An Assessment of Bone Augmentation in Post-Extraction Sockets - Full Text View

Sponsor:	University of Alabama at Birmingham
Collaborator:	BioHorizons, Inc.
Information provided by (Responsible Party):	Michael Reddy, DMD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00641316

Purpose

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.

Condition	Intervention
Unrestorable Dentition Post-Extraction Sockets	Procedure: AtraumaticTeeth Extraction Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets

Study Type:	Interventional
Study Design:	Allocation: Randomized Endpoint Classification: Efficacy Study Intervention Model: Parallel Assignment Masking: Open Label Primary Purpose: Treatment
Official Title:	A Prospective Study of Bone Augmentation Techniques in Extraction Sockets and Implant Surface Textures

Further study details as provided by University of Alabama at Birmingham:

Primary Outcome Measures:

Bone-fill in grafted post-extraction sockets versus bone-fill in non-grafted post-extraction sockets [ Time Frame: 2 months ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

Survival of dental implants [ Time Frame: 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment:	80
Study Start Date:	April 2008
Estimated Study Completion Date:	June 2012
Primary Completion Date:	April 2010 (Final data collection date for primary outcome measure)

Arms	Assigned Interventions
Experimental: 1 Teeth extraction followed by natural healing	Procedure: AtraumaticTeeth Extraction Teeth extraction alone, allowed to heal for 2 months followed by implant therapy to the sites Other Name: Post-extraction socket healing
Experimental: 2- FDBA/TCP	Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets 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 Other Name: Allograft
Experimental: 3 FDBA/TCP+PRP	Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Autologous Platelet-Rich Plasma (PRP) allowed to heal for 2 months followed by dental implant therapy to the sites Other Name: Platelet-rich plasma
Experimental: 4 FDBA/TCP + PDGF	Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets Teeth extraction/post-extraction socket grafting with FDBA/TCP enriched with Platelet-Derived Growth Factors (PDGF) allowed to heal for 2 months followed by dental implant therapy to the sites Other Name: GEM-21

Detailed Description:

Tooth extraction is often associated with resorption of the alveolar ridge height and width and with compromised soft tissue contours. A variety of methods have been proposed to overcome varied patterns of post-extraction healing.

An increasingly common practice combines skilled surgical technique with post-extraction site grafting utilizing both natural and synthetic bone-graft materials. These procedures are thought to retard resorption of the socket volume while lending some control over bone-fill - thereby preserving the integrity of the alveolar ridge for future reconstruction with dental implants.

Limited evidence-based data exist to support a variety of bone-graft materials including grafts enriched with autologous platelet-rich plasma(PRP)and grafts enriched with recombinant human platelet-derived growth factors(PDGF). Despite emerging clinical acceptance the most efficacious intervention remains undetermined.

In an effort to establish clinical evidence, this study will assess the efficacy of ridge preservation using three different bone grafting applications in post-extraction sockets compared to extraction alone.

The study will also asses longitudinal success of restoring the study sites with dental implants. Two innovative dental implant designs will be used in the study; an implant with a resorbable blast textured(RBT)surface and an implant with a laser thread-textured (LTT)surface.

Eligibility

Ages Eligible for Study:	19 Years and older
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	Yes

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Inability to provide informed consent in English
Pregnant women

Contacts and Locations

Please refer to this study by its ClinicalTrials.gov identifier: NCT00641316

Locations

United States, Alabama
University of Alabama at Birmingham School of Dentistry
Birmingham, Alabama, United States, 35294 0007

Sponsors and Collaborators

University of Alabama at Birmingham

BioHorizons, Inc.

Investigators

Principal Investigator:	Michael S Reddy, DMD, DMSc	University of Alabama at Birmingham
Principal Investigator:	Nicolaas C Geurs, DDS, MS	University of Alabama at Birmingham

More Information

Publications:

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. Erratum in: J Oral Maxillofac Surg. 2005 Jan;63(1):158.

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.

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.

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.

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.

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.

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.

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.

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.

Marx RE. Platelet-rich plasma: evidence to support its use. J Oral Maxillofac Surg. 2004 Apr;62(4):489-96. Review. No abstract available.

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.

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

Responsible Party:	Michael Reddy, DMD, Interin Dean, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:	NCT00641316 History of Changes
Other Study ID Numbers:	F071006001
Study First Received:	March 17, 2008
Last Updated:	October 3, 2011
Health Authority:	United States: Institutional Review Board

Keywords provided by University of Alabama at Birmingham:

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

ClinicalTrials.gov processed this record on February 09, 2012