Clinical Trials Directory

Trials / Completed

CompletedNCT00641316

An Assessment of Bone Augmentation in Post-Extraction Sockets

A Prospective Study of Bone Augmentation Techniques in Extraction Sockets and Implant Surface Textures

Status
Completed
Phase
N/A
Study type
Interventional
Enrollment
41 (actual)
Sponsor
University of Alabama at Birmingham · Academic / Other
Sex
All
Age
19 Years
Healthy volunteers
Accepted

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.

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.

Conditions

Interventions

TypeNameDescription
PROCEDUREAtraumaticTeeth ExtractionTeeth extraction alone, allowed to heal for 2 months followed by implant therapy to the sites
PROCEDUREAtraumatic Teeth Extraction/Grafted Extraction SocketsTeeth 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
PROCEDUREAtraumatic Teeth Extraction/Grafted Extraction SocketsTeeth 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
PROCEDUREAtraumatic Teeth Extraction/Grafted Extraction SocketsTeeth 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

Timeline

Start date
2008-04-01
Primary completion
2010-04-01
Completion
2012-11-01
First posted
2008-03-24
Last updated
2024-07-19
Results posted
2024-07-19

Locations

1 site across 1 country: United States

Source: ClinicalTrials.gov record NCT00641316. Inclusion in this directory is not an endorsement.