Not provided
Not provided
Not provided
Not provided
Not provided
Difficulty in recruitment
Not provided
Not provided
Not provided
Not provided
| Name | Class |
|---|---|
| Dentsply International | INDUSTRY |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Group A- Allograft, Membrane | Active Comparator | Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane |
|
| Group B- Alloplast, Membrane | Active Comparator | Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane |
|
| Group C- Xenograft, Membrane | Active Comparator | OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane |
|
| Group D- Membrane | Active Comparator | Symbios OsteoShield Collagen Resorbable Membrane |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Allograft, Membrane | Biological | Allograft, Membrane- Symbios mineralized cortical-cancellous granule mix, Symbios OsteoShield Collagen Resorbable Membrane |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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 of extraction to 3 months post extraction |
| Measure | Description | Time Frame |
|---|---|---|
| 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 of extraction to 3 months post extraction |
Not provided
Inclusion Criteria:
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
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jonathan Reside, DDS MS | Dept. of Periodontology | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University of North Carolina School of Dentistry | Chapel Hill | North Carolina | 27599 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12956475 | Background | Schropp L, Wenzel A, Kostopoulos L, Karring T. Bone healing and soft tissue contour changes following single-tooth extraction: a clinical and radiographic 12-month prospective study. Int J Periodontics Restorative Dent. 2003 Aug;23(4):313-23. | |
| 22211303 | Background | Tan WL, Wong TL, Wong MC, Lang NP. A systematic review of post-extractional alveolar hard and soft tissue dimensional changes in humans. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:1-21. doi: 10.1111/j.1600-0501.2011.02375.x. |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| ID | Title | Description |
|---|---|---|
| FG000 | 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 |
| FG001 | Group B- Alloplast, Membrane |
| Title | Milestones | Reasons Not Completed | |||||
|---|---|---|---|---|---|---|---|
| Overall Study |
|
Not provided
Not provided
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot_SAP | Yes | Yes | No | Study Protocol and Statistical Analysis Plan | Oct 4, 2016 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Alloplast, Membrane | Biological | Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane |
|
| Xenograft, Membrane | Biological | Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane |
|
| Membrane | Biological | Membrane - Symbios OsteoShield Collagen Resorbable Membrane |
|
| 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 of extraction to 3 months post extraction |
| 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 of extraction to 3 months post extraction |
| 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 of extraction to 3 months post extraction |
| 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 of extraction to 3 months post extraction |
| 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. | Month 6 |
| 15691354 | Background | Araujo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. doi: 10.1111/j.1600-051X.2005.00642.x. |
| 21091540 | Background | Ten Heggeler JM, Slot DE, Van der Weijden GA. Effect of socket preservation therapies following tooth extraction in non-molar regions in humans: a systematic review. Clin Oral Implants Res. 2011 Aug;22(8):779-88. doi: 10.1111/j.1600-0501.2010.02064.x. Epub 2010 Nov 22. |
| 19885449 | Background | Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:260-71. |
| 21707753 | Background | Fienitz T, Schwarz F, Ritter L, Dreiseidler T, Becker J, Rothamel D. Accuracy of cone beam computed tomography in assessing peri-implant bone defect regeneration: a histologically controlled study in dogs. Clin Oral Implants Res. 2012 Jul;23(7):882-7. doi: 10.1111/j.1600-0501.2011.02232.x. Epub 2011 Jun 24. |
| 18384410 | Background | Veyre-Goulet S, Fortin T, Thierry A. Accuracy of linear measurement provided by cone beam computed tomography to assess bone quantity in the posterior maxilla: a human cadaver study. Clin Implant Dent Relat Res. 2008 Dec;10(4):226-30. doi: 10.1111/j.1708-8208.2008.00083.x. Epub 2008 Apr 1. |
| 20630297 | Background | Kim TS, Caruso JM, Christensen H, Torabinejad M. A comparison of cone-beam computed tomography and direct measurement in the examination of the mandibular canal and adjacent structures. J Endod. 2010 Jul;36(7):1191-4. doi: 10.1016/j.joen.2010.03.028. |
| 23513204 | Background | Pertl L, Gashi-Cenkoglu B, Reichmann J, Jakse N, Pertl C. Preoperative assessment of the mandibular canal in implant surgery: comparison of rotational panoramic radiography (OPG), computed tomography (CT) and cone beam computed tomography (CBCT) for preoperative assessment in implant surgery. Eur J Oral Implantol. 2013 Spring;6(1):73-80. |
| 21697155 | Background | Ganguly R, Ruprecht A, Vincent S, Hellstein J, Timmons S, Qian F. Accuracy of linear measurement in the Galileos cone beam computed tomography under simulated clinical conditions. Dentomaxillofac Radiol. 2011 Jul;40(5):299-305. doi: 10.1259/dmfr/72117593. |
| 22668710 | Background | Tyndall DA, Price JB, Tetradis S, Ganz SD, Hildebolt C, Scarfe WC; American Academy of Oral and Maxillofacial Radiology. Position statement of the American Academy of Oral and Maxillofacial Radiology on selection criteria for the use of radiology in dental implantology with emphasis on cone beam computed tomography. Oral Surg Oral Med Oral Pathol Oral Radiol. 2012 Jun;113(6):817-26. doi: 10.1016/j.oooo.2012.03.005. |
