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

The University of Alabama at Birmingham logo

The University of Alabama at Birmingham

Status

Completed

Conditions

Unrestorable Dentition
Post-Extraction Sockets

Treatments

Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets
Procedure: AtraumaticTeeth Extraction

Study type

Interventional

Funder types

Other
Industry

Identifiers

NCT00641316
F071006001

Details and patient eligibility

About

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.

Full 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.

Enrollment

41 patients

Sex

All

Ages

19+ years old

Volunteers

Accepts Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

41 participants in 4 patient groups

1
Experimental group
Description:
Teeth extraction followed by natural healing
Treatment:
Procedure: AtraumaticTeeth Extraction
2- FDBA/TCP
Experimental group
Treatment:
Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets
Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets
Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets
3 FDBA/TCP+PRP
Experimental group
Treatment:
Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets
Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets
Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets
4 FDBA/TCP + PDGF
Experimental group
Treatment:
Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets
Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets
Procedure: Atraumatic Teeth Extraction/Grafted Extraction Sockets

Trial documents
1

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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