Decayed Teeth Clinical Trial
Official title:
Clinical and Radiographic Assessment of Buccolingual Bone Dimension Following Socket Preservation With Bone Marrow Mono-nuclear Cell From the Maxillary Tuberosity Combined With Platelet-rich Fibrin Compared With Platelet-rich Fibrin Alone
NCT number | NCT05465421 |
Other study ID # | cairoU21677 |
Secondary ID | |
Status | Recruiting |
Phase | N/A |
First received | |
Last updated | |
Start date | May 1, 2022 |
Est. completion date | May 1, 2023 |
Bone marrow aspiration from maxillary tuberosity will be centrifuged to separate the bone marrow mononuclear cell layer using the density gradient separation method, then it will be seeded in a platelet-rich fibrin membrane and used for socket preservation to test the osteogenic ability of the bone marrow mononuclear cell layer in comparison to platelet-rich fibrin alone both ways will receive implant after 3 months
Status | Recruiting |
Enrollment | 24 |
Est. completion date | May 1, 2023 |
Est. primary completion date | May 1, 2023 |
Accepts healthy volunteers | Accepts Healthy Volunteers |
Gender | All |
Age group | 22 Years to 60 Years |
Eligibility | Inclusion Criteria: - Patients with badly decayed tooth indicated for extraction - Patients with healthy systemic condition (Medically free) - Adequate inter-arch space for placement of the implant prosthetic part. - Good oral hygiene - Cooperative patients who are willing to commit for 6 months follow up Exclusion Criteria: - Smokers - Pregnant females - Patient with medical condition that contraindicates surgical procedures - Patients on medication that may interfere with healing (corticosteroids, bisphosphonate, Chemo/radio therapy). - Patients with habits that may jeopardize the implant longevity and affect the results of the study such as alcoholism or parafunctional habits. |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo University | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Al-Ahmady HH, Abd Elazeem AF, Bellah Ahmed NE, Shawkat WM, Elmasry M, Abdelrahman MA, Abderazik MA. Combining autologous bone marrow mononuclear cells seeded on collagen sponge with Nano Hydroxyapatite, and platelet-rich fibrin: Reporting a novel strategy for alveolar cleft bone regeneration. J Craniomaxillofac Surg. 2018 Sep;46(9):1593-1600. doi: 10.1016/j.jcms.2018.05.049. Epub 2018 Jun 2. — View Citation
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
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
de Oliveira TA, Aloise AC, Orosz JE, de Mello E Oliveira R, de Carvalho P, Pelegrine AA. Double Centrifugation Versus Single Centrifugation of Bone Marrow Aspirate Concentrate in Sinus Floor Elevation: A Pilot Study. Int J Oral Maxillofac Implants. 2016 Jan-Feb;31(1):216-22. doi: 10.11607/jomi.4170. — View Citation
Duttenhoefer F, Hieber SF, Stricker A, Schmelzeisen R, Gutwald R, Sauerbier S. Follow-up of implant survival comparing ficoll and bone marrow aspirate concentrate methods for hard tissue regeneration with mesenchymal stem cells in humans. Biores Open Access. 2014 Apr 1;3(2):75-6. doi: 10.1089/biores.2014.0003. — View Citation
Gapski R, Satheesh K, Cobb CM. Histomorphometric analysis of bone density in the maxillary tuberosity of cadavers: a pilot study. J Periodontol. 2006 Jun;77(6):1085-90. — View Citation
Iorio-Siciliano V, Blasi A, Nicolò M, Iorio-Siciliano A, Riccitiello F, Ramaglia L. Clinical Outcomes of Socket Preservation Using Bovine-Derived Xenograft Collagen and Collagen Membrane Post-Tooth Extraction: A 6-Month Randomized Controlled Clinical Trial. Int J Periodontics Restorative Dent. 2017 Sep/Oct;37(5):e290-e296. doi: 10.11607/prd.2474. — View Citation
