-Vertical | Distal | -1.05 mm | Standard Deviation 0.66 |
| Group B- Alloplast, Membrane | Mean Soft Tissue Dimensional Changes-Vertical | Mid Buccal | -1.80 mm | Standard Deviation 0.62 |
| Group C- Xenograft, Membrane | Mean Soft Tissue Dimensional Changes-Vertical | Mesial | -0.52 mm | Standard Deviation 0.59 |
| Group C- Xenograft, Membrane | Mean Soft Tissue Dimensional Changes-Vertical | Mid Palatal | -1.02 mm | Standard Deviation 0.68 |
| Group C- Xenograft, Membrane | Mean Soft Tissue Dimensional Changes-Vertical | Distal | -1.12 mm | Standard Deviation 0.89 |
| Group C- Xenograft, Membrane | Mean Soft Tissue Dimensional Changes-Vertical | Mid Buccal | -1.72 mm | Standard Deviation 0.51 |
| Group D- Membrane | Mean Soft Tissue Dimensional Changes-Vertical | Distal | -1.47 mm | Standard Deviation 0.32 |
| Group D- Membrane | Mean Soft Tissue Dimensional Changes-Vertical | Mid Palatal | -1.30 mm | Standard Deviation 0.58 |
| Group D- Membrane | Mean Soft Tissue Dimensional Changes-Vertical | Mid Buccal | -2.95 mm | Standard Deviation 1.75 |
| Group D- Membrane | Mean Soft Tissue Dimensional Changes-Vertical | Mesial | -1.37 mm | Standard Deviation 0.15 |
Comparison: Comparison between each arm/group of change in mid buccal soft tissue heightp-value: 0.353ANOVA
Comparison: Comparison between each arm/group of change in mid palatal soft tissue heightp-value: 0.823ANOVA
Comparison: Comparison between each arm/group of change in mesial soft tissue heightp-value: 0.243ANOVA
Comparison: Comparison between each arm/group of change in distal soft tissue heightp-value: 0.756ANOVA
Secondary
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.
Time frame: Month 6
Population: Data for the Month 6 timepoint was not collected
Secondary
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.
Time frame: time of extraction to 3 months post extraction
Population: One participant was lost to follow up.
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Group A- Allograft, Membrane | Total Mean Change in Soft Tissue Volume | -99.44 mm^3 | Standard Deviation 48.93 |
| Group B- Alloplast, Membrane | Total Mean Change in Soft Tissue Volume | -81.24 mm^3 | Standard Deviation 13.24 |
| Group C- Xenograft, Membrane | Total Mean Change in Soft Tissue Volume | -82.71 mm^3 | Standard Deviation 23.15 |
| Group D- Membrane | Total Mean Change in Soft Tissue Volume | -107.59 mm^3 | Standard Deviation 38.59 |
p-value: 0.613ANOVA