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

Sponsor
University of Alabama at Birmingham (Other)
Overall Status
Completed
CT.gov ID
NCT00641316
Collaborator
BioHorizons, Inc. (Industry)
102
1
4
55
1.9

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • Procedure: AtraumaticTeeth Extraction
  • Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets
  • Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets
  • Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets
N/A

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.

Study Design

Study Type:
Interventional
Actual Enrollment :
102 participants
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
Study Start Date :
Apr 1, 2008
Actual Primary Completion Date :
Apr 1, 2010
Actual Study Completion Date :
Nov 1, 2012

Arms and Interventions

Arm Intervention/Treatment
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 Names:
  • 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 Names:
  • 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 Names:
  • 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 Names:
  • GEM-21
  • Outcome Measures

    Primary Outcome Measures

    1. Bone-fill in grafted post-extraction sockets versus bone-fill in non-grafted post-extraction sockets [2 months]

    Secondary Outcome Measures

    1. Survival of dental implants [24 months]

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    19 Years and Older
    Sexes Eligible for Study:
    All
    Accepts Healthy Volunteers:
    Yes
    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

    Locations

    Site City State Country Postal Code
    1 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

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    Responsible Party:
    Nicolaas C. Geurs, DDS, MS, Department Chair, University of Alabama at Birmingham
    ClinicalTrials.gov Identifier:
    NCT00641316
    Other Study ID Numbers:
    • F071006001
    First Posted:
    Mar 24, 2008
    Last Update Posted:
    Jul 16, 2021
    Last Verified:
    Feb 1, 2013
    Keywords provided by Nicolaas C. Geurs, DDS, MS, Department Chair, University of Alabama at Birmingham

    Study Results

    No Results Posted as of Jul 16, 2021