Effect of Bone Marrow Mononuclear Cell Layer Seeded on Platelet-rich Fibrin on an Alveolar Socket After Extraction

NCT05465421 | Unknown DMC

• 1 other identifier: cairoU21677
• Study Type: interventional
• Target: 24
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Decayed Teeth

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• postoperative pain

  14 days

Study Arms (2)

socket preservation with platelet rich fibrin PRF alone the implant placement 3 months after

ACTIVE COMPARATOR

after extraction socket preservation will be done by using PRF only in the socket and closed the socket by flap advancement.

Other: bone marrow aspiration from maxillary tuberosity and BMMNCs separation to be seeded on PRF and used for socket preservation

socket preservation with BMMNCs of bone marrow aspirated of maxillary tuberosity

EXPERIMENTAL

after extraction socket preservation will be done by using bone marrow mononuclear cell layer seeded on PRF in the socket and close the socket by flap advancement

Other: bone marrow aspiration from maxillary tuberosity and BMMNCs separation to be seeded on PRF and used for socket preservation

Interventions

bone marrow aspiration from maxillary tuberosity and BMMNCs separation to be seeded on PRF and used for socket preservation OTHER

Local anaesthesia will be administered by infiltration or nerve block to achieve the necessary anaesthesia to allow extraction of the indicated tooth Extraction will be done as atraumatically as possible removing any pathosis found that may interfere with bone formation A trapezoidal flap will be created above the extraction socket to allow closure of the surgical site. BMMNC will be seeded on platelet rich fibrin and inserted in the socket The flap will be closed by interrupted sutures using 5-0 sutures. implant placement 3 months later

socket preservation with BMMNCs of bone marrow aspirated of maxillary tuberosity; socket preservation with platelet rich fibrin PRF alone the implant placement 3 months after

Eligibility Criteria

• Age: 22 Years - 60 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Cairo University: lead

Study Sites (1)

Cairo University

Cairo, Egypt

RECRUITING

Related Publications (16)

• 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.

  PMID: 21529247 BACKGROUND

• 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.

  PMID: 26543482 BACKGROUND

• Wildburger A, Payer M, Jakse N, Strunk D, Etchard-Liechtenstein N, Sauerbier S. Impact of autogenous concentrated bone marrow aspirate on bone regeneration after sinus floor augmentation with a bovine bone substitute--a split-mouth pilot study. Clin Oral Implants Res. 2014 Oct;25(10):1175-81. doi: 10.1111/clr.12228. Epub 2013 Jul 22.

  PMID: 23875876 BACKGROUND

• Sauerbier S, Stricker A, Kuschnierz J, Buhler 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.

  PMID: 19473102 BACKGROUND

• 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. doi: 10.2106/00004623-199711000-00012.

  PMID: 9384430 BACKGROUND

• 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.

  PMID: 25052732 BACKGROUND

• 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.

  PMID: 24804168 BACKGROUND

• 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.

  PMID: 26800181 BACKGROUND

• 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. doi: 10.1902/jop.2006.050118.

  PMID: 16734586 BACKGROUND

• 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.

  PMID: 30196860 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.

  PMID: 15691354 BACKGROUND

• 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.

  PMID: 29456635 BACKGROUND

• 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.

  PMID: 31217377 BACKGROUND

• 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.

  PMID: 24066346 BACKGROUND

• Iorio-Siciliano V, Blasi A, Nicolo 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.

  PMID: 28817143 BACKGROUND

• 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.

  PMID: 18672985 BACKGROUND

Related Links

• Bone marrow concentrate and bovine bone mineral for sinus floor augmentation
• Maxillary Sinus Augmentation Combining Bio-Oss with the Bone Marrow Aspirate Concentrate
• Impact of autogenous concentrated bone marrow aspirate on bone regeneration after sinus floor augmentation with a bovine bone substitute
• In vivo comparison of hard tissue regeneration with human mesenchymal stem cells processed with either the FICOLL method or the BMAC method
• Aspiration to obtain osteoblast progenitor cells from human bone marrow: the influence of aspiration volume
• Osteogenic efficacy of bone marrow concentrate in rabbit maxillary sinus grafting
• Follow-up of implant survival comparing ficoll and bone marrow aspirate concentrate methods for hard tissue regeneration with mesenchymal stem cells in humans
• Double Centrifugation Versus Single Centrifugation of Bone Marrow Aspirate Concentrate in Sinus Floor Elevation: A Pilot Study
• Combining autologous bone marrow mononuclear cells seeded on collagen sponge with Nano Hydroxyapatite, and platelet-rich fibrin
• Dimensional ridge alterations following tooth extraction
• Clinical effect of platelet-rich fibrin on the preservation of the alveolar ridge following tooth extraction
• Bone marrow-derived mesenchymal stem cells enhance bone marrow regeneration in dental extraction sockets
• 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
• Clinical Outcomes of Socket Preservation Using Bovine-Derived Xenograft Collagen and Collagen Membrane Post-Tooth Extraction
• Xenograft versus extraction alone for ridge preservation after tooth removal

MeSH Terms

Conditions

Dental Caries

Condition Hierarchy (Ancestors)

Tooth Demineralization; Tooth Diseases; Stomatognathic Diseases

Study Officials

• Hani ElNahass

  Cairo University

  STUDY DIRECTOR

Central Study Contacts

Ahmed I Yassin

CONTACT

002 01063718668; ahmedyassin2167@gmail.com

omnia K Tawfik, lectuerer

CONTACT

002 01118881217; omnia.tawfik@dentistry.cu.edu.eg

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, OUTCOMES ASSESSOR
• Masking Details: Blinding of the participants and the operator is is not applicable, however outcome assessors and biostatistician will be blinded.
• Purpose: OTHER
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: clinical professor

Study Record Dates

• First Submitted: June 29, 2022
• First Posted: July 19, 2022
• Study Start: May 1, 2022
• Primary Completion: May 1, 2023
• Study Completion: May 1, 2023
• Last Updated: July 29, 2022

Record last verified: 2022-07

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)