Marx RE, Tursun R. A qualitative and quantitative analysis of autologous human multipotent adult stem cells derived from three anatomic areas by marrow aspiration: tibia, anterior ilium, and posterior ilium. Int J Oral Maxillofac Implants. 2013 Sep-Oct;28(5):e290-4. doi: 10.11607/jomi.te10. — View Citation
Mashimo T, Sato Y, Akita D, Toriumi T, Namaki S, Matsuzaki Y, Yonehara Y, Honda M. Bone marrow-derived mesenchymal stem cells enhance bone marrow regeneration in dental extraction sockets. J Oral Sci. 2019;61(2):284-293. doi: 10.2334/josnusd.18-0143. — View Citation
Muschler GF, Boehm C, Easley K. Aspiration to obtain osteoblast progenitor cells from human bone marrow: the influence of aspiration volume. J Bone Joint Surg Am. 1997 Nov;79(11):1699-709. Erratum in: J Bone Joint Surg Am 1998 Feb;80(2):302. — View Citation
Pasquali PJ, Teixeira ML, de Oliveira TA, de Macedo LG, Aloise AC, Pelegrine AA. Maxillary Sinus Augmentation Combining Bio-Oss with the Bone Marrow Aspirate Concentrate: A Histomorphometric Study in Humans. Int J Biomater. 2015;2015:121286. doi: 10.1155/2015/121286. Epub 2015 Oct 12. — View Citation
Sauerbier S, Rickert D, Gutwald R, Nagursky H, Oshima T, Xavier SP, Christmann J, Kurz P, Menne D, Vissink A, Raghoebar G, Schmelzeisen R, Wagner W, Koch FP. Bone marrow concentrate and bovine bone mineral for sinus floor augmentation: a controlled, randomized, single-blinded clinical and histological trial--per-protocol analysis. Tissue Eng Part A. 2011 Sep;17(17-18):2187-97. doi: 10.1089/ten.TEA.2010.0516. Epub 2011 Jun 24. — View Citation
Sauerbier S, Stricker A, Kuschnierz J, Bühler F, Oshima T, Xavier SP, Schmelzeisen R, Gutwald R. In vivo comparison of hard tissue regeneration with human mesenchymal stem cells processed with either the FICOLL method or the BMAC method. Tissue Eng Part C Methods. 2010 Apr;16(2):215-23. doi: 10.1089/ten.TEC.2009.0269. — View Citation
Sununliganon L, Peng L, Singhatanadgit W, Cheung LK. Osteogenic efficacy of bone marrow concentrate in rabbit maxillary sinus grafting. J Craniomaxillofac Surg. 2014 Dec;42(8):1753-65. doi: 10.1016/j.jcms.2014.06.011. Epub 2014 Jun 14. — View Citation
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Zhang Y, Ruan Z, Shen M, Tan L, Huang W, Wang L, Huang Y. Clinical effect of platelet-rich fibrin on the preservation of the alveolar ridge following tooth extraction. Exp Ther Med. 2018 Mar;15(3):2277-2286. doi: 10.3892/etm.2018.5696. Epub 2018 Jan 4. — View Citation
* Note: There are 16 references in all — Click here to view all references
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | bucco-palatal width of the alveolar socket after extraction with millimeter by cone-beam computed tomography (CBCT) | The bucco-palatal width of the alveolar socket after extraction will be measured in millimeter using On Demand software at distinct level (2 , 4, and 6mm from the cerst) at the time of extraction and 3 months later after socket preservation with cone-beam computed tomography (CBCT) | 3 months after extraction and socket preservation | |
Secondary | postoperative pain | postoperative pain after the surgery, Visual analogue score from (1 to 10) and 10 is the worst pain
-A patient is asked to indicate his/her perceived pain intensity (most commonly) along a 100 mm horizontal line, and this rating is then measured from the left edge |
14 days |
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