Tooth Extraction Clinical Trial
Official title:
Evaluation of Healing at Molar Extraction Sites With Ridge Preservation Using Freeze Dried Bone Allograft and a Collagen Wound Dressing
Verified date | April 2018 |
Source | The University of Texas Health Science Center at San Antonio |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
Currently, it is not known what the dimensional changes might be following a molar site
extraction which has been grafted with FDBA and covered with a collagen wound dressing. The
purpose of the proposed study is to examine the clinical healing following ridge preservation
using freeze dried bone allograft (FDBA) with a collagen wound dressing barrier (CollaPlug®)
in a molar extraction site.
I
Status | Completed |
Enrollment | 27 |
Est. completion date | April 6, 2018 |
Est. primary completion date | April 6, 2018 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years to 99 Years |
Eligibility |
Inclusion Criteria: - One molar tooth that has been identified by dental faculty as requiring a single tooth extraction - A dental implant is indicated and treatment planned to replace the missing molar tooth - Have adequate restorative space for a dental implant-retained restoration - Have at least 10mm of alveolar bone height, without impinging on the maxillary sinus or inferior alveolar canal. Exclusion Criteria: - Patients will not be entered who are mentally incompetent, prisoners, or pregnant. - Pregnant women or women intending to become pregnant during the study period. - Patients who become pregnant during the study will be withdrawn and standard care will be delivered. - Clinical and/or radiographic determinations which will preclude inclusion in this study are: 1. Active localized or systemic infection other than periodontitis. 2. Untreated periodontal diseases 3. Inadequate bone dimensions or restorative space dimensions to place a dental implant 4. Presence of a disease entity, medical condition or therapeutic regimen which decreases probability of soft tissue and bony healing, e.g., poorly controlled diabetes, chemotherapeutic and immunosuppressive agents, or autoimmune diseases. 5. Positive medical history of endocarditis following oral or dental surgery. |
Country | Name | City | State |
---|---|---|---|
n/a |
Lead Sponsor | Collaborator |
---|---|
The University of Texas Health Science Center at San Antonio |
Araújo MG, Lindhe J. Dimensional ridge alterations following tooth extraction. An experimental study in the dog. J Clin Periodontol. 2005 Feb;32(2):212-8. — View Citation
Araújo MG, Lindhe J. Ridge preservation with the use of Bio-Oss collagen: A 6-month study in the dog. Clin Oral Implants Res. 2009 May;20(5):433-40. doi: 10.1111/j.1600-0501.2009.01705.x. — View Citation
Barone A, Aldini NN, Fini M, Giardino R, Calvo Guirado JL, Covani U. Xenograft versus extraction alone for ridge preservation after tooth removal: a clinical and histomorphometric study. J Periodontol. 2008 Aug;79(8):1370-7. doi: 10.1902/jop.2008.070628 . — View Citation
Braut V, Bornstein MM, Lauber R, Buser D. Bone dimensions in the posterior mandible: a retrospective radiographic study using cone beam computed tomography. Part 1--analysis of dentate sites. Int J Periodontics Restorative Dent. 2012 Apr;32(2):175-84. — View Citation
Brownfield LA, Weltman RL. Ridge preservation with or without an osteoinductive allograft: a clinical, radiographic, micro-computed tomography, and histologic study evaluating dimensional changes and new bone formation of the alveolar ridge. J Periodontol. 2012 May;83(5):581-9. doi: 10.1902/jop.2011.110365. Epub 2011 Sep 26. — View Citation
Darby I, Chen ST, Buser D. Ridge preservation techniques for implant therapy. Int J Oral Maxillofac Implants. 2009;24 Suppl:260-71. Review. — View Citation
Ferrus J, Cecchinato D, Pjetursson EB, Lang NP, Sanz M, Lindhe J. Factors influencing ridge alterations following immediate implant placement into extraction sockets. Clin Oral Implants Res. 2010 Jan;21(1):22-9. doi: 10.1111/j.1600-0501.2009.01825.x. Epub 2009 Nov 13. — View Citation
Huynh-Ba G, Pjetursson BE, Sanz M, Cecchinato D, Ferrus J, Lindhe J, Lang NP. Analysis of the socket bone wall dimensions in the upper maxilla in relation to immediate implant placement. Clin Oral Implants Res. 2010 Jan;21(1):37-42. doi: 10.1111/j.1600-0501.2009.01870.x. — View Citation
Iasella JM, Greenwell H, Miller RL, Hill M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol. 2003 Jul;74(7):990-9. — View Citation
Nevins M, Camelo M, De Paoli S, Friedland B, Schenk RK, Parma-Benfenati S, Simion M, Tinti C, Wagenberg B. A study of the fate of the buccal wall of extraction sockets of teeth with prominent roots. Int J Periodontics Restorative Dent. 2006 Feb;26(1):19-29. — View Citation
Oghli AA, Steveling H. Ridge preservation following tooth extraction: a comparison between atraumatic extraction and socket seal surgery. Quintessence Int. 2010 Jul-Aug;41(7):605-9. — View Citation
Spray JR, Black CG, Morris HF, Ochi S. The influence of bone thickness on facial marginal bone response: stage 1 placement through stage 2 uncovering. Ann Periodontol. 2000 Dec;5(1):119-28. — View Citation
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. Review. — View Citation
Van der Weijden F, Dell'Acqua F, Slot DE. Alveolar bone dimensional changes of post-extraction sockets in humans: a systematic review. J Clin Periodontol. 2009 Dec;36(12):1048-58. doi: 10.1111/j.1600-051X.2009.01482.x. Review. — View Citation
Vignoletti F, Matesanz P, Rodrigo D, Figuero E, Martin C, Sanz M. Surgical protocols for ridge preservation after tooth extraction. A systematic review. Clin Oral Implants Res. 2012 Feb;23 Suppl 5:22-38. doi: 10.1111/j.1600-0501.2011.02331.x. Review. — View Citation
* Note: There are 15 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Radiographic bone width changes (in mm) | Following extraction and ridge preservation the alveolar bone around the extraction socket will remodel and some resorption is expected. Alveolar ridge width change (in mm) at the extraction site will be recorded by means of Cone Beam Computed Tomography (CBCT) | 3 months | |
Secondary | Radiographic bone height changes (in mm) | Following extraction and ridge preservation the alveolar bone around the extraction socket will remodel and some resorption is expected. Alveolar ridge height change (in mm) at the extraction site will be recorded by means of Cone Beam Computed Tomography (CBCT) | 3 months |
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