drugset / Trial / NCT02532543
Comparative Volumetric Assessment of Alveolar Ridge Preservation Utilizing Different Bone Grafting Materials
RandomizedParallel-groupOpen-labelTreatment
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.
Timeline
- Start
- 2016-04
- Primary completion
- 2018-02-12
- Completion
- 2018-02-12
Outcome
Outcome not reported
Stopped (Enrollment): “Difficulty in recruitment”
Publications
- 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.
- 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.
- 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.
- 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.
- Background Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:260-71.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
- 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.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Comparator | OsteoGraf/N-300 | Unknown | — | — |
| Comparator | Symbios OsteoGraf/LD-300 | Unknown | — | — |
| Comparator | Symbios mineralized cortical-cancellous granule mix | Unknown | — | — |
| Comparator | Symbios OsteoShield Collagen Resorbable Membrane | Unknown | — | — |