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

This study has been completed.
Sponsor:
Collaborator:
BioHorizons, Inc.
Information provided by (Responsible Party):
Michael Reddy, DMD, University of Alabama at Birmingham
ClinicalTrials.gov Identifier:
NCT00641316
First received: March 17, 2008
Last updated: February 27, 2013
Last verified: February 2013
  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 ]

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

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:
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: February 27, 2013
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 April 16, 2014