An Assessment of Bone Augmentation in Post-Extraction Sockets

NCT00641316 | Completed Results DMC

• 1 other identifier: F071006001
• Study Type: interventional
• Target: 41
• Locations: 1 country
• Sites: 1

Brief Summary

When a tooth is extracted the ridge of bone that held the tooth in place begins to heal and over time new bone grows to fill the empty space left by the missing tooth. Sometimes this process works very well and new bone grows to completely fill the socket, at other times new bone fails to fill in the space completely and patients are left with uneven bone-fill. Grafted extraction sockets may fill with bone faster and more evenly than those without grafts, allowing the dentist to have greater control over the healing process and to repair the area with dental implants in a shorter period of time. This study will help determine if grafting an extraction socket, with or without enriching the graft material, is an added benefit when compared to allowing the socket to heal naturally. The study will also assess how well two different dental implant designs used to restore the area will function over time.

Conditions

Unrestorable Dentition; Post-Extraction Sockets

Keywords

Freeze-dried bone allograft; Platelet-rich plasma; Platelet-derived growth factors; Laser-threaded dental implants; Resorbable blast textured dental implants

Outcome Measures

Primary Outcomes (1)

• Bone-fill in Grafted Post-extraction Sockets Versus Bone-fill in Non-grafted Post-extraction Sockets

  New bone formation in grafted extraction sockets to that of sites healed after 8 weeks of post-extraction.

  2 months

Study Arms (4)

1

EXPERIMENTAL

Teeth extraction followed by natural healing

Procedure: AtraumaticTeeth Extraction

2- FDBA/TCP

EXPERIMENTAL

Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets

3 FDBA/TCP+PRP

EXPERIMENTAL

Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets

4 FDBA/TCP + PDGF

EXPERIMENTAL

Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets

Interventions

AtraumaticTeeth Extraction PROCEDURE

Teeth extraction alone, allowed to heal for 2 months followed by implant therapy to the sites

Also known as: Post-extraction socket healing

1

Atraumatic Teeth Extraction/Grafted Extraction Sockets PROCEDURE

Teeth extraction/post-extraction socket grafting with Freeze-Dried Bone Allograft (FDBA) mixed with Tri-Calcium Phosphate(TCP) allowed to heal for 2 months followed by dental implant therapy to the sites

Also known as: Allograft

2- FDBA/TCP

Eligibility Criteria

• Age: 19 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Needed extraction of Maxillary and/or Mandibular Incisors and/or Pre-molar teeth

You may not qualify if:

• Inability to provide informed consent in English
• Pregnant women

Sponsors & Collaborators

• University of Alabama at Birmingham: lead
• BioHorizons, Inc.: collaborator

Study Sites (1)

University of Alabama at Birmingham School of Dentistry

Birmingham, Alabama, 35294 0007, United States

Location

Related Publications (12)

• Sclar AG. Strategies for management of single-tooth extraction sites in aesthetic implant therapy. J Oral Maxillofac Surg. 2004 Sep;62(9 Suppl 2):90-105. doi: 10.1016/j.joms.2004.06.041.

  PMID: 15332186 BACKGROUND

• Lekovic V, Kenney EB, Weinlaender M, Han T, Klokkevold P, Nedic M, Orsini M. A bone regenerative approach to alveolar ridge maintenance following tooth extraction. Report of 10 cases. J Periodontol. 1997 Jun;68(6):563-70. doi: 10.1902/jop.1997.68.6.563.

  PMID: 9203100 BACKGROUND

• Lekovic V, Camargo PM, Klokkevold PR, Weinlaender M, Kenney EB, Dimitrijevic B, Nedic M. Preservation of alveolar bone in extraction sockets using bioabsorbable membranes. J Periodontol. 1998 Sep;69(9):1044-9. doi: 10.1902/jop.1998.69.9.1044.

  PMID: 9776033 BACKGROUND

• Artzi Z, Tal H, Dayan D. Porous bovine bone mineral in healing of human extraction sockets. Part 1: histomorphometric evaluations at 9 months. J Periodontol. 2000 Jun;71(6):1015-23. doi: 10.1902/jop.2000.71.6.1015.

  PMID: 10914806 BACKGROUND

• Artzi Z, Tal H, Dayan D. Porous bovine bone mineral in healing of human extraction sockets: 2. Histochemical observations at 9 months. J Periodontol. 2001 Feb;72(2):152-9. doi: 10.1902/jop.2001.72.2.152.

  PMID: 11288787 BACKGROUND

• Froum S, Cho SC, Rosenberg E, Rohrer M, Tarnow D. Histological comparison of healing extraction sockets implanted with bioactive glass or demineralized freeze-dried bone allograft: a pilot study. J Periodontol. 2002 Jan;73(1):94-102. doi: 10.1902/jop.2002.73.1.94.

  PMID: 11846205 BACKGROUND

• Zubillaga G, Von Hagen S, Simon BI, Deasy MJ. Changes in alveolar bone height and width following post-extraction ridge augmentation using a fixed bioabsorbable membrane and demineralized freeze-dried bone osteoinductive graft. J Periodontol. 2003 Jul;74(7):965-75. doi: 10.1902/jop.2003.74.7.965.

  PMID: 12931758 BACKGROUND

• 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. doi: 10.1902/jop.2003.74.7.990.

  PMID: 12931761 BACKGROUND

• Anitua E. Plasma rich in growth factors: preliminary results of use in the preparation of future sites for implants. Int J Oral Maxillofac Implants. 1999 Jul-Aug;14(4):529-35.

  PMID: 10453668 BACKGROUND

• Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. doi: 10.1016/j.joms.2003.12.003. No abstract available.

  PMID: 15085519 BACKGROUND

• Nevins M, Giannobile WV, McGuire MK, Kao RT, Mellonig JT, Hinrichs JE, McAllister BS, Murphy KS, McClain PK, Nevins ML, Paquette DW, Han TJ, Reddy MS, Lavin PT, Genco RJ, Lynch SE. Platelet-derived growth factor stimulates bone fill and rate of attachment level gain: results of a large multicenter randomized controlled trial. J Periodontol. 2005 Dec;76(12):2205-15. doi: 10.1902/jop.2005.76.12.2205.

  PMID: 16332231 BACKGROUND

• Reddy M, Giannoble E, Nevins M, McGuire M. Kao R, Lynch S. Multicentered radiographic analysis of a regenerative medicine approach to periodontal bone destruction. Southeast Workshop on Tissue Engineering and Biomaterials 2nd Annual February 11-12, 2005

  BACKGROUND

MeSH Terms

Interventions

Transplantation, Homologous

Intervention Hierarchy (Ancestors)

Transplantation; Surgical Procedures, Operative

Results Point of Contact

• Title: Nicolaas Geurs, DDS,MS
• Organization: University of Alabama at Birmingham

ngeurs@uab.edu

2059344506

Study Officials

• Michael S Reddy, DMD, DMSc

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

• Nicolaas C Geurs, DDS, MS

  University of Alabama at Birmingham

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Department Chair

Study Record Dates

• First Submitted: March 17, 2008
• First Posted: March 24, 2008
• Study Start: April 1, 2008
• Primary Completion: April 1, 2010
• Study Completion: November 1, 2012
• Last Updated: July 19, 2024
• Results First Posted: July 19, 2024

Record last verified: 2024-07

Locations

US (1)