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An Assessment of Bone Augmentation in Post-Extraction Sockets (FMD-007)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00641316
First Posted: March 24, 2008
Last Update Posted: March 1, 2013
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Collaborator:
BioHorizons, Inc.
Information provided by (Responsible Party):
Michael Reddy, DMD, University of Alabama at Birmingham
  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

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (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 Michael Reddy, DMD, 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 ]

Secondary Outcome Measures:
  • Survival of dental implants [ Time Frame: 24 months ]

Enrollment: 102
Study Start Date: April 2008
Study Completion Date: November 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

Information from the National Library of Medicine

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Ages Eligible for Study:   19 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
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
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): 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:
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
First Submitted: March 17, 2008
First Posted: March 24, 2008
Last Update Posted: March 1, 2013
Last Verified: February 2013

Keywords provided by Michael Reddy, DMD, 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