| 23457068 | Background | Watters W 3rd, Rethman MP, Hanson NB, Abt E, Anderson PA, Carroll KC, Futrell HC, Garvin K, Glenn SO, Hellstein J, Hewlett A, Kolessar D, Moucha C, O'Donnell RJ, O'Toole JE, Osmon DR, Evans RP, Rinella A, Steinberg MJ, Goldberg M, Ristic H, Boyer K, Sluka P, Martin WR 3rd, Cummins DS, Song S, Woznica A, Gross L; American Academy of Orthopedic Surgeons; American Dental Association. Prevention of Orthopaedic Implant Infection in Patients Undergoing Dental Procedures. J Am Acad Orthop Surg. 2013 Mar;21(3):180-9. doi: 10.5435/JAAOS-21-03-180. |
| 24155583 | Background | Kurien S, Kattimani VS, Sriram RR, Sriram SK, Rao V K P, Bhupathi A, Bodduru RR, N Patil N. Management of pregnant patient in dentistry. J Int Oral Health. 2013 Feb;5(1):88-97. Epub 2013 Feb 26. |
Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane Alloplast, Membrane: Alloplast, Membrane- Symbios OsteoGraf/LD-300, Symbios OsteoShield Collagen Resorbable Membrane |
| FG002 | Group C- Xenograft, Membrane | OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane Xenograft, Membrane: Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane |
| FG003 | Group D- Membrane | Symbios OsteoShield Collagen Resorbable Membrane Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane |
| COMPLETED |
|
| NOT COMPLETED |
|
|
Not provided
| ID | Title | Description |
|---|---|---|
| BG000 | 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 |
| BG001 | 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 |
| BG002 | Group C- Xenograft, Membrane | OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane Xenograft, Membrane: Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane |
| BG003 | Group D- Membrane | Symbios OsteoShield Collagen Resorbable Membrane Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane |
| BG004 | Total | Total of all reporting groups |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes | |||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Age, Continuous | Mean | Standard Deviation | years |
| ||||||||||
| Sex: Female, Male | Count of Participants | Participants |
| |||||||||||
| Race and Ethnicity Not Collected | Race and Ethnicity were not collected from any participant. | Count of Participants | Participants |
| ||||||||||
| Region of Enrollment | Count of Participants | Participants |
|
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| 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 | One participant was lost to follow up. | Posted | Mean | Standard Deviation | mm^3 | time of extraction to 3 months post extraction |
|
|
|
| |||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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 | Posted | Mean | Standard Deviation | mm | time of extraction to 3 months post extraction |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | One participant was lost to follow up. | Posted | Mean | Standard Deviation | mm | time of extraction to 3 months post extraction |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | One participant was lost to follow up. | Posted | Mean | Standard Deviation | mm^3 | time of extraction to 3 months post extraction |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | 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 | Posted | Mean | Standard Deviation | mm | time of extraction to 3 months post extraction |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | One participant was lost to follow up. | Posted | Mean | Standard Deviation | mm | time of extraction to 3 months post extraction |
| ||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||||
| 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. | Data for the Month 6 timepoint was not collected | Posted | Month 6 |
|
From the signing of the Informed Consent form until study completion, a total of approximately 3 months
Not provided
Not provided
| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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 | 0 | 3 | 0 | 3 | 0 | 3 |
| EG001 | 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 | 0 | 4 | 0 | 4 | 0 | 4 |
| EG002 | Group C- Xenograft, Membrane | OsteoGraf/N-300 , Symbios OsteoShield Collagen Resorbable Membrane Xenograft, Membrane: Xenograft, Membrane- OsteoGraf/N-300,Symbios OsteoShield Collagen Resorbable Membrane | 0 | 5 | 0 | 5 | 0 | 5 |
| EG003 | Group D- Membrane | Symbios OsteoShield Collagen Resorbable Membrane Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane | 0 | 4 | 0 | 4 | 0 | 4 |
Not provided
Not provided
Not provided
Not provided
Not provided
| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Gidgetta Kang | University of North Carolina at Chapel Hill | 919-537-3968 | gidgetta_jenkins@unc.edu |
| Nov 1, 2019 |
| Prot_SAP_000.pdf |
| ID | Term |
|---|---|
| D014082 | Tooth Fractures |
| D018677 | Tooth Injuries |
| D014076 | Tooth Diseases |
| ID | Term |
|---|---|
| D009057 | Stomatognathic Diseases |
| D014947 | Wounds and Injuries |
Not provided
Not provided
| ID | Term |
|---|---|
| D014184 | Transplantation, Homologous |
| D014183 | Transplantation, Heterologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
Not provided
Not provided
|
|
|
|
| OG003 | Group D- Membrane | Symbios OsteoShield Collagen Resorbable Membrane Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane |
|
|
|
| OG003 | Group D- Membrane | Symbios OsteoShield Collagen Resorbable Membrane Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane |
|
|
|
| OG003 |
| Group D- Membrane |
Symbios OsteoShield Collagen Resorbable Membrane Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane |
|
|
|
| OG003 | Group D- Membrane | Symbios OsteoShield Collagen Resorbable Membrane Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane |
|
|
|
| OG003 | Group D- Membrane | Symbios OsteoShield Collagen Resorbable Membrane Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane |
|
|
|
Symbios OsteoShield Collagen Resorbable Membrane Membrane: Membrane - Symbios OsteoShield Collagen Resorbable Membrane |
|