Alveolar Bone Resorption Clinical Trial
Official title:
Ridge Preservation Comparing the Clinical and Histologic Healing of Two Different Putty Bone Grafts
The primary aims of this study are to compare, after 4 months, the clinical and histologic results of a combination demineralized/mineralized putty allograft vs. synthetic calcium phosphosilicate (CPS) putty alloplast graft utilization in socket preservation procedures. A regenerative tissue matrix membrane will be used to cover each graft lying below the flap.
Status | Recruiting |
Enrollment | 30 |
Est. completion date | October 30, 2024 |
Est. primary completion date | October 7, 2024 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 18 Years and older |
Eligibility | Inclusion Criteria: 1. Have one non-molar tooth requiring extraction that will be replaced by a dental implant. The site must be bordered by at least one tooth. 2. Healthy male or female who is at least 18 years old. 3. Patients must sign an informed consent approved by the University of Louisville Human Studies Committee. Exclusion Criteria: 1. Patients with debilitating systemic diseases, or diseases that have a clinically significant effect on the periodontium. 2. Presence or history of osteonecrosis of jaws. 3. Patients who are currently taking IV bisphosphonates or who had IV treatment with bisphosphonates irrespective of duration. 4. Patients who have been treated with oral bisphosphonates for more than three years. 5. Patients with an allergy to any material or medication used in the study. 6. Patients who need prophylactic antibiotics 7. Previous head and neck radiation therapy. 8. Chemotherapy in the previous 12 months. 9. Patients on long term NSAID or steroid therapy. 10. Pregnant patients. |
Country | Name | City | State |
---|---|---|---|
United States | University of Louisville | Louisville | Kentucky |
Lead Sponsor | Collaborator |
---|---|
University of Louisville | BioHorizons, Inc. |
United States,
Araujo MG, da Silva JCC, de Mendonca AF, Lindhe J. Ridge alterations following grafting of fresh extraction sockets in man. A randomized clinical trial. Clin Oral Implants Res. 2015 Apr;26(4):407-412. doi: 10.1111/clr.12366. Epub 2014 Mar 12. — View Citation
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. — View Citation
Barone A, Ricci M, Tonelli P, Santini S, Covani U. Tissue changes of extraction sockets in humans: a comparison of spontaneous healing vs. ridge preservation with secondary soft tissue healing. Clin Oral Implants Res. 2013 Nov;24(11):1231-7. doi: 10.1111/j.1600-0501.2012.02535.x. Epub 2012 Jul 12. — View Citation
Jung RE, Philipp A, Annen BM, Signorelli L, Thoma DS, Hammerle CH, Attin T, Schmidlin P. Radiographic evaluation of different techniques for ridge preservation after tooth extraction: a randomized controlled clinical trial. J Clin Periodontol. 2013 Jan;40(1):90-8. doi: 10.1111/jcpe.12027. Epub 2012 Nov 19. — View Citation
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Leblebicioglu B, Salas M, Ort Y, Johnson A, Yildiz VO, Kim DG, Agarwal S, Tatakis DN. Determinants of alveolar ridge preservation differ by anatomic location. J Clin Periodontol. 2013 Apr;40(4):387-95. doi: 10.1111/jcpe.12065. Epub 2013 Feb 21. — View Citation
Llanos AH, Sapata VM, Jung RE, Hammerle CH, Thoma DS, Cesar Neto JB, Pannuti CM, Romito GA. Comparison between two bone substitutes for alveolar ridge preservation after tooth extraction: Cone-beam computed tomography results of a non-inferiority randomized controlled trial. J Clin Periodontol. 2019 Mar;46(3):373-381. doi: 10.1111/jcpe.13079. Epub 2019 Mar 3. — View Citation
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Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Alveolar ridge width | Alveolar ridge width (measured in mm) after 4 months of healing | 4 months | |
Primary | Alveolar ridge height | Alveolar ridge height (measured in mm) after 4 months of healing | 4 months | |
Primary | Buccal soft tissue thickness | Buccal soft tissue thickness at crest of alveolar ridge (measured in mm) | 4 months | |
Secondary | Percentage of vital bone present | Histologic measurement of the percentage of vital bone cells taken from core biopsy of grafted site at 4 months post-op | 4 months |
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