Clinical trial NCT00641316: An Assessment of Bone Augmentation in Post-Extraction Sockets
Official title: A Prospective Study of Bone Augmentation Techniques in Extraction Sockets and Implant Surface Textures
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Unrestorable Dentition
Post-Extraction Sockets
Keywords: Freeze-dried bone allograft
Platelet-rich plasma
Platelet-derived growth factors
Laser-threaded dental implants
Resorbable blast textured dental implants
Lead sponsor: University of Alabama at Birmingham
Sponsor class: OTHER
Collaborators: name: BioHorizons, Inc.
First posted: 2008-03-24
Enrollment: 41
Sex: ALL
Minimum age (years): 19
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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 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

Primary outcomes:
measure: Bone-fill in Grafted Post-extraction Sockets Versus Bone-fill in Non-grafted Post-extraction Sockets
timeFrame: 2 months
Secondary outcomes:
Other outcomes:
Locations:
city: Birmingham
country: United States
facility: University of Alabama at Birmingham School of Dentistry
state: Alabama
Study officials:
affiliation: University of Alabama at Birmingham
name: Michael S Reddy, DMD, DMSc
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Alabama at Birmingham
name: Nicolaas C Geurs, DDS, MS
role: PRINCIPAL_INVESTIGATOR
References:
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citation: Zubillaga G, Von Hagen S, Simon BI, Deasy MJ. Changes in alveolar bone height and width following post-extraction ridge augmentation using a fixed bioabsorbable membrane and demineralized freeze-dried bone osteoinductive graft. J Periodontol. 2003 Jul;74(7):965-75. doi: 10.1902/jop.2003.74.7.965.
citation: Iasella JM, Greenwell H, Miller RL, Hill M, Drisko C, Bohra AA, Scheetz JP. Ridge preservation with freeze-dried bone allograft and a collagen membrane compared to extraction alone for implant site development: a clinical and histologic study in humans. J Periodontol. 2003 Jul;74(7):990-9. doi: 10.1902/jop.2003.74.7.990.
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