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| Name | Class |
|---|---|
| Osteo Science Foundation | UNKNOWN |
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This study is designed to assess the effects of Alveolar Ridge Preservation (ARP) after tooth extraction compared to extraction alone in the posterior maxilla. The results of this study will demonstrate if the use of ARP reduces alveolar ridge resorption at 6 months post extraction in the posterior maxilla region.
Fifteen subjects requiring extraction of one posterior tooth in the right maxilla and one posterior tooth in the left maxilla will be considered for enrollment. Subjects who meet the inclusion and exclusion criteria will be randomized to receive alveolar ridge preservation on one side of the maxilla and only an extraction on the other side of the maxilla.
Extraction of the failing teeth will be performed atraumatically; a mucoperiosteal flap will not be employed. After removal of the tooth, the alveolus will be meticulously debrided and cleaned. In the test site, the socket will be filled with xenograft and a collagen membrane. In the control site, no graft material or collagen membrane will be used. Clinical measurements, standardized peri-apical radiographs and Cone Beam Computed Tomography scans will be performed immediately following tooth extractions (visit 2) and 6 months (visit 4) after extractions.
Subjects will be examined over the course of 6 months. Investigators will be trained prior to participating in the study. Training will be undertaken during a site initiation visit and will include a detailed description of all study procedures including treatment methods, and measurement methods to obtain study endpoints.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| No Treatment | No Intervention | Tooth extraction with no bone graft. | |
| Alveolar Ridge Preservation Treatment | Active Comparator | Tooth extraction followed by alveolar ridge preservation using xenograft bone graft and covered by a resorbable collagen membrane. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Xenograft | Device |
|
| Measure | Description | Time Frame |
|---|---|---|
| Changes in the bucco-palatal width of the alveolar ridge measured in mm. | Changes in the bucco-palatal width of alveolar ridge from baseline to 6 months, measured using CBCT data. | 6 Months |
| Changes in the vertical height of the alveolar ridge measured in mm. | Changes in the vertical height of the alveolar ridge measured using Cone Beam Computed Tomography (CBCT) data and periapical radiographs. | 6 Months |
| Measure | Description | Time Frame |
|---|---|---|
| Alveolar bone volumetric changes measured in mm. | Alveolar bone volumetric changes measured using CBCT data and from dental impressions. | 6 Months |
| Changes in the distance from the alveolar crestal bone to the sinus floor measured in mm. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Ismael E. Khouly, DDS, MS, PhD | Bluestone Center for Clinical Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Bluestone Center for Clinical Research | New York | New York | 10010 | United States |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 20070748 | Background | Araujo MG, Liljenberg B, Lindhe J. Dynamics of Bio-Oss Collagen incorporation in fresh extraction wounds: an experimental study in the dog. Clin Oral Implants Res. 2010 Jan;21(1):55-64. doi: 10.1111/j.1600-0501.2009.01854.x. | |
| 21091539 | Background | Araujo MG, Lindhe J. Socket grafting with the use of autologous bone: an experimental study in the dog. Clin Oral Implants Res. 2011 Jan;22(1):9-13. doi: 10.1111/j.1600-0501.2010.01937.x. Epub 2010 Nov 22. |
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| Type | Date | Date Unknown |
|---|---|---|
| Release | Apr 13, 2023 | |
| Reset | May 5, 2023 | |
| Release | Nov 7, 2023 | |
| Reset | Nov 29, 2023 |
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| Release Date | Unrelease Date | Unrelease Date Unknown | Reset Date | MCP Release Number |
|---|---|---|---|---|
| Apr 13, 2023 | May 5, 2023 | |||
| Nov 7, 2023 |
| ID | Term |
|---|---|
| D014183 | Transplantation, Heterologous |
| ID | Term |
|---|---|
| D014180 | Transplantation |
| D013514 | Surgical Procedures, Operative |
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Changes in the distance from the alveolar crestal bone to the sinus floor using CBCT data and standardized periapical radiographs.
| 6 months |
| Bone density changes from measured in mm. | Bone density changes measured using CBCT data. | 6 Months |
| Changes in keratinized mucosa width and thickness measured in mm. | Changes in keratinized mucosa width and thickness. | 6 months |
| Correlation of soft tissue and buccal bone wall thickness measured in mm. | Correlation of soft tissue and buccal bone wall thickness on radiographic outcomes. | 6 months |
| Subject satisfaction will be assessed through questionnaire. | Subject satisfaction will be assessed using a Visual Analogue Scale (VAS) (scored from 0-100) after extraction (visit 2), at 2 weeks (visit 3) and 6 months (visit 4) following tooth extractions. | 6 Months |
| Need for additional bone augmentation, including sinus bone augmentation measured in mm. | Need for additional bone augmentation, including sinus bone augmentation, prior to implant placement at 6 months post extractions | 1.5 Years |
| Implant success rate measured by percentage. | Evaluate dental implant success, in case the subject receives dental implant following healing of alveolar ridge after teeth extractions | 6 Months |
| 12656871 | Background | Carmagnola D, Adriaens P, Berglundh T. Healing of human extraction sockets filled with Bio-Oss. Clin Oral Implants Res. 2003 Apr;14(2):137-43. doi: 10.1034/j.1600-0501.2003.140201.x. |
| 11307396 | Background | Ashman A. Postextraction ridge preservation using a synthetic alloplast. Implant Dent. 2000;9(2):168-76. doi: 10.1097/00008505-200009020-00011. |
| 26020735 | Background | Atieh MA, Alsabeeha NH, Payne AG, Duncan W, Faggion CM, Esposito M. Interventions for replacing missing teeth: alveolar ridge preservation techniques for dental implant site development. Cochrane Database Syst Rev. 2015 May 28;2015(5):CD010176. doi: 10.1002/14651858.CD010176.pub2. |
| 24966231 | Background | Avila-Ortiz G, Elangovan S, Kramer KW, Blanchette D, Dawson DV. Effect of alveolar ridge preservation after tooth extraction: a systematic review and meta-analysis. J Dent Res. 2014 Oct;93(10):950-8. doi: 10.1177/0022034514541127. Epub 2014 Jun 25. |
| 11077380 | Background | Camargo PM, Lekovic V, Weinlaender M, Klokkevold PR, Kenney EB, Dimitrijevic B, Nedic M, Jancovic S, Orsini M. Influence of bioactive glass on changes in alveolar process dimensions after exodontia. Oral Surg Oral Med Oral Pathol Oral Radiol Endod. 2000 Nov;90(5):581-6. doi: 10.1067/moe.2000.110035. |
| 2987474 | Background | Greenstein G, Jaffin RA, Hilsen KL, Berman CL. Repair of anterior gingival deformity with durapatite. A case report. J Periodontol. 1985 Apr;56(4):200-3. doi: 10.1902/jop.1985.56.4.200. |
| 11958408 | Background | Norton MR, Wilson J. Dental implants placed in extraction sites implanted with bioactive glass: human histology and clinical outcome. Int J Oral Maxillofac Implants. 2002 Mar-Apr;17(2):249-57. |
| 20386783 | Background | Rasperini G, Canullo L, Dellavia C, Pellegrini G, Simion M. Socket grafting in the posterior maxilla reduces the need for sinus augmentation. Int J Periodontics Restorative Dent. 2010 Jun;30(3):265-73. |
| 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. |
| 285263 | Background | Soehren SE, Van Swol RL. The healing extraction site: a donor area for periodontal grafting material. J Periodontol. 1979 Mar;50(3):128-33. doi: 10.1902/jop.1979.50.3.128. |
| Nov 29, 2023 |